Gynecological cancer survivors' experiences with sexual health communication in nurse-led follow-up consultations.

INTRODUCTION: Gynecological cancer and its treatment may cause sexual difficulties in terms of physical and psychosocial health. Considering the essential role that nurses play in cancer care, they are well positioned to be ideal providers for addressing sexual health concerns in the follow-up phase of gynecological cancer. The aim of this study was to gain in-depth knowledge of how gynecological cancer survivors experience sexual health communication in nurse-led follow-up consultations. MATERIAL AND METHODS: Using a qualitative hermeneutic approach, we conducted individual semi-structured interviews with 17 women from five different hospitals in Norway between April 4, 2022, and June 2, 2022. The women participated in a large intervention study on cancer follow-up that included sexual health as one of several topics addressed by trained nurses in three consultations in the first year of follow-up. A five-stage Gadamerian-inspired research method was utilized for data collection and analysis. RESULTS: We identified three themes: (1) the importance of nurses listening to the women's own perceptions of sexuality, (2) post-treatment sexual challenges influence the women's need to communicate about sexual health, and (3) nursing communication can help women regain their sexual health. CONCLUSIONS: Women who have undergone treatment for gynecological cancer find communication with trained nurses regarding sexual health beneficial. We recommend integration of trained nurses in the follow-up team. The nurses should adjust communication according to each gynecological cancer survivor's unique understanding of sexuality and inform women with sexual health concerns at that end of treatment, that sexual health can improve during follow-up.

Time trends in human papillomavirus prevalence and genotype distribution in vulvar carcinoma in Norway.

INTRODUCTION: Approximately 25%-43% of all vulvar carcinomas are associated with human papillomavirus (HPV). In many countries, vulvar carcinoma incidence rates are increasing, possibly due to greater HPV exposure. However, studies exploring changes in HPV prevalence and genotype distribution in vulvar carcinoma over time are scarce. Our aim was to evaluate time trends in HPV prevalence and genotype distribution in vulvar squamous cell carcinoma in an unselected, nationwide sample of Norwegian women. Further, we explored clinical and histopathological aspects in relation to HPV status and investigated whether HPV status was associated with survival. MATERIAL AND METHODS: All vulvar squamous cell carcinoma cases from 1970-1975 and 2000-2005 were extracted from the Cancer Registry of Norway and corresponding tissue blocks were retrieved. After detailed histology review, HPV testing was conducted using real-time TaqMan PCR. Overall survival rates were calculated using the Kaplan-Meier method. Multivariable Cox regression analysis was performed to estimate hazard ratios adjusted for age at diagnosis, stage and diagnostic period. RESULTS: Histological review was performed on 352 vulvar squamous cell carcinoma cases. We were able to obtain valid HPV analysis results for 282 cases, Overall, 29.8% (95% CI 24.5%-35.5%) of cases were high-risk HPV (hrHPV)-positive. When comparing the two periods, we found that the percentage of hrHPV-positive tumors increased significantly from 23% (95% CI 16.0%-31.4%) in 1970-1975 to 35.3% (95% CI 27.8%-43.3%) in 2000-2005 (P = 0.025). The predominant genotypes were HPV 16 (73%), HPV 33 (21%), and HPV 18 (6%), with similar distributions in both periods. In the more recent cohort, several additional genotypes were detected: HPV 6, 11, 39, 45, 52, 58 and 66 were found in smaller percentages, ranging from 1.8% to 3.6%. In univariate analysis, patients with HPV-positive tumors showed improved overall survival compared with patients with HPV-negative tumors (hazard ratio [HR] 0.65, 95% CI 0.48-0.86). CONCLUSIONS: The prevalence of HPV in vulvar squamous cell carcinomas in Norway was significantly higher in 2000-2005 than in 1970-1975. The three predominant genotypes were HPV 16, 33 and 18 in both time periods. However, several other HPV genotypes have emerged over the last decades. HPV-positivity was associated with better overall survival.

Dropout from exercise trials among cancer survivors-An individual patient data meta-analysis from the POLARIS study.

INTRODUCTION: The number of randomized controlled trials (RCTs) investigating the effects of exercise among cancer survivors has increased in recent years; however, participants dropping out of the trials are rarely described. The objective of the present study was to assess which combinations of participant and exercise program characteristics were associated with dropout from the exercise arms of RCTs among cancer survivors. METHODS: This study used data collected in the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) study, an international database of RCTs investigating the effects of exercise among cancer survivors. Thirty-four exercise trials, with a total of 2467 patients without metastatic disease randomized to an exercise arm were included. Harmonized studies included a pre and a posttest, and participants were classified as dropouts when missing all assessments at the post-intervention test. Subgroups were identified with a conditional inference tree. RESULTS: Overall, 9.6% of the participants dropped out. Five subgroups were identified in the conditional inference tree based on four significant associations with dropout. Most dropout was observed for participants with BMI >28.4 kg/m2 , performing supervised resistance or unsupervised mixed exercise (19.8% dropout) or had low-medium education and performed aerobic or supervised mixed exercise (13.5%). The lowest dropout was found for participants with BMI >28.4 kg/m2 and high education performing aerobic or supervised mixed exercise (5.1%), and participants with BMI ≤28.4 kg/m2 exercising during (5.2%) or post (9.5%) treatment. CONCLUSIONS: There are several systematic differences between cancer survivors completing and dropping out from exercise trials, possibly affecting the external validity of exercise effects.

Real-world data on niraparib maintenance treatment in patients with non-gBRCA mutated platinum-sensitive recurrent ovarian cancer.

OBJECTIVES: The aim of this study was to provide real-world efficacy and safety data on niraparib maintenance treatment in patients with non-germline (gBRCA)1/2 mutated platinum-sensitive recurrent ovarian cancer. METHODS: This retrospective multi-center cohort study included 94 platinum-sensitive recurrent ovarian cancer patients without known gBRCA1/2 mutation treated in an individual patient access program in Norway. The primary outcome was time from start of niraparib treatment to first subsequent treatment. Secondary endpoints included progression-free survival, safety, and tolerability. RESULTS: After median follow-up of 13.4 months (95% confidence interval (CI) 10.0 to 16.8), 68.1% had progressed and 22.3% had died. Of the entire cohort, 61.7% had commenced a new line of treatment, and 24.5% were still receiving niraparib. The median duration of niraparib treatment was 5.0 months (range 0.4 to 27.3), and the median time to first subsequent treatment was 10.7 months (95% CI 8.4 to 13.0). Patients with elevated CA125 prior to start of niraparib had shorter time to first subsequent treatment (7.3 months, 95% CI 4.2 to 10.3) than patients with normalized CA125 (12.2 months, 95% CI 10.9 to 13.7 (p=0.002). Patients who started on individual dose based on weight and platelet counts had fewer dose reductions (p<0.001) and interruptions (p=0.02). CONCLUSION: In a real-world setting, niraparib maintenance treatment in patients with non-gBRCA1/2 mutated recurrent platinum-sensitive ovarian cancer showed effectiveness comparable with published phase III studies and acceptable safety. Individualized dosing is essential to minimize adverse events. CA125 levels at start of niraparib treatment may help to estimate the individual prognosis.

Nurse-patient sexual health communication in gynaecological cancer follow-up: A qualitative study from nurses' perspectives.

AIM: To explore nurse-patient sexual health communication from the perspectives of nurses trained to address sexual health in gynaecological cancer follow-up. DESIGN: A qualitative hermeneutic approach. METHODS: Individual semi-structured interviews with 10 nurses at five different hospitals in Norway were conducted in March and April 2021. A Gadamerian-inspired research method was used in the analysis. RESULTS: Three main themes with six sub-themes were identified. The three main themes were: (1) building relationships through communication, (2) practice makes perfect-the importance of experience and knowledge, and (3) personal attitudes as promoters or inhibiters of sexual health communication. CONCLUSION: This study provides valuable insights into nurse-patient sexual health communication from the perspectives of nurses. The nurses in this study experienced the importance of having a good, respectful nurse-patient relationship as the foundation for sexual health communication. The professional confidence gained through experience and knowledge was emphasized, including the significance of how attitudes and taboos can influence sexual health communication. IMPACT: The main findings of this study indicate that training in sexual health communication and the possibility of addressing sexual health repeatedly give nurses skills and professional confidence to address sexual health in cancer follow-up. Our study indicates that sexual health communication can be achieved in a clinical setting without being overly resource demanding. Our results may also motivate nurses to enhance their knowledge about sexual health in cancer follow-ups. PATIENT OR PUBLIC CONTRIBUTION: A patient representative from the Norwegian Gynaecological Cancer Society have been involved in the planning of this study. She has given valuable contributions from the view of a gynaecological cancer patient.

Longitudinal effects of adjuvant chemotherapy and lymph node staging on patient-reported outcomes in endometrial cancer survivors: a prospective cohort study.

BACKGROUND: Most patients with endometrial cancer with localized disease are effectively treated and survive for a long time. The primary treatment is hysterectomy, to which surgical staging procedures may be added to assess the need for adjuvant therapy. Longitudinal data on patient-reported outcomes comparing different levels of primary treatment are lacking, especially when adjuvant radiotherapy is omitted. OBJECTIVE: We assessed the impact of lymphadenectomy and adjuvant chemotherapy on patient-reported symptoms, function, and quality of life. We hypothesized that these treatment modalities would substantially affect patient-reported outcomes at follow-up. STUDY DESIGN: We prospectively included patients with endometrial cancer enrolled in the ongoing MoMaTEC2 study (ClinicalTrials.gov Identifier: NCT02543710). Patients were asked to complete the patient-reported outcome questionnaires European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EN24 preoperatively and at 1 and 2 years of follow-up. Functional domains and symptoms were analyzed for the whole cohort and by treatment received. To assess the effect of the individual treatment modifications, we used mixed regression models. RESULTS: Baseline data were available for 448 patients. Of these patients, 339 and 219 had reached 1-year follow-up and 2-year follow-up, respectively. Treatment included hysterectomy (plus bilateral salpingo-oophorectomy) alone (n=177), hysterectomy and lymph node staging without adjuvant therapy (n=133), or adjuvant chemotherapy irrespective of staging procedure (n=138). Overall, patients reported improved global health status and quality of life (+9 units; P<.001), increased emotional and social functioning, and increased sexual interest and activity (P<.001 for all) from baseline to year 1, and these outcomes remained stable at year 2. Means of functional scales and quality of life were similar to age- and sex-weighted reference cohorts. Mean tingling and numbness and lymphedema increased after treatment. The group who received adjuvant chemotherapy had a larger mean reduction in physical functioning (-6 vs +2; P=.002) at year 1, more neuropathy (+30 vs +5; P<.001; year 1) at years 1 and 2, and more lymphedema at year 1 (+11 vs +2; P=.007) than the group treated with hysterectomy and salpingo-oophorectomy only. In patients not receiving adjuvant chemotherapy, patient-reported outcomes were similar regardless of lymph node staging procedures. Adjuvant chemotherapy independently increased fatigue, lymphedema, and neuropathy in mixed regression models. CONCLUSION: Patients with endometrial cancer receiving adjuvant chemotherapy reported significantly reduced functioning and more symptoms up to 2 years after treatment. For patients treated by surgery alone, surgical staging did not seem to affect the quality of life or symptoms to a measurable degree at follow-up. Therefore, subjecting patients to lymph node removal to tailor adjuvant therapy seems justified from the patient's viewpoint; however, efforts should increase to find alternatives to traditional chemotherapy.

Symptomatic or asymptomatic recurrence of ovarian cancer: does it influence survival?

OBJECTIVE: The survival benefit of monitoring CA125 in ovarian cancer patients after primary treatment is debated due to findings varying from insignificant survival differences to prolonged median overall survival in favor of asymptomatic patients. Hence we aimed to compare ovarian cancer patients with and without symptoms at the time of the first diagnosed recurrence in terms of post-recurrence survival and overall survival, and to explore time to recurrence and common symptoms at recurrence. METHODS: We included 421 women with ovarian cancer from a prospective multi-institutional Norwegian study of first recurrence of gynecological cancer over the period from March 2012 to April 2016. Patients were interviewed by clinicians at participating hospitals, and patient reported and clinical variables were recorded in a standardized questionnaire. The Kaplan-Meier method and the multivariate Cox model were used to evaluate post-recurrence survival and overall survival. RESULTS: Of the 406 patients included, 183 (45%) patients were diagnosed with asymptomatic recurrence, and 223 (55%) patients had symptoms at recurrence. Asymptomatic patients had their recurrence detected 2 months later than symptomatic patients (14 vs 12 months, respectively, p=0.17). Median post-recurrence survival was significantly longer in asymptomatic patients compared with patients with symptoms at recurrence (33.9 vs 26.2 months, respectively, p=0.002). The post-recurrence survival rate remained higher for symptomatic patients in the adjusted analysis (hazard ratio (HR)=1.42, p=0.001). Median overall survival was 47.8 months for asymptomatic patients versus 44.0 months for symptomatic patients in the unadjusted analyses (p=0.056). Asymptomatic patients had a significantly longer survival in the adjusted analysis (HR=1.24, p=0.046). Pain was the most common symptom at recurrence (54%). CONCLUSION: Patients with asymptomatic recurrence had a better prognosis based on post-recurrence data and the multivariate Cox regression analysis of overall survival. However, a closer exploration of differences in development of recurrence is needed as these results may give rise to more individualized follow-up for ovarian cancer patients.

Nurse-led consultations reinforced with eHealth technology: a qualitative study of the experiences of patients with gynecological cancer.

BACKGROUND: During the last decade, the health care profession has moved toward personalized care and has focused on the diversity of survivorship needs after initial cancer treatment. Health care providers encourage empowering patients to participate actively in their own health management and survivorship. Consequently, we developed and piloted a new follow-up model for patients at a Norwegian hospital, referred to as the Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology (LETSGO) model. Using LETSGO, a dedicated nurse replaces the physician in every second follow-up consultation, providing patients who have undergone cancer treatment with self-management techniques that are reinforced with eHealth technology via a specially designed app. Encouraging behavioral change and evaluating the late effects of treatment and recurrence symptoms are central components of self-management techniques. In addition, the app encourages physical activity and positive lifestyle changes, helps identify recurrence-related symptoms, and provides reminders of activity goals. This study aims to investigate experiences with nurse-led consultations supported by eHealth technology among the patients who piloted the LETSGO intervention. METHODS: Semi-structured qualitative interviews were conducted to analyze the participants' experiences with the LETSGO intervention after six to seven months. RESULTS: The participants in the LETSGO pilot felt safe and well cared for. They thought the nurse was less busy than the doctors appear to be, which made it easy for them to share any cancer-related challenges. Many participants reported increased empowerment and confidence in recognizing symptoms of cancer recurrence, and participants who used the app regularly were motivated to increase their physical activity levels. However, the participants also experienced some limitations and technical errors with the app. CONCLUSIONS: Generally, the participants positively received the nurse-led consultations and eHealth technology, but an intervention study is required for further evaluation. In addition, the reported technical app errors should be resolved and tested prior to eHealth application implementation. Regardless, this study may be useful in planning personalized survivorship care studies. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03453788 . Registration March 5, 2018.

Self-management and adherence to recommended follow-up after gynaecological cancer: results from the international InCHARGE study.

OBJECTIVE: To assess the relationship between self-management skills and adherence to follow-up guidelines among gynecological cancer survivors in the Netherlands, Norway, and Denmark, and to assess the relationship between adherence to follow-up programs and use of additional healthcare services. METHODS: For this international, multicenter, cross-sectional study, we recruited gynecological cancer survivors 1-5 years after completion of treatment. Information on follow-up visits, use of healthcare resources, self-management (measured by the Health Education Impact Questionnaire), clinical characteristics, and demographics were obtained by validated questionnaires. Participants were categorized as adherent if they attended the number of follow-up visits recommended by national guidelines, non-adherent if they had fewer visits than recommended, or over-users if they had more visits than recommended. RESULTS: Of 4455 invited survivors, 2428 (55%) returned the questionnaires, and 911 survivors were included in the analyses. Survivors with high self-management most frequently adhered to recommended follow-up. Non-adherent survivors showed lower self-management in the health-directed activity domain (OR 1.54, 95% CI 1.03 to 2.32) than adherent survivors. No other associations between self-management and follow-up adherence were revealed. Non-adherent survivors tended to have endometrial cancer, surgical treatment only, be older, and be Danish residents. Over-users reported more follow-up visits and also used additional healthcare services more frequently than adherent survivors. CONCLUSION: Low self-management appears to reduce the likelihood of adherence to national guidelines for gynecological cancer follow-up. Focusing on patient education for survivors at risk of low self-management to ensure adherence to recommended follow-up may improve personalization of follow-up.

The association between intrapartum opioid fentanyl and early breastfeeding: A prospective observational study.

INTRODUCTION: Intrapartum opioids in labor may interfere with the early breastfeeding phase and cause breastfeeding difficulties. This study examines the effects of intrapartum fentanyl given intravenously (IV) or through epidural analgesia (EDA) on early breastfeeding. MATERIAL AND METHODS: This is a prospective observational study conducted in a regional maternity unit. We included 1101 healthy mothers of term singleton babies in vertex presentation born between 2016 and 2018 (468 nulliparous and 633 multiparous). The main data were collected prospectively, and additional data were retrieved from hospital records. The main outcome measures were exclusive breastfeeding at discharge, spontaneous suckling, and breastfeeding problems after birth. We assessed the outcomes in four groups categorized by intrapartum opioid exposure: none, IV fentanyl, EDA fentanyl and IV+EDA fentanyl. We also analyzed the dose-response relation of fentanyl administered by epidural or IV and early breastfeeding. Ultimately, we dichotomized the IV fentanyl group into two groups (≤200 µg and >200 µg) to further study the effect on early breastfeeding. RESULTS: The odds of non-exclusive breastfeeding were doubled with EDA fentanyl (odds ratio [OR] 2.45, 95% CI 1.34-4.48, p = 0.004) and four times higher with IV+EDA fentanyl (OR 4.20, 95% CI 2.49-7.09, p < 0.001) compared with no opioid exposure. Spontaneous suckling was negatively associated with intrapartum fentanyl use (p < 0.001) irrespective of mode of administration. When the IV fentanyl doses exceeded 200 µg compared with less than 200 µg, we found a reduction in exclusive breastfeeding (81% vs. 89%; p = 0.014) and spontaneous suckling (68% vs. 83%; p < 0.001) and an increase in breastfeeding problems (41% vs. 27%; p = 0.004). CONCLUSIONS: Fentanyl in labor is associated with breastfeeding difficulties. However, IV fentanyl in low doses (≤200 µg) seems to affect breastfeeding less than EDA fentanyl and is therefore a viable alternative when labor analgesia is needed. This could be most relevant for multiparous women, where a shorter labor is expected. More research is needed to determine the optimal dose and route of administration of fentanyl for labor analgesia.

Sexual Inactivity During the Last 4 Weeks in Long-Term Cervical Cancer Survivors: Prevalence and Associated Factors.

BACKGROUND: Most studies of cervical cancer (CC) survivors describe sexual inactivity in relation to treatment modalities, but few consider that inactivity varies with age and partner status. AIM: The aim of this study was to investigate the prevalence of sexual inactivity in long-term CC survivors according to age and partner status, and to examine cancer-related, health, demographic, and psychological factors related to sexual inactivity. METHODS: All 974 women treated for CC from 2000 through 2007 in 2 areas of Norway, who were alive and cancer-free by the end of 2013, received a mailed questionnaire. Among them, 523 delivered valid data on current sexual activity (response rate 57%). The prevalence rates of sexual inactivity in relation to age groups and partner status were compared to normative sample (NORMs). MAIN OUTCOME MEASURE: Sexual inactivity during the 4 weeks before the survey was administered. RESULTS: Median age of the sample at survey was 53 years (range 32-77) and median time since diagnosis was 11 years (range 6-15). Of the survivors aged 35-69 years, 39% (95% CI 35-44%) were sexually inactive at survey compared to 36% (95% CI 32-38%) in the NORMs. Compared with sexually active survivors, inactive ones were significantly older, more frequently had single partner status, and had less frequently been childbearing. Inactive survivors more frequently had low education, did not hold paid work at survey, had poorer self-rated health, and were more often obese. They also had higher prevalence of depression, high neuroticism, and chronic fatigue. On most cancer-related quality of life measures, sexually inactive survivors had significantly lower mean scores than sexually active ones. They significantly more often had been treated with chemotherapy and/or radiation than with conization or major surgery. In multivariable regression analysis, only older age, no prior childbearing, and single partner status remained significantly associated with sexual inactivity. CLINICAL IMPLICATIONS: Sociodemographic variables may be more relevant than clinical and cancer-related variables concerning sexual inactivity in long-term CC survivors. STRENGTHS & LIMITATIONS: Our study had a considerable sample size and used instruments with established psychometric qualities. The moderate response rates of the study and of the NORMs imply risks for selection biases. CONCLUSION: Close to 4 in 10 survivors were sexually inactive which is similar to the rate among NORMs. Demographic factors were most strongly associated with sexual inactivity. Some other significant factors are eventually amenable to treatment and should be checked by the health-care providers. Dahl AA, Bentzen AG, Fosså SD, et al. Sexual Inactivity During the Last 4 Weeks in Long-Term Cervical Cancer Survivors: Prevalence and Associated Factors. J Sex Med 2020;17:1359-1369.

Preferences for follow up in long-term survivors after cervical cancer.

INTRODUCTION: An increasing number of cervical cancer survivors combined with lack of data on the efficacy of long-term surveillance, challenges existing follow-up models. However, before introducing new follow-up models, cervical cancer survivors' own views on follow up are important. We aimed to explore preferences for follow up in long-term cervical cancer survivors and their associations with self-reported late-effects. MATERIAL AND METHODS: In 2013, we mailed 974 Norwegian long-term cervical cancer survivors treated during 2000-2007 a questionnaire with items covering preferences for follow up after treatment, clinical variables and validated questionnaires covering anxiety, neuroticism and depression. RESULTS: We included 471 cervical cancer survivors (response rate 57%) with a median follow up of 11 years. In all, 77% had FIGO stage I disease, and 35% were attending a follow-up program at the time of survey. Of the patients, 55% preferred more than 5 years of follow up. This was also preferred by 57% of cervical cancer survivors who were treated with conization only. In multivariable analyses, chemo-radiotherapy or surgery with radiation and/or chemotherapy (heavy treatment) and younger age were significantly associated with a preference for more than 5 years' follow up. Late effects were reported by more than 70% of the cervical cancer survivors who had undergone heavy treatment. CONCLUSIONS: Our study reveals the need for targeted patient education about the benefits and limitations of follow up. To meet increasing costs of cancer care, individualized follow-up procedures adjusted to risk of recurrence and late-effects in cervical cancer survivors are warranted.

Associations between menopausal hormone therapy and sleep disturbance in women during the menopausal transition and post-menopause: data from the Norwegian prescription database and the HUNT study.

BACKGROUND: Impaired sleep is common in menopausal women. The aim was to examine associations between uses of systemic menopausal hormone therapy (MHT) and sleep disturbance in a large population sample. METHODS: Female participants aged 45 to 75 years were selected from the Norwegian Health Study in Nord-Trøndelag (HUNT3, 2006-2008) (N = 13,060). Data were linked to the Norwegian Prescription Database, identifying use of prescribed MHT and use of sleep medication. Data were analyzed using multiple linear regression. RESULTS: In total, 996 women used systemic MHT (7.6%), with the highest prevalence of 10.3% among women 55 to 64 years of age. Despite high reports of frequent nocturnal awakening (24.7%) and high reports of hot flashes, use of MHT was low in this large population based survey. Although MHT use was associated with more sleep disturbance in unadjusted analyses, the association was not significant after adjusting for relevant covariates. Using sleep medication, reporting poor health, tobacco and alcohol use, doing daily exercise, having higher levels of anxiety, and being less satisfied with life were factors showing the strongest associations with sleep disturbance. CONCLUSION: The lack of association between MHT and sleep disturbance suggests that other factors, such as self-perceived good health, a healthy lifestyle and anxiety/depression, are more relevant to sleep than MHT.

Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire.

BACKROUND: The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used. METHODS: We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors. RESULTS: We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment. CONCLUSIONS: Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment.

Symptom Experience and Self-rated Physical Functioning in Patients With Ovarian Cancer Receiving Chemotherapy: A Longitudinal Study.

OBJECTIVES: In this longitudinal study, we investigated occurrence of multiple symptoms during chemotherapy in patients with ovarian cancer. We also evaluated whether self-rated physical functioning, selected demographic, and clinical variables were associated with symptom burden over time. METHODS AND MATERIALS: In total, 82 patients provided longitudinal data (4 time points) by completing questionnaires including the Memorial Symptom Assessment Scale, the Karnofsky Performance Status Scale, and the Self-Administered Comorbidity Questionnaire. Demographic and clinical data were collected from medical records. Karnofsky Performance Status Scale score of less than 80 was defined as low and Karnofsky Performance Status Scale score 80 or higher as high physical functioning. Possible associations between the most frequent symptoms and selected variables were modeled using binary logistic regression for repeated measures. RESULTS: Palliative treatment was the main reason for treatment for 85% of the patients. Sixty percent of the patients reported high prevalence of symptoms, particularly lack of energy, difficulty sleeping, and worrying. The total number of symptoms increased during the treatment and returned to enrollment values at 6 months. This trend was dominated with physical symptoms. When we compared women with low (n = 33) versus high physical functioning (n = 49) at enrollment, low physical functioning was significantly associated with more symptoms and distress for the study period. Patients with low physical functioning were more likely to experience lack of energy (odds ratio [OR] = 8.33), feeling drowsy (OR = 4.17), feeling bloated (OR = 2.44), feeling sad (OR = 3.33), having pain (OR = 4.72), and worrying (OR = 2.50), and this remained stable throughout the observation period of 6 months. CONCLUSIONS: A high symptom burden was reported in this cohort of patients with ovarian cancer mainly treated with palliative intent. Low self-rated physical functioning was strongly associated with high symptom burden for the 6-month period. When chemotherapy is discussed with patients with ovarian cancer with low physical functioning, possible palliation benefits must be weighed against the added risk of long-term distressful symptoms that chemotherapy implies.

Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review.

OBJECTIVES: Vulva cancer (VC) treatment carries a high risk of severe late effects that may have a negative impact on quality of life (QoL). Patient-reported outcome measures (PROMs) are increasingly used when evaluating disease- and treatment-specific effects. However, the adequacy of measures used to assess sequelae and QoL in VC remains unclear. The aims of the present study were to evaluate disease- and treatment-related effects as measured by PROMs in VC patients and to identify available VC-specific PROMs. METHODS/MATERIALS: A systematic literature search from 1990 to 2016 was performed. The inclusion criterion was report of disease- and treatment-related effects in VC patients using PROMs in the assessment. Methodological and reporting quality was in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. This systematic review was performed as part of phase 1 of the development of a European Organisation for Research and Treatment of Cancer QoL questionnaire for VC patients. RESULTS: The search revealed 2299 relevant hits, with 11 articles extracted including a total of 535 women with VC; no randomized controlled trials were identified. The selected studies exhibited great heterogeneity in terms of PROMs use. Twenty-one different instruments assessed QoL. Most of the questionnaires were generic. Different issues (sexuality, lymphedema, body image, urinary and bowel function, vulva-specific symptoms) were reported as potentially important, but the results were not systematically collected. Only one VC-specific questionnaire was identified but did not allow for assessment and reporting on a scale level. CONCLUSIONS: Vulva cancer treatment is associated with considerable morbidity deteriorating QoL. To date, there is no validated PROM available that provides adequate coverage of VC-related issues. The study confirms the need for a VC-specific QoL instrument with sensitive scales that allows for broad cross-cultural application for use in clinical trials.

Gynecological cancer patients' attitudes toward follow-up care after cancer treatment: Do preferences reflect patients' experience? A cross-sectional questionnaire study.

INTRODUCTION: Due to an increasing number of cancer patients, new follow-up models are being debated, among them follow-up by general practitioners. Before changing surveillance, it is important to explore patients' views. The purpose of this study was to compare attitudes toward follow-up care among patients treated for gynecological cancer who had not yet started a follow-up regimen, with those who had been attending a hospital-based follow-up regimen for more than one year. MATERIAL AND METHODS: We conducted a cross-sectional survey among gynecological cancer patients recruited from three Norwegian hospitals in 2013-2015: Sørlandet Hospital Kristiansand, Sørlandet Hospital Arendal and St. Olavs Hospital, Trondheim. RESULTS: In all, 239 patients agreed to participate, 100 who had not yet started follow-up and 139 who had been attending more than one year of follow-up. Patients reported that they preferred to be followed up by a gynecologist rather than by their GP, whom they viewed as less competent for this purpose. However, patients who had not yet started follow-up were more willing to be followed up by a GP. Overall, patients rated detection of recurrence as the most important aspect of follow-up visits. CONCLUSIONS: The gynecological cancer patients in our study preferred a hospital-based follow-up model. However, patients who had not yet started follow-up were more willing to be followed up by a GP. If follow-up is to be provided by GPs for selected patients, it is important that these patients are informed early of the value and limitations of follow-up visits, to ensure that they feel safe.

How does a lifestyle intervention during pregnancy influence perceived barriers to leisure-time physical activity? The Norwegian fit for delivery study, a randomized controlled trial.

BACKGROUND: To develop effective health promotional and preventive prenatal programs, it is important to understand perceived barriers to leisure-time physical activity during pregnancy, including exercise and sport participation. The aims of the present study was 1) to assess the effect of prenatal lifestyle intervention on the perceived barrier to leisure-time physical activity during pregnancy and the first year after delivery and 2) identify the most important perceived barriers to leisure-time physical activity at multiple time points during and after pregnancy. METHODS: This secondary analysis was part of the Norwegian Fit for Delivery study, a combined lifestyle intervention evaluated in a blinded, randomized controlled trial. Healthy, nulliparous women with singleton pregnancy of ≤20 gestational weeks, age ≥ 18 years and body mass index ≥19 kg/m2 were recruited via healthcare clinics in southern Norway, including urban and rural settings. Participants were randomized to either twice-weekly supervised exercise sessions and nutritional counselling (n = 303) or standard prenatal care (n = 303). The principal analysis was based on the participants who completed the standardized questionnaire assessing their perceived barriers to leisure-time physical activity at inclusion (gestational week 16, n = 589) and following intervention (gestational week 36, n = 509), as well as six months (n = 470) and 12 months (n = 424) postpartum. RESULTS: Following intervention (gestation week 35.4 ± 1.0), a significant between-group difference in perceived barriers to leisure-time physical activity was found with respect to time constraints: "... I do not have the time" (intervention: 22 vs. control: 38, p = 0.030), mother-child safety concerns: "... afraid to harm the baby" (intervention: 8 vs. control: 25, p = 0.002) and self-efficacy: "... I do not believe/think that I can do it" (intervention: 3 vs. control: 10, p = 0.050). No positive effect was seen at postpartum follow-up. Intrapersonal factors (lack of time, energy and interest) were the most frequently perceived barriers, and consistent over time among all participants. CONCLUSION: The intervention had effect on intrapersonal perceived barriers in pregnancy, but not in the postpartum period. Perceived barriers to leisure-time physical activity were similar from early pregnancy to 12 months postpartum. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01001689 , registered July 2, 2009.

What is the effect of physical activity on duration and mode of delivery? Secondary analysis from the Norwegian Fit for Delivery trial.

INTRODUCTION: The beneficial effects of physical activity during pregnancy for the mother and offspring have been reported by several studies but there are conflicting results concerning the possible effect of physical activity on the course of labor and risk of cesarean delivery. This study presents secondary analyses from the Norwegian Fit for Delivery randomized controlled trial, aiming at studying the effect of a lifestyle intervention including group exercise classes, as well as the possible influence of physical activity level in late pregnancy, on labor outcomes. MATERIAL AND METHODS: Healthy nulliparous women with singleton pregnancy were randomized to an intervention group, n = 303 (dietary counseling and twice-weekly exercise classes) or a control group, n = 303 (standard care). The participants were analyzed both by randomization and as a cohort comparing women with lowest (quartile 1, 0 metabolic equivalent of task-hours moderate-to-vigorous physical activity/week) (n = 140) vs. highest (quartile 4, ≥16 metabolic equivalent of task-hours moderate-to-vigorous physical activity/week) (n = 131) physical activity level in late pregnancy, assessed with the International Physical Activity Questionnaire. RESULT: The intervention group had a longer first stage of labor compared with the control group (293 ± 202 min vs. 257 ± 181 min, p = 0.030). No differences between the randomization groups were seen for time spent in second stage of labor, prolonged labor or mode of delivery. In the total sample, women with the highest physical activity level had lower odds ratio (OR) of acute cesarean delivery (OR 0.33, 95% CI 0.11-0.97, p = 0.044) than did those with the lowest physical activity-level. CONCLUSION: A significantly longer first stage of labor was observed in the intervention group than in the control group. A high physical activity level in late pregnancy was associated with lower odds of acute cesarean delivery compared with a low physical activity level.