Patient-initiated follow-up in women with early-stage endometrial cancer: A long-term follow-up of the OPAL trial.

OBJECTIVE: A long-term follow-up of the OPAL trial to compare the effect of patient-initiated (PIFU) versus hospital-based (HBFU) follow-up on fear of cancer recurrence (FCR), quality of life (QoL) and healthcare use after 34 months of follow-up. DESIGN: Pragmatic, multicentre randomised trial. SETTING: Four Danish departments of gynaecology between May 2013 and May 2016. POPULATION: 212 women diagnosed with stage I low-intermediate risk endometrial carcinoma. METHODS: The control group attended HBFU with regular outpatient visits (i.e., 8) for 3 years after primary treatment. The intervention group underwent PIFU with no prescheduled visits but with instructions about alarm symptoms and options of self-referral. MAIN OUTCOME MEASURES: The endpoints were FCR as measured by the Fear of Cancer Recurrence Inventory (FCRI) and QoL as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire C-30 (EORTC QLQ C-30), and healthcare use as measured by questionnaires and chart reviews after 34 months of follow-up. RESULTS: FCR decreased from baseline to 34 months in both groups and no difference was found between allocations (difference -6.31 [95% confidence interval -14.24 to 1.63]). QoL remained stable with no difference in any domains between the two arms at 34 months using a linear mixed model analysis. The use of healthcare was significantly lower in the PIFU group (P < 0.01). CONCLUSION: Patient-initiated follow-up is a valid alternative to hospital-based follow-up for people who have been treated for endometrial cancer and have low risk of recurrence.

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.

How Do We Follow Up Patients With Endometrial Cancer?

PURPOSE OF REVIEW: In this review, we present the existing evidence regarding follow-up care after endometrial cancer, including content of follow-up and type of provider. We furthermore discuss the future perspectives for follow-up care and research in the field. RECENT FINDINGS: Recently published randomized controlled trials show that nurse-led telephone follow-up and patient-initiated follow-up are feasible alternatives to routine hospital-based follow-up. No randomized or prospective study has evaluated the effect of routine follow-up on survival. Hence, current knowledge is derived from retrospective studies with the inherent risk of bias. The most important method for recurrence detection is a review of symptoms. There is no evidence to support a survival benefit from the use of routine physical examinations, additional tests, or imaging. One in three of the women attending hospital-based follow-up experience unmet needs, and alternative models for follow-up focused on survivorship care and empowerment should be tested.

Initial validation of the Danish version of the Fear of Cancer Recurrence Inventory (FCRI) in colorectal cancer patients.

PURPOSE: The Fear of Cancer Recurrence Inventory (FCRI) is a multidimensional measure for fear of cancer recurrence (FCR). The aim of this study was to assess the psychometric properties of the translated Danish version of the FCRI in a population of colorectal cancer patients. METHODS: The English version of the FCRI was forward-backward translated into Danish and pilot tested in a gynaecological cancer population. The psychometric properties of the FCRI were assessed in terms of responsiveness, test-retest reliability and discriminative and convergent validity in a population of colorectal cancer patients by asking them to complete questionnaires at three time points during follow-up. Clinical FCR was defined as ≥ 16 at the FCRI short form. RESULTS: The participation rate was 57%. A low association was found between higher scores on the FCRI and younger age (r = - 0.29, p = 0.02). A moderate correlation was found between the FCRI score and a measure for worry traits (r = 0.49, p < 0.001). Mean difference in total FCRI score was statistically significant between 'pre-scan' and 'postscan' (p < 0.001), thus indicating that the FCRI was responsive to change. The FCRI score showed good test-retest reliability (intraclass correlation = 0.84). CONCLUSION: The Danish version of the FCRI is a reliable and responsive measure for FCR in colorectal cancer patients and shows acceptable discriminative and convergent validity. IMPLICATIONS FOR CANCER SURVIVORS: A valid measure for FCR is crucial in order to identify patients with a need for special attention or interventions for high levels of FCR and to improve future research into FCR among cancer survivors.

Risk of recurrence, prognosis, and follow-up for Danish women with cervical cancer in 2005-2013: A national cohort study.

BACKGROUND: In developed countries, women attend follow-up after treatment for cervical cancer to detect recurrence. The aim of this study was to describe the Danish population of women with early-stage cervical cancer at risk for recurrence and death due to recurrence. METHODS: Data were extracted from 3 nationwide databases to find women diagnosed with stage 1A1 to 1B1 cervical cancer in 2005-2013. Recurrences were determined from data on oncological or surgical treatment more than 3 months after the initial diagnosis and were cross-checked with patient journals. RESULTS: In all, 1523 patients were diagnosed with stage 1A1 to 1B1 cervical cancer. Eighty women experienced recurrences: 8 at International Federation of Gynecology and Obstetrics (FIGO) stage 1A1, 0 at FIGO stage 1A2, and 72 at FIGO stage 1B1. The 5-year recurrence rate was 6.4%; 67.5% of the women had symptomatic recurrences, and 28.8% had asymptomatic recurrences. At significantly greater risk for recurrence were women at stage 1B1, regardless of their lymph node (LN) status at diagnosis (hazard ratio with a positive LN, 5.10; 95% confidence interval [CI], 1.65-15.76; P = .0047; hazard ratio with a negative LN, 3.14; 95% CI, 1.25-7.93; P = .0153; hazard ratio with LN data missing, 6.33; 95% CI, 1.80-22.26; P = .004), women older than 50 years (hazard ratio, 1.81; 95% CI, 1.12-2.94; P = .0158), and women with lymphatic and lymphovascular space invasion (LVSI; hazard ratio, 1.92; 95% CI, 1.11-3.30; P = .0188). In a multivariate analysis, significantly inferior survival was found after recurrence for patients with lymphatic LVSI (hazard ratio, 2.23; 95% CI, 1.04-4.80; P = .0401), a symptomatic diagnosis of recurrence (hazard ratio, 2.52; 95% CI, 1.08-5.90; P = .0332), and multiple sites of recurrence (hazard ratio, 2.72; 95% CI, 1.32-5.61; P = .0066). CONCLUSIONS: This study has identified a group of women at FIGO stage 1A1 in no need of specialized, hospital-based follow-up. Many of the recurrences at FIGO stage 1B1 are asymptomatic, and this may show a need for follow-up in this group. Further prospective investigation is needed. Cancer 2018;124:943-51. © 2017 American Cancer Society.

The impact of the survivorship care plan on health care use: 2-year follow-up results of the ROGY care trial.

PURPOSE: The purpose of this paper was to assess the impact of survivorship care plan (SCP) provision and moderating factors on health care use following endometrial cancer treatment. METHODS: Women newly diagnosed with endometrial cancer were included in a pragmatic cluster randomized trial at 12 hospitals in the Netherlands and were randomly assigned to SCP or usual care (n = 221; 75% response). The SCP was generated using the web-based Registrationsystem Oncological GYnecology (ROGY) and provided tailored information regarding disease, treatment, and possible late-effects. Cancer-related use of general practitioner, specialist, and additional health care was collected through questionnaires after diagnosis and at 6-, 12-, and 24-month follow-up and compared using linear multilevel regression analyses. RESULTS: Women who received an SCP had more cancer-related primary care visits compared to the usual care arm during the first year after diagnosis (ß = 0.7, p < 0.01). At 6-month follow-up, women in the SCP group used more additional health care compared to women receiving usual care (24 vs. 11%, p = 0.04). Women with anxious symptoms (p = 0.03) and women who received radiotherapy (p = 0.01) had a higher primary care use within the first year after treatment, when receiving an SCP. CONCLUSIONS: The SCP increases primary health care consumption the first year after treatment, particularly in women treated with radiotherapy and women with anxious symptoms. IMPLICATIONS FOR CANCER SURVIVORS: These findings imply that the SCP enables women in need of supportive care to seek relevant care at an early stage after treatment. Whether this results in improved patient-reported outcomes in the long-term needs to be further studied.

Detection of recurrence in early stage endometrial cancer - the role of symptoms and routine follow-up.

BACKGROUND: Considerable controversy remains as to the optimal organization of endometrial cancer follow-up. AIM: To evaluate the relationship between the way recurrence was detected and survival after treatment for endometrial cancer. Further, to identify characteristics associated with a pre-scheduled examination in women with symptomatic recurrence. MATERIAL AND METHODS: All women with early stage endometrial cancer during 2005-2009 were included in a population-based historical cohort derived from the Danish Gynecological Cancer Database. Women diagnosed with recurrence within three years after primary surgery and the mode of recurrence detection were identified from hospital charts: asymptomatic recurrence detected at regular follow-up, symptomatic recurrence detected at regular follow-up or symptomatic recurrence detected in between follow-up. Survival of women with symptomatic and asymptomatic disease was compared. Furthermore, characteristics associated with self-referral as compared to presenting symptoms at regular follow-ups were identified using univariate analyses. RESULTS: In total, 183 cases of recurrence (7%) were identified in the cohort of 2612 women. Of these, 65.5% were symptomatic with vaginal bleeding as the most prevalent symptom. Asymptomatic women had a significantly better three-year survival rate compared to symptomatic women (80.3% vs. 54.3%, p < 0.01). A total of 2.3% of the entire population had an asymptomatic recurrence. Women diagnosed at a pre-scheduled visit due to symptoms had a higher educational level (p = 0.03) and more often high-risk disease (p = 0.02) than symptomatic women diagnosed at regular follow-up. CONCLUSION: Early stage endometrial cancer carries a low risk of recurrence. Survival appears to be superior in asymptomatic patients, but length-time bias, i.e. the effect of aggressive tumor biology in symptomatic recurrences, may bias results in non-randomized controlled trials. Well educated patients with symptoms of recurrence more often sought medical attendance compared to less educated counterparts. This should be considered if patient-initiated follow-up is the standard care.

The nature of early-stage endometrial cancer recurrence-A national cohort study.

BACKGROUND AND AIMS: The aim of the study was to present a comprehensive analysis of disease recurrence in a large Danish cohort of women with early-stage endometrial cancer treated according to national guidelines. METHODS: All women diagnosed with stage I or II endometrial cancer in 2005-2009 were included in a population-based historical cohort derived from the Danish Gynaecological Cancer Database. Disease recurrence up to 3 years after the primary diagnosis was identified using national registers and hospital charts. Follow-up on survival ended on 31st December 2014. We evaluated the predictive value of clinico-pathological and sociodemographic variables using multivariate logistic regression. RESULTS: Recurrence within 3 years of the primary treatment was diagnosed in 183 (7%) of the included 2612 women. Site of recurrence significantly impacted on overall survival as the 5-year survival rate was 64.8% for women with vaginal recurrence and 17.5% in women with distant recurrence. Factors predictive of recurrence included the International Federation of Gynaecology and Obstetrics (FIGO) stage (OR: IB = 1.91, stage II = 3.91), Charlson comorbidity index of 3 (OR 1.86), non-endometrioid histology (OR 1.81) and being outside of the workforce (OR 1.81). Vaginal recurrence was predicted by FIGO stage only (OR: IB = 1.88, II = 2.79), while extra-vaginal recurrence was predicted by FIGO stage (OR: IB = 2.12, II = 3.31), Charlson comorbidity index of 3 (OR 1.88) and non-endometrioid histology (OR 2.51). CONCLUSIONS: Future research should seek to understand the underlying mechanisms of the identified predictive factors to improve recurrence prediction and to reduce morbidity and mortality.

Needs and priorities of women with endometrial and cervical cancer.

INTRODUCTION: Rehabilitation after cancer is important, and efficient rehabilitation requires knowledge of patient's needs. This study aimed to identify short-term rehabilitation needs of women with endometrial and cervical cancer. METHODS: Ninety-six women (82.6%) were included in an exploratory questionnaire study from Odense University Hospital from September 2011 to March 2012. Needs were assessed pre-treatment and 3 months later using the three-levels-of-needs questionnaire. Furthermore, 16 women participated in focus group interviews following the treatment. The interviews were audio-recorded, transcribed verbatim and analyzed thematically. RESULTS: Forty-four of the included women were diagnosed with cervical cancer (median age 45 years). Of these, 22 had FIGO-stage 1 disease (50%) and 23 received radiation therapy (52.3%). The remaining 52 women (median age 66.5 years) were diagnosed with endometrial cancer. Of these, 38 had FIGO-stage 1 disease (73.1%) and 25 were treated with laparoscopic surgery (48.1%). Emotional functioning was significantly worse prior to treatment in both the cancers (p < 0.001 cervical and p = 0.002 endometrial) and worry constituted an unmet need in 70.7% of cervical and 34.7% of endometrial cancer patients. Both the patient groups experienced significant lymphedema post-treatment [endometrial cancer (p = 0.006) and cervical cancer (p = 0.002)]. Further, urological problems were more prevalent post-treatment in endometrial cancer patients (p = 0.018), while sexual problems were of specific concern for cervical cancer patients (p = 0.029). However, in both cancer groups, the mean problem intensity scores were comparable to normative data, suggesting that the majority of patients will not require extensive rehabilitation. Qualitative analysis indicated that treatment modality and marital status severely impacted on coping, suggesting that irradiated and single women are at higher risk of developing rehabilitation needs. Additionally, women younger than 55 years more often requested help dealing with sexual and psychological complications. DISCUSSION: Women with endometrial and cervical cancer experience emotional problems prior to therapy and lymphedema, and urological and sexual problems following treatment. An awareness of these problems may facilitate early identification of women with unmet needs and enable individualized follow-up adjusted for such patient's needs. Interventions aimed at improving sexual and psychological functioning should be available.