Nurse-Led Individualized Follow-Up Versus Regular Physician-Led Visits After Early Breast Cancer (MyHealth): A Phase III Randomized, Controlled Trial.

PURPOSE: Follow-up after breast cancer with regular visits has failed to detect recurrences, be cost-effective, and address patient needs. METHODS: MyHealth is a phase III randomized controlled trial (ClinicalTrials.gov identifier: NCT02949167). Patients, who recently completed primary treatment for stage I-II breast cancer, were randomly assigned in variable block sizes and stratified by age and human epidermal growth factor receptor 2 status to intervention or control follow-up. The nurse-led intervention comprised three to five individual self-management sessions, regular reporting of symptoms, and navigation to health care services. The control follow-up comprised regular outpatient visits with the physician. The primary outcome was breast cancer-specific quality of life (QoL) measured by the Trial Outcome Index-Physical/Functional/Breast summary score of the Functional Assessment of Cancer Therapy-Breast 2 years after random assignment. Secondary outcomes were fear of recurrence, anxiety, depression, and health care utilization. Analyses were intention-to-treat and P values were two-sided with 95% confidence level set at 0.005 because of multiple comparisons. RESULTS: Among 1,101 eligible patients, 875 were invited and 503 were randomly assigned to control (n = 252) or intervention (n = 251) follow-up. At 2 years, patients in the intervention group reported a significantly and clinically relevant higher QoL (mean, 75.69 [standard deviation [SD], 12.27]) than patients in the control group (71.26 [SD, 14.08]), with a mean difference of 5.05 (95% CI, 3.30 to 6.79; P < .001). The intervention group reported significantly less fear of recurrence, anxiety, and depression; they had fewer physician consultations but more nurse contacts and an unchanged diagnostic imaging pattern. The effect on all outcomes was stable through a 3-year follow-up. CONCLUSION: The MyHealth study suggested a new strategy for follow-up after early breast cancer as it provided significant improvements in QoL.

The association between education and fear of recurrence among breast cancer patients in follow-up - and the mediating effect of self-efficacy.

BACKGROUND: Major restructuring of surveillance after breast cancer treatment with less follow-up consultations may result in insecurity and fear of recurrence (FCR) among the less resourceful breast cancer patients. We investigate the association between breast cancer patients' education and FCR and if self-efficacy mediates the associations between education and FCR. MATERIAL AND METHODS: A questionnaire survey was conducted from 2017 to 2019, among 1773 breast cancer patients shortly after having their follow-up switched from regular outpatient visits with an oncologist to either nurse-led or patient-initiated follow-up, with a subsequent questionnaire after 12 months. Data on disease and treatment characteristics were extracted from medical records and the Danish Breast Cancer Group Database. Logistic regression analyses were used to examine the association between education and FCR. Separate analyses were conducted for patients ≤ and >5 years since diagnosis and all models were adjusted for age and cohabitation status. To explore potential mediation by self-efficacy, we conducted regression analyses on education and FCR further adjusting for self-efficacy. RESULTS: The participation rate was 57%, and after the exclusion of patients due to missing data, 917 were included in analyses. Patients with long education had significantly less FCR compared to patients with short education (OR (95% CI) 0.71 (0.51;0,99)). When separated by time since diagnosis, there was no association among patients >5 years since diagnosis while the OR was 0.51 (95% CI, 0.30;0.85) for patients ≤5 years since diagnosis. Further adjusting for self-efficacy among patients <5 years since diagnosis resulted in an OR of 0.56 (95% CI, 0.33;0.95) among patients with long compared to short education. CONCLUSION: Up to 5 years after diagnosis, breast cancer patients with long education are less likely to experience FCR than patients with short education. Self-efficacy mediated only a very small part of this association, indicating that other factors play a role in socioeconomic differences in FCR among breast cancer patients.

Effects on long-term survival of psychosocial group intervention in early-stage breast cancer: follow-up of a randomized controlled trial.

BACKGROUND: The promise of prolonged survival after psychosocial interventions has long been studied, but not convincingly demonstrated. This study aims to investigate whether a psychosocial group intervention improved long-term survival in women with early-stage breast cancer and investigate differences in baseline characteristics and survival between study participants and non-participants. METHODS: A total of 201 patients were randomized to two six-hour psychoeducation sessions and eight weekly sessions of group psychotherapy or care as usual. Additionally, 151 eligible patients declined to participate. Eligible patients were diagnosed and treated at Herlev Hospital, Denmark, and followed for vital status up to 18 years after their primary surgical treatment. Cox's proportional hazard regressions were used to estimate hazard ratios (HRs) for survival. RESULTS: The intervention did not significantly improve survival in the intervention group compared with the control group (HR, 0.68; 95% confidence interval (CI), 0.41-1.14). Participants and non-participants differed significantly in age, cancer stage, adjuvant chemotherapy, and crude survival. When adjusted, no significant survival difference between participants and non-participants remained (HR, 0.77; 95% CI, 0.53-1.11). CONCLUSIONS: We could not show improved long-term survival after the psychosocial intervention. Participants survived longer than nonparticipants, but clinical and demographic characteristics, rather than study participation, seem accountable for this difference.

Are education and cohabitation associated with health-related quality of life and self-management during breast cancer follow-up? A longitudinal study.

BACKGROUND: Oncologist-led follow-up after breast cancer (BC) is increasingly replaced with less intensive follow-up based on higher self-management, which may overburden the less resourceful patients. We examined whether socioeconomic factors measured recently after the implementation of a new follow-up program for BC patients were associated with health-related quality of life (HRQoL) and self-management 12 months later. METHODOLOGY: Between January and August 2017, we invited 1773 patients in Region Zealand, Denmark, to participate in baseline and 12 months follow-up questionnaires. The patients had surgery for low- and intermediate risk BC 1-10 years prior to the survey, and they had recently been allocated to the new follow-up program of either patient-initiated follow-up, or in-person or telephone follow-up with a nurse, based on patients' preferences. We examined associations between socioeconomic factors (education and cohabitation) at baseline and two outcomes: HRQoL (EORTC QLQ-C30 and QLQ-BR23) and self-management factors (health care provider, confidence in follow-up, contact at symptoms of concern, and self-efficacy) at 12 months follow-up. Sensitivity analyses were performed according to time since diagnosis (≤ 5 > 5 years). Furthermore, we investigated whether treatment and self-management factors modified the associations. RESULTS: A total of 987 patients were included in the analyses. We found no statistically significant associations between socioeconomic factors and HRQoL, except in patients ≤ 5 years from diagnosis. For self-management patients with short education were more likely to report that they had not experience relevant symptoms of concern compared to those with medium/long education (OR 1.75 95% CI: 1.04; 2.95). We found no clear patterns indicating that treatment or self-management factors modified the associations between socioeconomics' and HRQoL. CONCLUSION: Overall socioeconomic factors did not influence HRQoL and self-management factors except for experiencing and reporting relevant symptoms of concern. Socioeconomic factors may, however, influence HRQoL in patients within five years of diagnosis.

Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners: Results From the Randomized ProCan Trial.

INTRODUCTION: Patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience impaired sexual and urinary function. AIM: To compare the effect of early couple counseling and pelvic floor muscle training (PFMT) with usual care for sexual and urinary dysfunction after RP. METHODS: The ProCan study was a randomized controlled trial (RCT) with two parallel treatment arms and 1:1 allocation. Between January 2016 and December 2017, candidates for RP were invited to a longitudinal questionnaire study and provided baseline measures before surgery. Patients who underwent RP, had a female partner, and were sexually active were invited to the ProCan RCT. Couples who provided informed consent were allocated to usual care or usual care and up to six couple counseling sessions, up to three instructions in PFMT and a video home-training program. All couples filled in follow-up questionnaires at 8 and 12 months and non-participants provided 12 months' follow-up. Linear mixed-effect models and 95% confidence intervals were used to measure effects of the intervention. MAIN OUTCOME MEASURE: Primary outcome was erectile function, measured with The International Index of Erectile Function, at 8 and 12 months follow-up. Secondary outcomes were sexual and urinary function and use of treatment for erectile dysfunction (ED) by patients; sexual function in female partners; and relationship function, health-related quality of life, anxiety, depression, and self-efficacy in both patients and female partners. RESULTS: Thirty-five couples were randomized. No significant effect of the intervention was found on erectile function at 8 months (estimated difference in change, 1.41; 95% CI; -5.51 ; 8.33) or 12 months (estimated difference in change, 0.53; 95% CI; -5.94; 6.99) or in secondary outcomes, except for significantly increased use of ED treatment at 8 months. CONCLUSION: We found no effect of early couple counseling and PFMT, possibly because of the limited number of participants. Karlsen RV, Bidstrup PE, Giraldi A, et al. Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners. Results From the Randomized ProCan Trial. Sex Med 2021;9:100350.

Follow-up strategies following completion of primary cancer treatment in adult cancer survivors.

BACKGROUND: Most cancer survivors receive follow-up care after completion of treatment with the primary aim of detecting recurrence. Traditional follow-up consisting of fixed visits to a cancer specialist for examinations and tests are expensive and may be burdensome for the patient. Follow-up strategies involving non-specialist care providers, different intensity of procedures, or addition of survivorship care packages have been developed and tested, however their effectiveness remains unclear. OBJECTIVES: The objective of this review is to compare the effect of different follow-up strategies in adult cancer survivors, following completion of primary cancer treatment, on the primary outcomes of overall survival and time to detection of recurrence. Secondary outcomes are health-related quality of life, anxiety (including fear of recurrence), depression and cost. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, four other databases and two trials registries on 11 December 2018 together with reference checking, citation searching and contact with study authors to identify additional studies. SELECTION CRITERIA: We included all randomised trials comparing different follow-up strategies for adult cancer survivors following completion of curatively-intended primary cancer treatment, which included at least one of the outcomes listed above. We compared the effectiveness of: 1) non-specialist-led follow-up (i.e. general practitioner (GP)-led, nurse-led, patient-initiated or shared care) versus specialist-led follow-up; 2) less intensive versus more intensive follow-up (based on clinical visits, examinations and diagnostic procedures) and 3) follow-up integrating additional care components relevant for detection of recurrence (e.g. patient symptom education or monitoring, or survivorship care plans) versus usual care. DATA COLLECTION AND ANALYSIS: We used the standard methodological guidelines by Cochrane and Cochrane Effective Practice and Organisation of Care (EPOC). We assessed the certainty of the evidence using the GRADE approach. For each comparison, we present synthesised findings for overall survival and time to detection of recurrence as hazard ratios (HR) and for health-related quality of life, anxiety and depression as mean differences (MD), with 95% confidence intervals (CI). When meta-analysis was not possible, we reported the results from individual studies. For survival and recurrence, we used meta-regression analysis where possible to investigate whether the effects varied with regards to cancer site, publication year and study quality. MAIN RESULTS: We included 53 trials involving 20,832 participants across 12 cancer sites and 15 countries, mainly in Europe, North America and Australia. All the studies were carried out in either a hospital or general practice setting. Seventeen studies compared non-specialist-led follow-up with specialist-led follow-up, 24 studies compared intensity of follow-up and 12 studies compared patient symptom education or monitoring, or survivorship care plans with usual care. Risk of bias was generally low or unclear in most of the studies, with a higher risk of bias in the smaller trials. Non-specialist-led follow-up compared with specialist-led follow-up It is uncertain how this strategy affects overall survival (HR 1.21, 95% CI 0.68 to 2.15; 2 studies; 603 participants), time to detection of recurrence (4 studies, 1691 participants) or cost (8 studies, 1756 participants) because the certainty of the evidence is very low. Non-specialist- versus specialist-led follow up may make little or no difference to health-related quality of life at 12 months (MD 1.06, 95% CI -1.83 to 3.95; 4 studies; 605 participants; low-certainty evidence); and probably makes little or no difference to anxiety at 12 months (MD -0.03, 95% CI -0.73 to 0.67; 5 studies; 1266 participants; moderate-certainty evidence). We are more certain that it has little or no effect on depression at 12 months (MD 0.03, 95% CI -0.35 to 0.42; 5 studies; 1266 participants; high-certainty evidence). Less intensive follow-up compared with more intensive follow-up Less intensive versus more intensive follow-up may make little or no difference to overall survival (HR 1.05, 95% CI 0.96 to 1.14; 13 studies; 10,726 participants; low-certainty evidence) and probably increases time to detection of recurrence (HR 0.85, 95% CI 0.79 to 0.92; 12 studies; 11,276 participants; moderate-certainty evidence). Meta-regression analysis showed little or no difference in the intervention effects by cancer site, publication year or study quality. It is uncertain whether this strategy has an effect on health-related quality of life (3 studies, 2742 participants), anxiety (1 study, 180 participants) or cost (6 studies, 1412 participants) because the certainty of evidence is very low. None of the studies reported on depression. Follow-up strategies integrating additional patient symptom education or monitoring, or survivorship care plans compared with usual care: None of the studies reported on overall survival or time to detection of recurrence. It is uncertain whether this strategy makes a difference to health-related quality of life (12 studies, 2846 participants), anxiety (1 study, 470 participants), depression (8 studies, 2351 participants) or cost (1 studies, 408 participants), as the certainty of evidence is very low. AUTHORS' CONCLUSIONS: Evidence regarding the effectiveness of the different follow-up strategies varies substantially. Less intensive follow-up may make little or no difference to overall survival but probably delays detection of recurrence. However, as we did not analyse the two outcomes together, we cannot make direct conclusions about the effect of interventions on survival after detection of recurrence. The effects of non-specialist-led follow-up on survival and detection of recurrence, and how intensity of follow-up affects health-related quality of life, anxiety and depression, are uncertain. There was little evidence for the effects of follow-up integrating additional patient symptom education/monitoring and survivorship care plans.

Do people improve health behavior after their partner is diagnosed with cancer? A prospective study in the Danish diet, Cancer and Health Cohort.

Background: The cancer diagnosis is regarded as a stressful life event that is thought to trigger a teachable moment to induce health behavior changes among cancer patients. However, this may also hold true for their partners. We assessed if partners of cancer patients make more health behavior changes compared to persons whose partner remained cancer-free. Methods: Lifestyles was assessed in the prospective Danish Diet, Cancer and Health study. Logistic regression analyses were used to assess health behavior change among partners of cancer patients (n = 672) compared to partners of persons who remained cancer-free (n = 5534). Additionally, associations in two subgroups were assessed: bereaved partners and partners of patients who remained alive after cancer. Results: Partners of cancer patients were more likely to decrease their alcohol intake compared to partners of persons who remained cancer free. This finding could mainly be attributed to bereaved partners. Moreover, bereaved partners were also more likely to decrease their BMI. In contrast to our hypothesis, bereaved partners were more likely to decrease fruit intake and increase sugared beverages compared to partners of persons who remained cancer free. In general, men tended to improve their physical activity, while women tended to worsen their physical activity following the cancer diagnosis of their partner. Conclusions: A cancer diagnosis in the partner does seem to improve health behavior change only for alcohol intake. Bereaved partners tend to worsen dietary behaviors after the patient's death.

MyHealth: specialist nurse-led follow-up in breast cancer. A randomized controlled trial - development and feasibility.

Background: Traditionally, women treated for breast cancer (BC) have been followed up through regular oncologist-led visits in outpatient clinics, focusing on detection of recurrences, new primary BC, symptom management, and psychological support. However, this follow-up routine is expensive and its effectiveness has been questioned. Consequently, alternative follow-up programs have been tested. The Guided Self-Determination method (GSD), which facilitates partnership between health-care provider and patient, has been shown to improve self-management in patients with chronic conditions, including cancer. Patient-reported outcomes (PRO) is another increasingly used tool to improve patient-provider communication, symptom monitoring and control. In combination, GSD and PRO may have the potential to meet the objectives of BC follow-up. To test this, we developed the MyHealth study, a randomized controlled trial comparing a nurse-led follow-up program based on GSD, collection of PRO, and patient navigation with routine oncologist-led follow-up. Here we describe how we developed the intervention and are currently testing the feasibility of the MyHealth protocol in terms of recruitment, adherence to the intervention, collection of PRO, and patient navigation. Material and methods: We have invited the first 25 consecutively enrolled patients to test the MyHealth intervention. This consists of (1) 3-5 initial GSD appointments with a nurse, (2) collection of PRO, and (3) symptom management and patient navigation. The randomized trial was launched in January 2017 and is still recruiting. Results of the feasibility study: Of 32 patients invited, 25 accepted participation. At 18-month follow-up, two patients have withdrawn, 143 PRO questionnaires have been completed (mean 5.7/patient) resulting in 59 nurse contacts (mean 2.4 per patient) and 14 project physician contacts (mean 0.6 per patient). Conclusion: A high recruitment rate and response rate to PRO indicate that follow-up led by specialist nurses, based on collection of PRO is feasible and acceptable for patients treated for early stage BC.

Feasibility and acceptability of couple counselling and pelvic floor muscle training after operation for prostate cancer.

BACKGROUND: Radical prostatectomy is often followed by long-lasting erectile dysfunction and urinary incontinence, with adverse effects on the quality of life and intimate relationship of patients and partners. We developed the ProCan intervention to ameliorate sexual and urological dysfunction after radical prostatectomy and examined its feasibility, acceptability and changes in sexual function. MATERIAL AND METHODS: Between May 2014 and October 2014, seven couples attending the Department of Urology, Rigshospitalet, were included 3-4 weeks after radical prostatectomy in the ProCan intervention, which consists of up to six couple counselling sessions, group instruction in pelvic floor muscle training (PFMT), up to three individual PFMT sessions and a DVD home training program. We examined its feasibility on the basis of the recruitment rate, adherence to and acceptability of the intervention, the response rate and changes in erectile and sexual functioning measured on the International Index of Erectile Function at baseline and at eight and 12 months. RESULTS: The recruitment rate was 14%. One couple withdrew, six couples attended 1-4 counselling sessions, and all patients attended PFMT until continence was achieved. The response rate on outcomes was 85% for patients and 71% for partners. The couples reported that counselling improved their sex life but it did not improve their ability to talk openly about sex. Most patients found that the physiotherapist improved their motivation and the quality and intensity of PFMT. Erectile dysfunction improved from severe at baseline to moderate at eight months' follow-up, and mean sexual functioning improved from 18.4 to 37.1 points at eight months' follow-up, but decreased slightly to 31.4 at 12 months. CONCLUSION: Our results suggest that the recruitment procedure should be adapted and minor revisions are needed in the intervention. The key components, couple counselling and PFMT, were well accepted and achievable for the patients.

Physical activity and survival in breast cancer.

PURPOSE: Knowledge about lifestyle factors possibly influencing survival after breast cancer (BC) is paramount. We examined associations between two types of postdiagnosis physical activity (PA) and overall survival after BC. PATIENTS AND METHODS: We used prospective data on 959 BC survivors from the Diet, Cancer, and Health cohort, all enrolled before diagnosis. Self-reported PA was measured as time per activity, and estimated metabolic equivalent task (MET)-hours per week were summed for each activity. We constructed measures for household, exercise, and total PA. The association between postdiagnosis PA and all-cause mortality was estimated as hazard ratio (HRs) based on Cox proportional hazards model, with time since diagnosis as the underlying time scale. Prediagnosis PA, body mass index (BMI), and receptor status were examined as potential effect modifiers. RESULTS: We identified 144 deaths from all causes during the study period. In adjusted analyses, exercise PA above eight MET h/week compared to lower levels of activity was significantly associated with improved overall survival (HR, 0.68; confidence interval [CI]: 0.47-0.99). When comparing participation in exercise to non-participation, we found a 44% risk reduction in overall survival (HR, 0.56; CI: 0.33-0.95). Neither between household nor total PA and overall survival did, we find significant associations. Prediagnosis PA, BMI, and receptor status did not modify the effect significantly. CONCLUSION: Exercise PA corresponding to 2.5 h or more of brisk weekly walking after BC diagnosis may reduce mortality by up to 32% compared to low-level exercise. Participation in exercise PA may reduce mortality by 44% compared to non-participation.

The impact of a breast cancer diagnosis on health-related quality of life. A prospective comparison among middle-aged to elderly women with and without breast cancer.

Background The improved survival after breast cancer has prompted knowledge on the effect of a breast cancer diagnosis on health-related quality of life (HQoL). This study compared changes in HQoL among women from before to after breast cancer diagnosis with longitudinal changes among women who remained breast cancer-free. Material and methods The Danish Diet, Cancer and Health study included 57 053 cancer-free persons aged 50-64 years at baseline (1993-1997). We used data from first follow-up (1999-2002) and second follow-up (2010-2012) on HQoL [Medical Outcomes Survey, short form (SF-36)] obtained from 542 women aged 64-82 years with primary breast cancer (stages I-III) and a randomly matched sample of 729 women who remained breast cancer-free. Linear regression models were used to estimate the differences in changes in HQoL between women with and without breast cancer; the analyses were repeated with stratification according to age, comorbidity, partner support and time since diagnosis. Results Women with breast cancer reported significantly larger decreases in HQoL from before to after diagnosis than those who remained breast cancer-free (physical component summary, -2.0; 95% CI -2.8; -1.2, mental component summary, -1.5, 95% CI -2.3; -0.6). This association was significantly modified by comorbidity and time since diagnosis. Conclusions Women with breast cancer reported significantly larger HQoL declines than breast cancer-free women. Breast cancer diagnosis seems to have the greatest impact on HQoL closest to diagnosis and in women with comorbidity indicating that this group should be offered timely and appropriate follow-up care to prevent HQoL declines.

PSA testing without clinical indication for prostate cancer in relation to socio-demographic and clinical characteristics in the Danish Diet, Cancer and Health Study.

BACKGROUND: Social differences in prostate cancer (PC) incidence and mortality might be related to testing for prostate-specific antigen (PSA). Although routine PSA screening is not recommended in Denmark, testing without clinical indication increased during the past decade. We evaluated associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. MATERIAL AND METHODS: In the Danish Diet, Cancer and Health Cohort, we identified 1051 men with PC diagnosed in 1993-2008. Diagnostic and clinical characteristics were obtained from medical records, and socio-demographic information was retrieved from administrative registers. We used general logistic regression analysis to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for associations between socio-demographic or clinical characteristics and PSA testing without clinical indication. Cox regression analysis was used to examine associations with mortality. RESULTS: PSA testing without clinical indication was less likely among patients > 67 years (OR 0.7; 0.5-1.0). Men who were, PSA tested without clinical indication, were more likely to have vocational training (OR 1.8; 1.1-2.9) or higher education (OR 1.5; 0.9-2.5) and less likely to have advanced disease (OR 0.6; 0.4-0.9). PSA testing without clinical indication more often preceded therapy with curative intent (OR 1.8; 1.1-2.9) and less often palliative treatment (OR 0.6; 0.3-1.0). Men who were PSA tested without clinical indication had non-significantly lower overall and PC-specific mortality [hazard ratios 0.8 (0.5-1.2) and 0.6 (0.3-1.1), respectively]. CONCLUSIONS: PSA testing without clinical indication was associated with higher educational level. PC detected by PSA testing with no clinical indication was more often localized and treated with curative intent.

No effect on survival of home psychosocial intervention in a randomized study of Danish colorectal cancer patients.

OBJECTIVE: We investigated whether regular home visits to persons with newly diagnosed colorectal cancer influenced their overall survival and selected immune parameters. METHODS: A total of 249 Danish colorectal cancer patients undergoing abdominal surgery were randomly assigned to a control or an intervention group. The intervention group received 10 home visits from a project nurse or a medical doctor during the first 2 years after discharge. The home visits aimed at providing emotional support and information. A subgroup of 55 patients provided blood samples 3, 12 and 24 months after discharge for measurement of immune parameters. Survival was assessed 6.5-9.5 years after the first operation. RESULTS: A total of 148 patients died during follow-up. The intervention was not significantly associated with survival (p=0.68) after adjustment for Dukes' stage, radicality of the operation, age, sex, family social class and marital status. Likewise, no significant interactions were found between group and these covariates (all p > or = 0.08). In the substudy of the possible effect of the intervention on immune parameters, there were no differences between the two groups with respect to lymphocyte proliferation (all p > or = 0.078) or natural killer cell activity (all p > or = 0.33) and no consistent effect on the number of specific subsets of cells (phenotypes) during follow-up. CONCLUSION: The study failed to provide evidence that the psychosocial intervention provided as home visits significantly affected the prognosis or selected immune parameters of patients who had undergone surgery for colorectal cancer.

Quality of life of Danish colorectal cancer patients with and without a stoma.

GOALS OF THE WORK: As part of a psychosocial intervention study, we wanted to prospectively assess the quality of life of colorectal cancer patients who were given a stoma at the time of their initial operation for cancer or later and those whose initial stoma was removed. MATERIALS AND METHODS: A total of 249 colorectal cancer patients were recruited and responded to a questionnaire 3, 6, 12 and 24 months after the initial operation (26-35% had a stoma during follow-up). MAIN RESULTS: Although most of the differences between stoma and non-stoma patients failed to reach significance, 22 out of 27 variables indicated a poorer quality of life for those with a stoma. Patients who currently had a stoma had significantly higher levels of depression (p = 0.013), poorer social functioning (p = 0.0085) and more problems with body image (p = 0.0001), future perspectives (p = 0.0058), micturition (p = 0.018) and side effects from chemotherapy (p = 0.008), but fewer problems with constipation (p = 0.034) than non-stoma patients. Male patients with a stoma had more sexual problems than males without a stoma (p = 0.015). Among those with a current stoma, quality of life seemed poorer among those whose stoma was made during follow-up compared with those with an initial stoma. CONCLUSIONS: Trends suggested that having a stoma led to poorer scores in most aspects of quality of life and that having a stoma made some time after the initial operation was more distressing than having a stoma made during the primary cancer operation.

A randomized psychosocial intervention study on the effect of home visits on the well-being of Danish colorectal cancer patients--the INCA Project.

Home visits by health care professionals may constitute a formalized social relationship in which cancer patients can be given emotional and informational support. We aimed at studying the effect of home visits on the well-being of colorectal cancer patients. A total of 249 Danish colorectal cancer patients undergoing abdominal surgery were randomly assigned to a control group or to an intervention group. The intervention group received 10 home visits carried out by a project nurse or a medical doctor during the first 2 years after discharge. Participants were interviewed 3, 6, 12, and 24 months after discharge in order to assess well-being. Using a linear mixed model, we found no overall effect of the intervention on well-being. We recommend that future psychosocial intervention studies include baseline screening for distress and recommend testing the effect of shorter but intensive interventions carried out by trained therapists.