scholarly journals Breast cancer application protocol: a randomised controlled trial to evaluate a self-management app for breast cancer survivors

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e034655
Author(s):  
Andy S K Cheng ◽  
Xiangyu Liu ◽  
Peter H F Ng ◽  
Cindy T T Kwok ◽  
Yingchun Zeng ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Breast Cancer Survivors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Readiness For Change ◽  
Self Management ◽  
Controlled Study ◽  
Control Group ◽  
Problem Solving Skills ◽  
Randomised Controlled

IntroductionThe eHealth technologies that are being designed for chronic disease constitute a global trend towards health assessment and self-management. However, most of these approaches tend to focus on a single symptom or problem rather than on the multiple problems that are characteristic of many of these chronic illnesses. The aim of this study is to examine the effectiveness of and adherence to a self-management application (app) that identifies multiple problem areas related to surviving breast cancer as the targeted chronic illness.Methods and analysisThis is a randomised controlled study. Eligible participants will be allocated randomly into either an intervention group or a control group at a 1:1 ratio. The intervention group will be assigned to the self-management app (‘Be-with-You’), while the control group will use a general health app (‘Sham’ app). The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills. The secondary outcomes will include group differences in self-efficacy, readiness for change and health-related quality of life. All of these outcomes will be measured at baseline and at 4 weeks and 12 weeks after intervention. In addition, usability of these two mobile apps will be measured at 4 weeks and 12 weeks after intervention. The planned sample size is 476.Ethics and disseminationThe Human Subjects Ethics Sub-committee of The Hong Kong Polytechnic University approved the study (HSEARS20190922001, 24 September 2019). Dissemination of findings will occur at the local, national and international levels.Trial registration numberChiCTR1900026244.

scholarly journals Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024589
Author(s):  
Wen Yao Mak ◽  
Loke Meng Ong ◽  
Bak Leong Goh ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Randomised Controlled ◽  
End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

scholarly journals Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e023017 ◽  
Author(s):  
Torunn Hatlen Nøst ◽  
Aslak Steinsbekk ◽  
Ola Bratås ◽  
Kjersti Grønning
Keyword(s):  
Chronic Pain ◽  
Healthcare Service ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Patient Activation ◽  
Self Management ◽  
Control Group ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectivesTo investigate the effects on persons with chronic pain after 3 months of a group-based chronic pain self-management course compared with a drop-in, low-impact outdoor physical group activity on patient activation and a range of secondary outcomes.DesignAn open, pragmatic, parallel group randomised controlled trial. Analyses were performed using a two-level linear mixed model.SettingAn easily accessible healthcare service provided by Norwegian public primary healthcare.ParticipantsA total of 121 participants with self-reported chronic pain for 3 months or more were randomised with 60 participants placed in the intervention group and 61 placed in the control group (mean age 53 years, 88% women, 63% pain for 10 years or more).InterventionsThe intervention group was offered a group-based chronic pain self-management course with 2.5-hour weekly sessions for a period of 6 weeks. The sessions consisted of education, movement exercises and emphasised group discussions. The control group was offered a low-impact outdoor group physical activity in 1-hour weekly sessions that consisted of walking and simple strength exercises for a period of 6 weeks.Main outcomesThe primary outcome was patient activation assessed using the Patient Activation Measure. Secondary outcomes measured included assessments of pain, anxiety and depression, pain self-efficacy, sense of coherence, health-related quality of life, well-being and the 30 s chair to stand test.ResultsThere was no effect after 3 months of the group-based chronic pain self-management course compared with the control group for the primary outcome, patient activation (estimated mean difference: −0.5, 95% CI –4.8 to 3.7, p=0.802).ConclusionsThere was no support for the self-management course having a better effect after 3 months than a low-impact outdoor physical activity offered the control group.Trial registration numberNCT02531282; Results.

scholarly journals Family Support-Based Intervention Using A Mobile Application By Pharmacists For Older Adults With Diabetes: A Randomised Controlled Trial

2021 ◽  
Author(s):  
Potjana Poonprapai ◽  
Sanguan Lerkiatbundit ◽  
Woranuch - Saengcharoen
Keyword(s):  
Family Support ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Elderly ◽  
Self Management ◽  
Control Group ◽  
Diabetes Knowledge ◽  
Randomised Controlled ◽  
Family Behaviour

Abstract Background Family support is crucial in the care of elderly patients with diabetes. Pharmacists have proven to play an important role in assisting patients to achieve goals of drug therapy. However, more information is needed to evaluate the potential benefits of family-based intervention through a mobile application by pharmacists in the elderly diabetes patients.Objective To evaluate the influences of family support-based intervention using a mobile application on glycaemic control and diabetes control-related outcomes in the older adults with diabetes. Setting A hospital in the south of Thailand.Method A randomised controlled trial was conducted with 9 months of follow-up. Family members in the intervention group (n = 78) received diabetes educational courses and encouragement via a mobile application from pharmacists to help their elderly relatives with diabetes in self-management tasks. The control group received usual care (n = 79). Main outcome measure Glycosylated haemoglobin (HbA1c).Results As compared to baseline, significant improvements were observed in the intervention patients for HbA1c, blood pressure, family behaviour in diabetes care, diabetes knowledge, self-management practices and medication adherence (P < 0.001). The intervention group showed greater decline in HbA1c levels relative to the control group (-0.97% vs. -0.12%; P = 0.001). Significant differences between groups for changes in blood pressure levels including scores of family behaviour, diabetes knowledge, self-management and medication adherence were found (P < 0.001), with the intervention group showing greater improvement. Conclusion Family support intervention via a mobile application by pharmacists is beneficial to diabetes care for the elderly. Trial registration number: TCTR20200615001 (date 13 June 2020, retrospectively registered).

scholarly journals Randomized Controlled Trial of Survivorship Care Plans Among Low-Income, Predominantly Latina Breast Cancer Survivors

2017 ◽  
Vol 35 (16) ◽  
pp. 1814-1821 ◽  
Author(s):  
Rose C. Maly ◽  
Li-Jung Liang ◽  
Yihang Liu ◽  
Jennifer J. Griggs ◽  
Patricia A. Ganz
Keyword(s):  
Breast Cancer ◽  
Low Income ◽  
Breast Cancer Survivors ◽  
Patient Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Survivorship Care Plans ◽  
Survivorship Care ◽  
Care Plans

Purpose The purpose of this study was to examine the effects of a randomized controlled trial (RCT) of treatment summaries and survivorship care plans coupled with a nurse counseling session, primarily on physician implementation of and secondarily on patient adherence to recommended survivorship care, among a low-income population of breast cancer survivors (survivors). Methods We recruited 212 low-income, predominantly Latina (72.6%) survivors with stage 0 to III breast cancer, with an average age of 53 years, from two Los Angeles County public hospitals into an RCT of a survivorship care nurse counseling session coupled with the provision of individualized treatment summaries and survivorship care plans to patients and their health care providers from December 2012 to July 2014. One hundred seven survivors received the experimental intervention, and 105 survivors received usual care. Multiple linear regression analyses were performed to assess intervention effects on physician implementation of and patient adherence to recommended survivorship care. Scales that served as covariables were Knowledge of Survivorship Issues, Perceived Efficacy in Patient-Physician Interactions, and Satisfaction With Care and Information. Results Survivors in the intervention group reported greater physician implementation of recommended breast cancer survivorship care, for example, treatment of depression or hot flashes, than did those in the control group (adjusted difference, 16 ± 5.3; P = .003). Baseline Satisfaction With Care and Information was positively associated with physician implementation (coefficient, 5.2 ± 2.2; P = .02). Being married/partnered (−11.8 ± 4.0; P = .004) and age (−0.5 ± 0.2; P = .028) were negatively associated with patient adherence. Conclusion To our knowledge, this is the first RCT of survivorship care plans to show benefits in clinical outcomes, in this case, showing increased physician implementation of recommended breast cancer survivorship care in the intervention group, compared with the control group.

scholarly journals Feasibility and acceptability of telehealth coaching to promote healthy eating in chronic kidney disease: a mixed-methods process evaluation

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024551 ◽  
Author(s):  
Jaimon T Kelly ◽  
Molly M Warner ◽  
Marguerite Conley ◽  
Dianne P Reidlinger ◽  
Tammy Hoffmann ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Kidney Disease ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Messages ◽  
Self Management ◽  
Control Group ◽  
Randomised Controlled

ObjectiveTo evaluate the feasibility and acceptability of a personalised telehealth intervention to support dietary self-management in adults with stage 3–4 chronic kidney disease (CKD).DesignMixed-methods process evaluation embedded in a randomised controlled trial.ParticipantsPeople with stage 3–4 CKD (estimated glomerular filtration rate [eGFR]15–60 mL/min/1.73 m2).SettingParticipants were recruited from three hospitals in Australia and completed the intervention in ambulatory community settings.InterventionThe intervention group received one telephone call per fortnight and 2–8 tailored text messages for 3 months, and then 4–12 tailored text messages for 3 months without telephone calls. The control group received usual care for 3 months then non-tailored education-only text messages for 3 months.Main outcome measuresFeasibility (recruitment, non-participation and retention rates, intervention fidelity and participant adherence) and acceptability (questionnaire and semistructured interviews).Statistical analyses performedDescriptive statistics and qualitative content analysis.ResultsOverall, 80/230 (35%) eligible patients who were approached consented to participate (mean±SD age 61.5±12.6 years). Retention was 93% and 98% in the intervention and control groups, respectively, and 96% of all planned intervention calls were completed. All participants in the intervention arm identified the tailored text messages as useful in supporting dietary self-management. In the control group, 27 (69%) reported the non-tailored text messages were useful in supporting change. Intervention group participants reported that the telehealth programme delivery methods were practical and able to be integrated into their lifestyle. Participants viewed the intervention as an acceptable, personalised alternative to face-face clinic consultations, and were satisfied with the frequency of contact.ConclusionsThis telehealth-delivered dietary coaching programme is an acceptable intervention which appears feasible for supporting dietary self-management in stage 3–4 CKD. A larger-scale randomised controlled trial is needed to evaluate the efficacy of the coaching programme on clinical and patient-reported outcomes.Trial registration numberACTRN12616001212448; Results.

scholarly journals Cardiorespiratory fitness in breast cancer survivors: a randomised controlled trial of home-based smartphone supported high intensity interval training

2021 ◽  
pp. bmjspcare-2021-003141
Author(s):  
Eisuke Ochi ◽  
Katsunori Tsuji ◽  
Tomomi Narisawa ◽  
Yoichi Shimizu ◽  
Aya Kuchiba ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Breast Cancer Survivors ◽  
Early Stage ◽  
Controlled Trial ◽  
Interval Training ◽  
Control Group ◽  
Home Based ◽  
High Intensity Interval ◽  
Randomised Controlled

BackgroundA strategy for maintaining and/or improving cardiorespiratory fitness (CRF) in the growing population of cancer survivors is of major clinical importance, especially in the COVID-19 era. The effect of unsupervised high-intensity interval training (HIIT) on increasing CRF in breast cancer survivors is unknown.PurposeThe purpose of this study was to determine whether the newly developed habit-B programme, which involves home-based smartphone-supported HIIT using body weight exercises, improves CRF in early-stage breast cancer survivors.MethodsThis single-centre, 12-week, parallel-group, single-blind, randomised controlled trial involved 50 women with stage I–IIa breast cancer, aged 20–59 years, who had completed initial treatment except for hormone therapy. Participants were randomised to either the exercise or control group. The primary outcome was the 12-week change in peak oxygen uptake (V˙O2peak). Other outcomes included muscle strength, 6 min walk test, resting heart rate, physical activity, fatigue, safety and quality of life.ResultsThe change in V˙O2peak and leg strength increased significantly in the exercise group compared with the control group (p<0.01). Changes in other outcomes were not significantly different between the groups.ConclusionA home-based HIIT intervention can lead to improve CRF and muscle strength in early-stage breast cancer survivors.

scholarly journals A pragmatic randomised controlled trial referring to a Personalised Self-management SUPport Programme (P-SUP) for persons enrolled in a disease management programme for type 2 diabetes mellitus and/or for coronary heart disease

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Uwe Konerding ◽  
Marcus Redaèlli ◽  
Karolin Ackermann ◽  
Sibel Altin ◽  
Sebastian Appelbaum ◽  
...  
Keyword(s):  
Disease Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Patient Activation ◽  
Self Management ◽  
Control Group ◽  
Randomised Controlled ◽  
Study Participants ◽  
Pragmatic Randomised Controlled Trial

Abstract Background Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases have been developed. In Germany, so-called disease management programmes (DMPs), which combine components of Disease Management and the Chronic Care Model, are applied. These DMPs have proven effective. Nevertheless, there are opportunities for improvement. Current DMPs rarely address self-management of the disease, make no use of peer support, and provide no special assistance for persons with low health literacy and/or low patient activation. The study protocol presented here is for the evaluation of a programme that addresses these possible shortcomings and can be combined with current German DMPs for T2DM and CHD. This programme consists of four components: Meetings of peer support groups Personalised telephone-based health coaching for patients with low literacy and/or low patient activation Personalised patient feedback A browser-based web portal Methods Study participants will be adults enrolled in a DMP for T2DM and/or CHD and living in North Rhine-Westphalia, a state of the Federal Republic of Germany. Study participants will be recruited with the assistance of their general practitioners by the end of June 2021. Evaluation will be performed as a pragmatic randomised controlled trial with one intervention group and one waiting control group. The intervention group will receive the intervention for 18 months. During this time, the waiting control group will continue with usual care and the usual measures of their DMPs. After 18 months, the waiting control group will also receive a shortened intervention. The primary outcome is number of hospital days. In addition, the effects on self-reported health-state, physical activity, nutrition, and eight different psychological variables will be investigated. Differences between values at month 18 and at the beginning will be compared to judge the effectiveness of the intervention. Discussion If the intervention proves effective, it may be included into the DMPs for T2DM and CHD. Trial registration The study was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) in early 2019 under the number 00020592. This registry has been affiliated with the WHO Clinical Trials Network (https://www.drks.de/drks_web/setLocale_EN.do) since 2008. It is based on the WHO template, but contains some additional categories for which information has to be given (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields ). A release and subsequent number assignment only take place when information for all categories has been given.

A patient-centered mobile intervention to promote self-management and improve patient outcomes in chronic heart failure: The ManageHF4Life trial (Preprint)

2020 ◽  
Author(s):  
Michael P. Dorsch ◽  
Karen B. Farris ◽  
Brigid E. Rowell ◽  
Scott L. Hummel ◽  
Todd M. Koelling
Keyword(s):  
Heart Failure ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Self Management ◽  
Control Group ◽  
Patient Centered ◽  
Self Monitoring ◽  
Heart Failure Questionnaire

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510

scholarly journals Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040108
Author(s):  
Rowan W Johnson ◽  
Sian A Williams ◽  
Daniel F Gucciardi ◽  
Natasha Bear ◽  
Noula Gibson
Keyword(s):  
Exercise Prescription ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Programme ◽  
Home Exercise ◽  
Control Group ◽  
Neurodevelopmental Disabilities ◽  
Home Exercise Programme ◽  
Exercise Programmes ◽  
Randomised Controlled

ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.

scholarly journals A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
M. A. Greidanus ◽  
A. E. de Rijk ◽  
A. G. E. M. de Boer ◽  
M. E. M. M. Bos ◽  
P. W. Plaisier ◽  
...  
Keyword(s):  
Return To Work ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Work Outcomes ◽  
Feasibility Trial ◽  
Control Group ◽  
Secondary Effect ◽  
Quality Of Working Life ◽  
Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

Sign in / Sign up

Export Citation Format

Share Document