The Feasibility of Implementing an Exercise Programme for Deconditioned Cancer Survivors in a National Cancer Centre: FIXCAS Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of Dublin, Trinity College
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Programme feasibility - adherence as assessed by the number of prescribed supervised and unsupervised sessions completed by participants
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
As both the number of cancer survivors and the length of survival time are increasing, long-term health issues related to cancer and its treatment are becoming more prevalent. Research suggests that exercise can mitigate a number of negative health consequences in cancer survivors and improve physical function and quality of life. Multi-modal exercise interventions have been proposed as a cornerstone for survivorship care. However, studies evaluating exercise programmes within the Irish population are lacking. The aim of the study is to evaluate the introduction, implementation and acceptability of a multi-modal exercise rehabilitation programme for deconditioned cancer survivors in a real-world, standard practice setting.
Detailed Description
There are currently more than 150,000 cancer survivors in Ireland, and this number continues to rise. Subsequently, as both the number of cancer survivors and the length of survival time are increasing, long-term health issues related to cancer and its treatment are becoming more prevalent. Depending on the specific treatment exposures, cancer survivors can face numerous adverse consequences of cancer treatment. Numerous systematic reviews demonstrate that exercise can mitigate a number of these factors in cancer survivors and improve quality of life, cardiorespiratory fitness, physical functioning, fatigue and can optimise functional status, preserving the ability to remain in the workforce and fulfil other life roles. Despite the robust body of existing literature, addressing the long term side effects of cancer is a major challenge for health care policy and the integration and delivery of exercise rehabilitation and survivorship into standard clinical cancer care in Ireland continues to remain the exception rather than the norm. Internationally, models of cancer survivorship care have been developing rapidly in recent years, many centring on the provision of exercise rehabilitation programmes across diverse delivery settings. However, referral to exercise specialists is not a part of the standard care received by oncology patients in Ireland with a distinct lack of rehabilitation services available for cancer survivors. The aim of the FIXCAS study is to examine the feasibility of implementing a 10 week multi-modal exercise rehabilitation programme to deconditioned cancer survivors in a National Cancer Centre. This single-arm prospective feasibility study will evaluate the introduction, implementation and acceptability of an exercise rehabilitation programme for deconditioned cancer survivors in a real-world, standard practice setting. A convenience sample of cancer survivors (n=40) aged 18 or older that have completed treatment with curative intent attending outpatient oncology services in a National Cancer Centre will be recruited. Participants will undergo a 10-week multi-modal exercise programme. Feasibility will be evaluated in terms of recruitment, adherence and compliance to the programme. Secondary outcomes will examine physical function and quality of life measures. In addition, the acceptability of the programme will be assessed through patient feedback. The study results will be used to optimise the intervention content, and may serve as the foundation for a larger definitive trial.
Investigators
Grainne Sheill
Principal Investigator
University of Dublin, Trinity College
Eligibility Criteria
Inclusion Criteria
- •18+ years old
- •Diagnosis of solid tumour
- •Completion of chemotherapy and/or radiotherapy with curative intent within the preceding 2-6 months
- •Medically fit to participate in moderate physical activity
Exclusion Criteria
- •Moderate or severe cognitive impairment
- •Current pregnancy
- •Individuals receiving treatment in the palliative setting
Outcomes
Primary Outcomes
Programme feasibility - adherence as assessed by the number of prescribed supervised and unsupervised sessions completed by participants
Time Frame: 24 weeks
The primary outcome of this study will be its feasibility aspects including programme adherence (number of prescribed supervised and unsupervised sessions completed by participants)
Programme feasibility - recruitment rates as assessed by percentage of eligible study population that consent to participation
Time Frame: 24 weeks
The primary outcome of this study will be its feasibility aspects including recruitment rates (percentage of eligible study population that consent to participation)
Programme feasibility - retention rates as assessed by the number of participants completing the programme and number of dropouts
Time Frame: 24 weeks
The primary outcome of this study will be its feasibility aspects including programme retention rates (number of participants completing the programme and number of dropouts)
Programme feasibility - acceptability of the intervention as assessed by qualitative interviews
Time Frame: 24 weeks
Acceptability of the intervention will be explored through qualitative interviews. Key stakeholders, namely participants in the exercise intervention and health professionals referring to the exercise programme will be invited to participate in semi-structured interviews. Health professionals (n=8-10) referring to the programme will be interviewed to examine their experience of referring to the FIXCAS programme to identify barriers and facilitators to referral and to determine areas for review and further development. Patients (n=10-15) will be asked to evaluate satisfaction with the intervention. Open-ended questions will be used to encourage reflection and elaboration on different aspects of the programme. The interviews will be recorded and transcribed, and data analysis of the interviews will occur through content analysis using simple descriptive thematic analyses.
Secondary Outcomes
- Change in Quality of Life (QoL) as assessed by the European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)(Baseline, 10 weeks, 24 weeks)
- Change in physical fitness(Baseline and 10 weeks)
- Change in physical activity(Baseline and 10 weeks)
- Change in physical performance(Baseline and 10 weeks)
- Change in lower limb strength(Baseline and 10 weeks)
- Change in incontinence (prostate cancer only)(Baseline and 10 weeks)
- Change in Quality of Life (QoL) as assessed by the Euro-QoL-5 Dimension-5 Level (EQ-5D-5L).(Baseline, 10 weeks, 24 weeks)
- Change in fatigue(Baseline and 10 weeks)
- Change in sexual function (prostate cancer only)(Baseline and 10 weeks)