Clinical trial NCT04026659: The Feasibility of Implementing an Exercise Programme for Deconditioned Cancer Survivors
Official title: The Feasibility of Implementing an Exercise Programme for Deconditioned Cancer Survivors in a National Cancer Centre: FIXCAS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Exercise
Rehabilitation
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Irish Cancer Society
name: St. James's Hospital, Ireland
First posted: 2019-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Programme feasibility - recruitment rates as assessed by percentage of eligible study population that consent to participation
timeFrame: 24 weeks
measure: Programme feasibility - adherence as assessed by the number of prescribed supervised and unsupervised sessions completed by participants
timeFrame: 24 weeks
measure: Programme feasibility - retention rates as assessed by the number of participants completing the programme and number of dropouts
timeFrame: 24 weeks
measure: Programme feasibility - acceptability of the intervention as assessed by qualitative interviews
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in physical fitness
timeFrame: Baseline and 10 weeks
measure: Change in physical activity
timeFrame: Baseline and 10 weeks
measure: Change in physical performance
timeFrame: Baseline and 10 weeks
measure: Change in lower limb strength
timeFrame: Baseline and 10 weeks
measure: 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)
timeFrame: Baseline, 10 weeks, 24 weeks
measure: Change in Quality of Life (QoL) as assessed by the Euro-QoL-5 Dimension-5 Level (EQ-5D-5L).
timeFrame: Baseline, 10 weeks, 24 weeks
measure: Change in fatigue
timeFrame: Baseline and 10 weeks
measure: Change in incontinence (prostate cancer only)
timeFrame: Baseline and 10 weeks
measure: Change in sexual function (prostate cancer only)
timeFrame: Baseline and 10 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. James's Hospital
Study officials:
affiliation: University of Dublin, Trinity College
name: Grainne Sheill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Devenney K, Murphy N, Ryan R, Grant C, Kennedy J, Manecksha RP, Sheils O, McNeely ML, Hussey J, Sheill G. The feasibility of implementing an exercise programme for deconditioned cancer survivors in a national cancer centre: FIXCAS Study. HRB Open Res. 2020 Dec 18;2:24. doi: 10.12688/hrbopenres.12925.2. eCollection 2019.