| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Other: Multi-modal exercise | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Feasibility of Implementing an Exercise Programme for Deconditioned Cancer Survivors in a National Cancer Centre: FIXCAS Study |
| Actual Study Start Date : | September 25, 2019 |
| Actual Primary Completion Date : | October 1, 2020 |
| Actual Study Completion Date : | October 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Multi-modal exercise programme
The 10-week multi-modal exercise programme will comprise of twice weekly supervised group-based exercise sessions. Each exercise session will last approximately 1 hour and consist of a combination of aerobic, resistance and balance and flexibility exercises.
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Other: Multi-modal exercise
A combination of aerobic, resistance, balance and flexibility exercises will be included. Aerobic exercise will consist of 20 to 30 min of moderate intensity exercise using a variety of modalities. Heart rate will be monitored using Polar hear rate monitors (target intensity 40-70% heart rate reserve) and the BORG Rating of Perceived Exertion (12-15). Resistance exercise will target the large muscle groups of the upper and lower extremities, be performed at 40% to 70% of the one repetition maximum (1-RM) and consist of two sets of 10-15 repetitions. Flexibility and balance exercise will also be included in the twice weekly programme. A home exercise programme will encourage participants to be moderately physically active for at least 30 minutes, three times per week in addition to the supervised programme.
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Quality of life is evaluated through the internationally established EORTC-QLQ-C30. The EORTC QLQ-C30 comprises 30 items (i.e. single questions), 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms.
All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Ireland | |
| St. James's Hospital | |
| Dublin, Ireland | |
| Principal Investigator: | Grainne Sheill, PhD | University of Dublin, Trinity College |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 2, 2019 | ||||
| First Posted Date ICMJE | July 19, 2019 | ||||
| Last Update Posted Date | November 30, 2020 | ||||
| Actual Study Start Date ICMJE | September 25, 2019 | ||||
| Actual Primary Completion Date | October 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Feasibility of Implementing an Exercise Programme for Deconditioned Cancer Survivors | ||||
| Official Title ICMJE | The Feasibility of Implementing an Exercise Programme for Deconditioned Cancer Survivors in a National Cancer Centre: FIXCAS Study | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Cancer | ||||
| Intervention ICMJE | Other: Multi-modal exercise
A combination of aerobic, resistance, balance and flexibility exercises will be included. Aerobic exercise will consist of 20 to 30 min of moderate intensity exercise using a variety of modalities. Heart rate will be monitored using Polar hear rate monitors (target intensity 40-70% heart rate reserve) and the BORG Rating of Perceived Exertion (12-15). Resistance exercise will target the large muscle groups of the upper and lower extremities, be performed at 40% to 70% of the one repetition maximum (1-RM) and consist of two sets of 10-15 repetitions. Flexibility and balance exercise will also be included in the twice weekly programme. A home exercise programme will encourage participants to be moderately physically active for at least 30 minutes, three times per week in addition to the supervised programme.
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| Study Arms ICMJE | Experimental: Multi-modal exercise programme
The 10-week multi-modal exercise programme will comprise of twice weekly supervised group-based exercise sessions. Each exercise session will last approximately 1 hour and consist of a combination of aerobic, resistance and balance and flexibility exercises.
Intervention: Other: Multi-modal exercise
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| Publications * | 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. Version 2. HRB Open Res. 2020 Dec 18 [revised 2020 Jan 1];2:24. doi: 10.12688/hrbopenres.12925.2. eCollection 2019. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
40 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | October 31, 2020 | ||||
| Actual Primary Completion Date | October 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Ireland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04026659 | ||||
| Other Study ID Numbers ICMJE | STS19SHE | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Grainne Sheill, University of Dublin, Trinity College | ||||
| Study Sponsor ICMJE | University of Dublin, Trinity College | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Dublin, Trinity College | ||||
| Verification Date | November 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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