Alberta Cancer Exercise Pilot Randomized Trial (ACE)
Alberta Cancer Exercise Community-based Program: A Pilot Randomized Controlled Trial
The purpose of the study is to examine the benefit and specific outcomes of a community-based exercise program that is designed to address the needs of individuals who are receiving or recovering from cancer treatment.
Eighty cancer survivors from Edmonton and Calgary will take part in the 24-week long study. Survivors will be randomly assigned to one of two groups. The first group will take part in an 8-week supervised exercise program followed by 8 weeks of self-directed or home-based exercise (early exercise group). The other 40 participants will continue with their normal activities for 16 weeks (delayed exercise group). After the 16 week period, participants in the delayed exercise group will take part in the 8-week supervised exercise program.
Exercise sessions will take place at selected YMCAs in Edmonton and Calgary. Exercise sessions will be supervised by specially trained exercise specialists who have received special training in exercise and cancer.
Outcomes of the study will include feasibility, physical fitness measures, cancer-related symptoms and quality of life.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Purpose: The primary purpose of this proposed study is to pilot test the planned Alberta Cancer Exercise (ACE) program evaluation components at the level of the individual cancer survivor. These components include program reach as well as effectiveness as determined by outcomes of physical fitness, symptoms, and quality of life. This proposed study will enable us to formalize an evaluation strategy to inform effectiveness and implementation of the ACE program.
Methods: A randomized controlled trial (RCT) design will be utilized to examine the short-term effectiveness of the proposed community-based cancer exercise program designed for cancer survivors. The study will take place at the Cross Cancer Institute/University of Alberta and Tom Baker Cancer Centre/ University of Calgary as well as in selected YMCA community fitness centres in Edmonton and Calgary. The exercise intervention will be delivered by specially trained exercise professionals who have completed the formal cancer exercise education course. Eighty participants will be randomized to early (intervention group) or delayed community-based exercise programming (standard care group). Participants randomized to the intervention group will undertake the ACE Program at a selected Edmonton and Calgary YMCA for an 8-week period. Following the 8-week supervised intervention period, participants will have the option to continue on a 'fee for service' basis or to continue with self-directed exercise at home. Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period. The standard care group will be offered participation in the 8-week ACE program at the completion of the 16-week follow-up period.
Outcomes: The primary outcome is program feasibility: recruitment, completion and adherence rates. For the purposes of the proposed study and the length of follow-up of 24 weeks, the RE-AIM components of Reach, Effectiveness and Implementation at the level of the individual will be evaluated as potential outcome indicators for the ACE program. Outcomes will include measures of health-related physical fitness, cancer-related symptoms and quality of life.
Summary: ACE is an active living initiative, encouraging cancer survivors in Alberta to take a role in their own wellbeing by supporting participation in cancer-specific community-based exercise programs.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Alberta
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Calgary, Alberta, Canada, T2N 1N4
- University of Calgary/ Tom Baker Cancer Centre
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Edmonton, Alberta, Canada, T6J4P9
- University of Alberta/ Cross Cancer Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Within 18 months of a diagnosis of any type of cancer
- Receiving or have received curative cancer treatment (e.g., surgery, chemotherapy, radiation therapy)
- Cleared for unrestricted physical activity by their treating oncologist
Exclusion Criteria:
- Presence of metastatic disease
- Any uncontrolled or serious comorbid conditions that would preclude participation in exercise testing and training
- Women who are pregnant
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Standard Care
Participants in this group will receive standard education on the importance of physical activity in the recovery from cancer and how to become more active.
Participants assigned to this group will have the option to participate in the exercise program after the 16-week follow-up assessment.
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Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period.
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Sperimentale: Supervised Community-based Exercise
Participants in this group will take part in an 8-week supervised exercise program at the YMCA.
Following the 8-week intervention, participants will have the option to continue for an additional 8-weeks at the YMCA (fee for service) or follow an 8-week self-directed program.
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Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period.
The participant exercise sessions will be conducted in small groups of 5 to 10 participants under the direct supervision of the community-based exercise specialist.
Participants will have the choice between taking part in a bridging exercise class (e.g., Beauty program and Bridging to Fitness - Cancer) or group-based supervised fitness centre exercise training.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Feasibility: number of participants completing the objective outcome measurements for the study
Lasso di tempo: 24 weeks
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Proportion of subjects completing the physical fitness tests including aerobic capacity, musculoskeletal fitness and body composition measurements.
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24 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Aerobic Capacity
Lasso di tempo: 8 weeks
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Change in submaximal aerobic exercise capacity (treadmill, bike or 6 minute walk test)
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8 weeks
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Health-related Quality of Life
Lasso di tempo: 8 weeks
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Change in quality of life: Functional Assessment of Cancer Therapy General Questionnaire
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8 weeks
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Symptom Assessment
Lasso di tempo: 8 weeks
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Change in symptoms: Memorial Symptom Assessment Scale
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8 weeks
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Adherence to exercise
Lasso di tempo: 24 weeks
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Attendance at supervised exercise sessions
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24 weeks
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Recruitment rate
Lasso di tempo: 18 months
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Number of participants consenting to the study divided by the number of eligible participants
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18 months
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Upper Extremity Muscular Strength (optional)
Lasso di tempo: 8 weeks
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Change in 8 repetition maximum strength of chest press
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8 weeks
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Upper Extremity Grip Strength (optional)
Lasso di tempo: 8 weeks
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Hand Grip strength
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8 weeks
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Lower Extremity Muscular Strength (optional)
Lasso di tempo: 8 weeks
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Change in 8 repetition maximum strength of leg press
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8 weeks
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Adverse Events rate
Lasso di tempo: 24 weeks
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Number of serious and minor adverse events
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24 weeks
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Program Costs
Lasso di tempo: 24 months
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Costs related to study personnel, fitness centre costs and participant related costs
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24 months
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Body composition
Lasso di tempo: 8 weeks
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Body mass index
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8 weeks
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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- HREBA-CC-14-0153
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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