Neoplasms Clinical Trial
Official title:
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.
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.
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