University of Alberta
Edmonton, Alberta, t6g 2h9, Canada
NCT Number: NCT03052777
This study evaluates the impact of a 12-week theory-based exercise telephone counselling program (versus a self-directed exercise group) on closing the exercise intention-behavior gap in a sample of hematologic cancer survivors.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Edmonton, Alberta, t6g 2h9, Canada
Problem: Regular exercise participation improves quality of life and physical function for cancer survivors. Unfortunately, the most effective way of promoting exercise to cancer survivors has yet to be determined, and as a result, many survivors are inactive. Theory-based efforts have typically focused on promoting intentions to exercise, though we are now discovering that only about half of those who intend to exercise actually follow through on their intentions. This is known as the exercise intention-behavior gap. It also appears that survivors are more likely to follow-through on their intention to exercise when they report employing key behavioral and motivational strategies (i.e., creating detailed exercise plans, feeling capable and obligated to exercise, perceiving it to be beneficial and fun, and avoiding the temptation to participate in alternative activities) which may be promoted via telephone counselling.
Objective: To determine whether a theory-based telephone counselling intervention focused on closing the exercise intention-behavior gap is feasible and can improve exercise levels, motivation, quality of life, and fatigue in hematologic cancer survivors.
Methods: A two-armed randomized controlled trial will compare the efficacy of telephone counselling versus a control condition (self-directed with Canada's Physical Activity Guide). All participants will be asked to increase their exercise by at least 60 minutes per week. Hematologic cancer survivors who previously participated in an exercise survey study and indicated interest in participating in future exercise related research (N=407) will be contacted to participate in the current trial. Eligible participants will be randomized in a 1:1 ratio to either the telephone counseling group or a self-directed exercise group. Participants in the intervention arm will receive 12 weekly telephone counseling sessions aimed at helping survivors follow-through on their exercise intention. A sample of approximately N=66 hematologic cancer survivors will be recruited for this 12-week trial. Data will be collected via online surveys assessing changes in exercise levels, motivation, quality of life, and fatigue. Feasibility will be determined by eligibility percentage, recruitment percentage, adherence rate, assessment completion rate, adverse events, and ratings of program acceptability.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention is a 12 week telephone counselling exercise program where participants will receive weekly telephone counselling that targets key theoretical behavior change constructs. Participants will also receive a copy of Canada's Physical Activity Guideline.
Time frame: Baseline and within 7 days of completing the 12-week intervention
Exercise levels assessed using the Godin Leisure-Time Exercise Questionnaire
Time frame: Baseline and within 7 days of completing the 12-week intervention
Exercise motivation assessed via validated questionnaires that align with the Multi-Process Action Control Framework
Time frame: Baseline and within 7 days of completing the 12-week intervention
Quality of life assessed using the Short Form-36 (SF-36) questionnaire
Time frame: Baseline and within 7 days of completing the 12-week intervention
Fatigue assessed using the Functional Assessment of Cancer Therapy: Fatigue (FACT-F) questionnaire
University of Alberta
Other
Improving Quality of Life in Hematologic Cancer Survivors by Closing the Exercise Intention-Behavior Gap: a Phase II Randomized Controlled Trial of a Theory-based, Telephone-delivered Exercise Counselling Intervention
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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