Behaviour Change for Cancer Survivors Trial
- Conditions
- CancerExercise
- Interventions
- Other: Behavioural CounsellingOther: Exercise Counselling
- Registration Number
- NCT06624930
- Lead Sponsor
- University of Toronto
- Brief Summary
This study will be a two-arm, multi-site RCT, to examine the effects of an entirely virtual, 6-month supervised PA program plus standard exercise counselling (PA+EC) versus a supervised PA plus motivationally-enhanced behavioral counselling (PA+BC) on moderate to vigorous physical activity (MVPA) in cancer survivors. A 6-month post intervention follow-up (T2) and 1-year post intervention follow-up (T3; 1-year follow-up from post-intervention) will take place after the intervention to address maintenance. The intervention is designed using evidence-based research in the fields of exercise oncology using effective clinical design and theoretical approaches, including behaviour change techniques, to gradually increase MVPA to at least 90 minutes per week in cancer survivors as per the exercise guidelines for cancer survivors.
- Detailed Description
Many cancer survivors suffer from long-term side effects well beyond treatment such as fatigue, depression, muscle loss, which contributes to poor quality of life (QoL). Physical activity (PA) has a positive impact on clinical outcomes including improvements in overall QoL, cancer-specific mortality, and reducing treatment-related toxicities. Despite these benefits, the majority of cancer survivors, like their non-cancer counterparts, are not meeting public health PA guidelines. With COVID-19 restrictions easing, the health impact of the new normal may be long-lasting as cancer survivors have higher morbidity and mortality after contracting COVID-19. However, cancer survivors are realizing that they can receive quality and engaging access to care virtually in real-time to self-manage their symptoms. This represents a unique opportunity to test and deliver distance-based interventions in both clinical supportive cancer care and research trials. Short-term supervised PA programs can improve fitness and participant-reported outcomes in cancer survivors, but PA declines significantly post-treatment and long-term adherence is often low. This may also be due to the lack of available programming and facility-based, supervised programs that are easy to access even when they do exist. To achieve long-term health benefits, behaviour change must be sustained. Behaviour change interventions are complex with numerous interacting components that are often poorly described, especially with regard to how maintenance is defined. This hinders the understanding of intervention components that might facilitate PA maintenance. Behaviour change interventions improve PA over the course of the intervention; however, PA declines are more pronounced as the length of time between follow-up assessments increase. Nevertheless, the inclusion of theoretical components increases the likelihood of behaviour change in these interventions.
Recent PA guidelines for cancer survivors suggest 90 minutes of moderate-to-vigorous PA (MVPA) per week, and at least 2 days of strength training per week to accrue clinical benefits. PA-related benefits are only realized if cancer survivors adhere to and maintain PA. However, 74.8% and 86.1% of cancer survivors are not currently meeting aerobic PA and combined PA guidelines, respectively. Given that cancer survivors face several barriers to engaging in in-person PA (e.g., distance from clinical/community programs, treatment-related side effects ), there is a need to develop and assess the efficacy of distance-based approaches. The quality and effectiveness of distance-based interventions relative to non-telehealth home-based exercise or rehabilitation interventions are still unclear. Theoretical approaches to identifying key motivational outcomes to facilitate the adoption and maintenance of PA are limited. Behaviour change techniques such as self-monitoring, goal setting, social support, and action planning are shown to be effective techniques. Interventions that have used behavioural theory in cancer populations produced the largest overall effect size for behaviour change. However, little is known about which intervention mediators (e.g., behaviour change techniques) are responsible for long-term PA adherence.
The dominant theoretical approach in PA and cancer survivorship studies are social cognitive theories. While informative, theories rarely focus on maintenance through enacting on intention-behaviour gap mechanisms. The Multi-process Action Control (M-PAC) framework has a causal structure where an individual moves from intention formation to adoption of action control and onto maintenance of action control. According to the M-PAC, reflective processes (i.e., instrumental attitudes \[expected benefits from performing PA\], affective judgements \[expected pleasure from performing PA\], perceived capability \[one's ability to perform PA\] and perceived opportunity \[perceived social/environmental circumstances to perform PA) are necessary for PA intention formation in cancer survivors. When these expectations are strong and positive, they culminate in the formation of PA intention (i.e., decision to enact regular PA). The dominant determinant when beginning regular PA is marked by the enactment of regulatory processes. Regulatory processes represent the behavioural, cognitive, and affective regulation strategies (e.g., planning, monitoring, attention focus) that are enacted to translate intention into PA. Finally, reflexive processes (i.e., habit \[learned cue-behavior associations\] and identity \[role self-categorization\] are those constructs that develop as a consequence of repeated successful behavioural outcomes over time. Therefore, while the M-PAC represents reflective, regulatory, and reflexive processes that build upon each other over time, each is expected to have some mediated feedback onto PA along with their own independent effect. Taken together, behaviour change is the product of reflective, regulatory, and reflexive processes that have facilitated an initial intention into successful on-going behaviour.
This proposal will address gaps in the PA maintenance literature to demonstrate: (1) changes in absolute values across behavioural performance of cancer survivors, (2) an increase in their magnitude of effect on PA over time; and (3) sex and gender differences in PA maintenance.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 236
- ≥18 years of age
- Confirmed diagnosis of cancer of any type (Stages I to III; localized)
- Have completed primary cancer treatment within 5 years
- At least 12 weeks after surgery completion
- At least 6 weeks after radiation treatment
- Proficient in English
- Physically inactive (self-report less than 90 min of MVPA/week )
- Ambulate in daily life with minimal gait aid use
- Access to a smartphone/tablet/computer with webcam for videoconferencing and a Bluetooth connection
- Access to the internet
- No cardiac contraindications (e.g., unstable angina, heart failure, coronary artery disease, diagnosed abnormality of heart rhythm)
- A medical condition that prohibits PA (e.g., joint restriction or weight bearing precautions)
- Uncontrolled comorbidities or cardiovascular contraindications that would increase risk associated with supervised and unsupervised exercise (e.g., cardiac contraindications, severe arthritis, recent fall within the last 6-12 months)
- Presence of advanced cancer (i.e., Stage IV; metastatic)
- Do not intend to live in Canada for the next 18 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical Activity + Behavioural Counselling (PA + BC) Behavioural Counselling The PA+BC group will be given an individualized, home-based aerobic and resistance prescription based on baseline assessment and previous work. The participants will also receive behavioural counselling support sessions with a QEP every two weeks during the intervention period (12 total). The focus of these sessions will incorporate tailored behaviour change content from the M-PAC framework. At the end of the 6-month program, an individualized PA prescription will be provided based on their fitness level (adjusted throughout) to continue achieving the PA goal for the 6-month post intervention and 1-year post intervention follow-up. Physical Activity + Exercise Couselling (PA + EC) Exercise Counselling The PA+EC group will be given an individualized, home-based aerobic and resistance prescription based on baseline assessment and previous work. The participants will also receive the same frequency of group-based and 1:1 counseling support sessions via Zoom as PA+BC participants. The focus of these sessions will be on exercise training principles for proper PA technique, how to monitor intensity, and progress PA safely to achieve the PA guidelines. The support sessions will be 30-45 minutes and delivered via Zoom each week in either group or 1:1 format depending on the topic.
- Primary Outcome Measures
Name Time Method Moderate-to-Vigorous Physical Activity T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention) Changes in MVPA will be assessed by accelerometry (ActiGraph Inc., Pensacola, FL.; model GT3X +). Participants will be mailed an accelerometer to wear on their right hip, fastened to a belt worn around the waist. The accelerometer will be worn during waking hours for 7 days, except when bathing or swimming.
- Secondary Outcome Measures
Name Time Method 6-Minute Walk Test T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention) 6-minute walk test for aerobic endurance; from the Senior Fitness Test . Further distance walked indicates better physical function.
30-s Chair Stand Test T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention) 30-s chair stand test for lower body strength; from the Senior Fitness Test . Higher scores indicates better physical function.
Self-reported Physical Activity T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention) Physical activity will be measured using a modified version of the (GLTEQ) Godin-Leisure Time Exercise Questionnaire 66 . This measure asks participants to self-report the frequency and duration of light, moderate, vigorous aerobic PA and resistance training for a typical week.
Functional Assessment of Cancer Therapy-General T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention) Quality of life will be assessed by the validated Functional Assessment of Cancer Therapy-General (FACT-G) which consists of physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB), and social well-being (SWB). 75
FACT-Fatigue T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention) Fatigue will be assessed by the validated FACT-Fatigue (FACT-F) scale which includes the 27 items from the FACT-G scale plus the 13-item fatigue subscale.
Reflective, Regulatory, and Reflexive Processes T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention) Standard measures from the M-PAC framework will be assessed including reflective processes of attitudes, and perceived capability and opportunity on a 7-point bipolar Likert scale.
Health Service Utilization Inventory T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention) Health Economics Evaluation-Costs will be tracked using the Health Service Utilization Inventory with the view of conducting a cost-effectiveness analysis. The incremental cost of the intervention will be estimated and compared to changes in utility values converted from EQ5D results to evaluate the incremental cost per quality-adjusted life year of PA+BC. This study will be conducted from the perspective of the Canadian public healthcare payer and the participant. This inventory will be partially completed by each participant as well as members of the research team. Participants will complete the Health-Service Utilization Inventory and the research team will complete the iMTA Productivity Cost Questionnaire.
iMTA Productivity Cost Questionaire T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention) Health Economics Evaluation-Costs will be tracked using the iMTA Productivity Cost Questionnaire with the view of conducting a cost-effectiveness analysis. The incremental cost of the intervention will be estimated and compared to changes in utility values converted from EQ5D results to evaluate the incremental cost per quality-adjusted life year of PA+BC. This study will be conducted from the perspective of the Canadian public healthcare payer and the participant. This inventory will be partially completed by each participant as well as members of the research team. Participants will complete the Health-Service Utilization Inventory and the research team will complete the iMTA Productivity Cost Questionnaire.
Age Baseline (T0) Demographic variable of age will be assessed. Units of measurement is years.
Sex Baseline (T0) Demographic variable of biological sex will be assessed. Response options are; male and female.
Gender Baseline (T0) Demographic variable of gender will be assessed. Response options include; male, female, and other (self-reported).
Marital status Baseline (T0) Demographic variable of marital status will be assessed. Response options are; single, married, common-law, separated, widowed, and divorced.
Highest Level of Education Baseline (T0) Demographic variable of highest level of education will be assessed. Response options are; some high school, completed high school, some university/college, completed university/college, some graduate school, completed graduate school.
Current Employment Status Baseline (T0) Demographic variable of current employment status will be assessed. Response options are; disability, retired, part-time, homemaker, full-time, and unemployed.
Ethnicity Baseline (T0) Demographic variable of ethnicity will be assessed. Response options are; White, Chinese, South Asian, Black, Filipino, Latin American, South East Asian, Arab, West Asian, Korean, Japanese, and other.
Body Mass Index Baseline (T0) Demographic variable of body mass index will be assessed. Units of measurement are height (ft.) and weight (lb.). Weight and height will be combined to report BMI in kg/m\^2.
Medical Demographics Baseline (T0) Medical variables include: cancer type, date of diagnosis, cancer stage, cancer spread, treatment, current status, recurrences, presence of side effects, impact of cancer on physical activity, comorbidities and current disease status.
Gender Index Baseline (T0) The Gender Index will be used to assess gender associated risk factors.
Trial Locations
- Locations (2)
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Exercise Oncology Lab - University of Toronto
🇨🇦Toronto, Ontario, Canada