Exercise Oncology Lab - University of Toronto
Toronto, Ontario, M5S 2W6, Canada
Location status: Recruiting
Location contact
CONTACT
NCT Number: NCT06624930
This study will be a two-arm 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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5S 2W6, Canada
Location status: Recruiting
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The PA+BC group will receive a behavioural counselling support session with a QEP every two weeks during the intervention period (12 total). Of the 12 video-conferencing calls, one session will target reflective processes (instrumental/affective attitudes), five sessions will target behavioural regulation (action planning, coping planning, social support, goal setting), and four sessions will target reflexive processing (self-regulation, habit). The remaining two sessions are "booster sessions" to revisit topics discussed. The importance of sustaining PA for clinical outcomes (e.g., fatigue) and PA logs will be stressed. 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.
The PA+EC group will receive the same frequency of group-based and 1:1 counseling support sessions via Zoom as PA+BC participants. However, the focus will be on exercise training principles for proper PA technique, how to monitor intensity, and progress PA safely to achieve the PA guidelines.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T0)
Demographic variable of age will be assessed. Units of measurement is years.
Time frame: Baseline (T0)
Demographic variable of biological sex will be assessed. Response options are; male and female.
Time frame: Baseline (T0)
Demographic variable of gender will be assessed. Response options include; male, female, and other (self-reported).
Time frame: Baseline (T0)
Demographic variable of marital status will be assessed. Response options are; single, married, common-law, separated, widowed, and divorced.
Time frame: 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.
Time frame: Baseline (T0)
Demographic variable of current employment status will be assessed. Response options are; disability, retired, part-time, homemaker, full-time, and unemployed.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T0)
The Gender Index will be used to assess gender associated risk factors.
Contact information is provided by the study sponsor or research team.
University of Toronto
Other
A Randomized Controlled Trial Adding Behavioural Counselling to Supervised Physical Activity in Cancer Survivors
Acronym: BOOST-Up
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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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