Behaviour Change for Cancer Survivors Trial (BOOST-Up)

A Randomized Controlled Trial Adding Behavioural Counselling to Supervised Physical Activity in Cancer Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Exercise
• Intervention / Treatment: Other: Behavioural Counselling; Other: Exercise Counselling

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.

• Study Type: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma V Tung, MSc; Email: emma.tung@utoronto.ca
• Study Contact Backup: Name: Linda Trinh, PhD; Phone Number: 4169463624; Email: exercise.oncology@utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 2W6
      • Recruiting
      • Exercise Oncology Lab - University of Toronto
      • Contact: Email: exercise.oncology@utoronto.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥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)

Exclusion Criteria:

• 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)
• Pregnancy
• Do not intend to live in Canada for the next 18 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Activity + Behavioural Counselling (PA + BC); 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.	Other: Behavioural Counselling; 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.
Active Comparator: Physical Activity + Exercise Couselling (PA + EC); 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.	Other: Exercise Counselling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate-to-Vigorous Physical Activity	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.	T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Minute Walk Test	6-minute walk test for aerobic endurance; from the Senior Fitness Test . Further distance walked indicates better physical function.	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	30-s chair stand test for lower body strength; from the Senior Fitness Test . Higher scores indicates better physical function.	T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
Self-reported Physical Activity	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.	T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
Functional Assessment of Cancer Therapy-General	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	T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
FACT-Fatigue	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.	T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
Reflective, Regulatory, and Reflexive Processes	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.	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 Service Utilization Inventory	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.	T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
iMTA Productivity Cost Questionaire	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.	T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
Age	Demographic variable of age will be assessed. Units of measurement is years.	Baseline (T0)
Sex	Demographic variable of biological sex will be assessed. Response options are; male and female.	Baseline (T0)
Gender	Demographic variable of gender will be assessed. Response options include; male, female, and other (self-reported).	Baseline (T0)
Marital status	Demographic variable of marital status will be assessed. Response options are; single, married, common-law, separated, widowed, and divorced.	Baseline (T0)
Highest Level of Education	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.	Baseline (T0)
Current Employment Status	Demographic variable of current employment status will be assessed. Response options are; disability, retired, part-time, homemaker, full-time, and unemployed.	Baseline (T0)
Ethnicity	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.	Baseline (T0)
Body Mass Index	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.	Baseline (T0)
Medical Demographics	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.	Baseline (T0)
Gender Index	The Gender Index will be used to assess gender associated risk factors.	Baseline (T0)

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: University of British Columbia; Toronto Rehabilitation Institute
• Investigators: Principal Investigator: Linda Trinh, PhD, University of Toronto

Publications and helpful links

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• Tabaczynski A, Arbour-Nicitopoulos KP, Rhodes RE, Sabiston CM, Trinh L. Correlates of Physical Activity Participation among Individuals Diagnosed with Cancer: An Application of the Multi-Process Action Control Framework. Int J Environ Res Public Health. 2023 Feb 28;20(5):4345. doi: 10.3390/ijerph20054345.
• Volz SC, Furman CR, Rothman AJ. Psychological Correlates of Perceived Physical Activity Engagement During the COVID-19 Pandemic Among Previously Active Individuals. Behav Med. 2023 Jan-Mar;49(1):7-14. doi: 10.1080/08964289.2021.1929811. Epub 2021 Oct 26.
• Rhodes RE, Liu S, Lithopoulos A, Zhang CQ, Garcia-Barrera MA. Correlates of Perceived Physical Activity Transitions during the COVID-19 Pandemic among Canadian Adults. Appl Psychol Health Well Being. 2020 Dec;12(4):1157-1182. doi: 10.1111/aphw.12236. Epub 2020 Oct 1.
• Elshahat S, Treanor C, Donnelly M. Factors influencing physical activity participation among people living with or beyond cancer: a systematic scoping review. Int J Behav Nutr Phys Act. 2021 Apr 6;18(1):50. doi: 10.1186/s12966-021-01116-9.
• Wright CE, Rhodes RE, Ruggiero EW, Sheeran P. Benchmarking the effectiveness of interventions to promote physical activity: A metasynthesis. Health Psychol. 2021 Nov;40(11):811-821. doi: 10.1037/hea0001118.
• Vallerand JR, Rhodes RE, Walker GJ, Courneya KS. Correlates of meeting the combined and independent aerobic and strength exercise guidelines in hematologic cancer survivors. Int J Behav Nutr Phys Act. 2017 Mar 28;14(1):44. doi: 10.1186/s12966-017-0498-7.
• Trinh L, Plotnikoff RC, Rhodes RE, North S, Courneya KS. Correlates of physical activity in a population-based sample of kidney cancer survivors: an application of the theory of planned behavior. Int J Behav Nutr Phys Act. 2012 Aug 6;9:96. doi: 10.1186/1479-5868-9-96.
• Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J. The Functional Assessment of Cancer Therapy Scale: Development and Validation of the General Measure. J Clin Oncol. 2023 Dec 10;41(35):5335-5344. doi: 10.1200/JCO.22.02775.
• Day S, Mason R, Tannenbaum C, Rochon PA. Essential metrics for assessing sex & gender integration in health research proposals involving human participants. PLoS One. 2017 Aug 30;12(8):e0182812. doi: 10.1371/journal.pone.0182812. eCollection 2017.
• Pelletier R, Ditto B, Pilote L. A composite measure of gender and its association with risk factors in patients with premature acute coronary syndrome. Psychosom Med. 2015 Jun;77(5):517-26. doi: 10.1097/PSY.0000000000000186.
• Pilote L, Karp I. GENESIS-PRAXY (GENdEr and Sex determInantS of cardiovascular disease: From bench to beyond-Premature Acute Coronary SYndrome). Am Heart J. 2012 May;163(5):741-746.e2. doi: 10.1016/j.ahj.2012.01.022.
• Norris CM, Johnson NL, Hardwicke-Brown E, McEwan M, Pelletier R, Pilote L. The Contribution of Gender to Apparent Sex Differences in Health Status Among Patients with Coronary Artery Disease. J Womens Health (Larchmt). 2017 Jan;26(1):50-57. doi: 10.1089/jwh.2016.5744. Epub 2016 Jul 11.
• Rhodes RE, Beauchamp MR, Quinlan A, Symons Downs D, Warburton DER, Blanchard CM. Predicting the physical activity of new parents who participated in a physical activity intervention. Soc Sci Med. 2021 Sep;284:114221. doi: 10.1016/j.socscimed.2021.114221. Epub 2021 Jul 10.
• Brucker PS, Yost K, Cashy J, Webster K, Cella D. General population and cancer patient norms for the Functional Assessment of Cancer Therapy-General (FACT-G). Eval Health Prof. 2005 Jun;28(2):192-211. doi: 10.1177/0163278705275341.
• Trinh L, Rhodes RE, Alibhai SMH, Campbell KL, Langelier DM, Chang E, Colella T, Chan B, Santa Mina D, Oh P, McAuley E. A randomized controlled trial adding behavioral counseling to supervised physical activity in people living with and beyond cancer (BOOST-UP-): a study protocol for a live remotely-delivered behavior change intervention. BMC Cancer. 2025 May 9;25(1):847. doi: 10.1186/s12885-025-13904-8.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Cancer
• Additional Relevant MeSH Terms: Behavior; Neoplasms; Motor Activity; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: 518666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No