Behaviour Change for Cancer Survivors Trial

NCT06624930 | Recruiting

• 1 other identifier: 518666
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Exercise

Keywords

Cancer; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Physical Activity + Behavioural Counselling (PA + BC)

EXPERIMENTAL

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

Physical Activity + Exercise Couselling (PA + EC)

ACTIVE COMPARATOR

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

Interventions

Behavioural Counselling OTHER

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.

Physical Activity + Behavioural Counselling (PA + BC)

Exercise Counselling OTHER

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.

Physical Activity + Exercise Couselling (PA + EC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Toronto Rehabilitation Institute: collaborator
• University of British Columbia: collaborator

Study Sites (1)

Exercise Oncology Lab - University of Toronto

Toronto, Ontario, M5S 2W6, Canada

RECRUITING

Related Publications (65)

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  PMID: 40346460 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Linda Trinh, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Trinh, PhD

CONTACT

4169463624; exercise.oncology@utoronto.ca

Emma V Tung, MSc

CONTACT

emma.tung@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All participants will be blinded to group assignment. Coordinating Research Assistants (RAs) will be the primary individuals responsible for scheduling all data collection assessments. The participants will attempt to book all 3 assessments with same RA assessor who meets the following criteria: * Are not a Qualified Exercise Professional (QEP) delivering one-on-one behavioural counselling * Are not a QEP that is running group webinar will not be involved in any data collection * Are not aware of participant's group allocation At the beginning of all data collection sessions, participants will be reminded not to disclose their any information about the activities performed for the study group assignment to the study assessor (RA).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: two group, parallel randomized controlled trial

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: October 3, 2024
• Study Start: October 3, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)