Recruiting

Behaviour Change

Sponsor:

University of Toronto

Code:

NCT06624930

Conditions

Cancer

Exercise

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioural Counselling

Exercise Counselling

Study Details

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

Study ID

NCT06624930

Start date

Oct 3, 2024

Status verified date

Sep, 2025

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

236 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Moderate-to-Vigorous Physical Activity [ 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) ]

Central Contacts and Locations

Central contacts

Linda Trinh, PhD

4169463624exercise.oncology@utoronto.ca

Emma V Tung, MSc

emma.tung@utoronto.ca

Locations

Exercise Oncology Lab - University of Toronto

Recruiting

Toronto, Ontario, Canada, M5S 2W6

Contacts

exercise.oncology@utoronto.ca

More Information

Sponsor

University of Toronto

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Keywords

  • Cancer
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2025-09-29.