Behaviour Change for Cancer Survivors Trial

ConditionsCancer Exercise

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Behavioural Counselling
Other intervention
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
Other intervention
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.

Treatment groups

236 Participants

are divided into 2 treatment groups

Group A: Physical Activity + Behavioural Counselling (PA + BC)Experimental treatment 1 intervention

Group B: Physical Activity + Exercise Couselling (PA + EC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame