Comparing Behavioural Counselling with Exercise Counselling for cancer
Official title: Behaviour Change for Cancer Survivors Trial
A Randomized Controlled Trial Adding Behavioural Counselling to Supervised Physical Activity in Cancer Survivors
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Other intervention
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.
- Other intervention
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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Exercise Oncology Lab - University of Toronto
Toronto, Ontario
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +≥18 years of age
- +Confirmed diagnosis of cancer of any type (Stages I to III; localized)
- +Have completed primary cancer treatment within 5 years
- +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)
- +At least 12 weeks after surgery completion
- +At least 6 weeks after radiation treatment
Exclusion
- −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)
- −A medical condition that prohibits PA (e.g., joint restriction or weight bearing precautions)
- −Presence of advanced cancer (i.e., Stage IV; metastatic)
- −Do not intend to live in Canada for the next 18 months
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Behavioural Counselling.
Registry label: A: Physical Activity + Behavioural Counselling (PA + BC)
Group B, the comparison group, receives Exercise Counselling.
Registry label: B: Physical Activity + Exercise Couselling (PA + EC)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 236 people.
The study is currently expected to finish around May 2029.
The main measurement is taken over: T0 (BaselineBaselineYour starting measurements, taken before treatment begins.Read more →), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow UpFollow-upContinued check-ins after the treatment part is finished.Read more → After Intervention), T4 (1-Year Follow Up After Intervention).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Moderate-to-Vigorous Physical Activity — measured over T0 (BaselineBaselineYour starting measurements, taken before treatment begins.Read more →), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow UpFollow-upContinued check-ins after the treatment part is finished.Read more → After Intervention), T4 (1-Year Follow Up After Intervention).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06624930 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Behavioural CounsellingOther
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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Exercise CounsellingOther
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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: T0 (BaselineBaselineYour starting measurements, taken before treatment begins.Read more →), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow UpFollow-upContinued check-ins after the treatment part is finished.Read more → After Intervention), T4 (1-Year Follow Up After Intervention).
The study as a whole is currently expected to finish around 2029-05-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 236 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.