Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
236 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-10-03
Study Completion Date
2029-05-31
Brief Summary
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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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Detailed Description
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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.
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.
Conditions
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Cancer
Exercise
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
two group, parallel randomized controlled trial
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
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).
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).
Study Groups
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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.
Group Type
EXPERIMENTAL
Behavioural Counselling
Intervention Type
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 + 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.
Group Type
ACTIVE_COMPARATOR
Exercise Counselling
Intervention Type
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
OTHER
Eligibility Criteria
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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)
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Toronto Rehabilitation Institute
OTHER
Sponsor Role
collaborator
University of British Columbia
OTHER
Sponsor Role
collaborator
University of Toronto
OTHER
Sponsor Role
lead
Responsible Party
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Linda Trinh
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Linda Trinh, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Exercise Oncology Lab - University of Toronto
Toronto, Ontario, Canada
Site Status
RECRUITING
Countries
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Canada
Central Contacts
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Facility Contacts
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Role: primary
References
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DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
518666
Identifier Type: -
Identifier Source: org_study_id
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