Trial Title:
Behaviour Change for Cancer Survivors Trial
NCT ID:
NCT06624930
Condition:
Cancer
Exercise
Conditions: Keywords:
Cancer
Exercise
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
two group, parallel randomized controlled trial
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
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).
Intervention:
Intervention type:
Other
Intervention name:
Behavioural Counselling
Description:
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.
Arm group label:
Physical Activity + Behavioural Counselling (PA + BC)
Intervention type:
Other
Intervention name:
Exercise Counselling
Description:
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.
Arm group label:
Physical Activity + Exercise Couselling (PA + EC)
Summary:
This study will be a two-arm, single-site 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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥18 years of age
- Confirmed diagnosis of cancer of any type (Stages I to III; localized)
- 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,
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)
- Do not intend to live in Canada for the next 18 months
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Exercise Oncology Lab - University of Toronto
Address:
City:
Toronto
Zip:
M5S 2W6
Country:
Canada
Status:
Recruiting
Start date:
October 3, 2024
Completion date:
May 31, 2029
Lead sponsor:
Agency:
University of Toronto
Agency class:
Other
Collaborator:
Agency:
Toronto Rehabilitation Institute
Agency class:
Other
Collaborator:
Agency:
University of British Columbia
Agency class:
Other
Source:
University of Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06624930
