Clinical trial NCT06624930: Behaviour Change for Cancer Survivors Trial
Official title: A Randomized Controlled Trial Adding Behavioural Counselling to Supervised Physical Activity in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Exercise
Keywords: Cancer
Exercise
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Toronto Rehabilitation Institute
name: University of British Columbia
First posted: 2024-10-03
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two group, parallel randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study will be a two-arm, multi-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.

Eligibility criteria: 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)
* Do not intend to live in Canada for the next 18 months

Primary outcomes:
measure: Moderate-to-Vigorous Physical Activity
timeFrame: T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
Secondary outcomes:
measure: 6-Minute Walk Test
timeFrame: T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
measure: 30-s Chair Stand Test
timeFrame: T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
measure: Self-reported Physical Activity
timeFrame: T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
measure: Functional Assessment of Cancer Therapy-General
timeFrame: T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
measure: FACT-Fatigue
timeFrame: T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
measure: Reflective, Regulatory, and Reflexive Processes
timeFrame: T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
measure: Health Service Utilization Inventory
timeFrame: T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
measure: iMTA Productivity Cost Questionaire
timeFrame: T0 (Baseline), T1 (Mid-Point), T2 (Post-Intervention 6-Months), T3 (6-Month Follow Up After Intervention), T4 (1-Year Follow Up After Intervention)
measure: Age
timeFrame: Baseline (T0)
measure: Sex
timeFrame: Baseline (T0)
measure: Gender
timeFrame: Baseline (T0)
measure: Marital status
timeFrame: Baseline (T0)
measure: Highest Level of Education
timeFrame: Baseline (T0)
measure: Current Employment Status
timeFrame: Baseline (T0)
measure: Ethnicity
timeFrame: Baseline (T0)
measure: Body Mass Index
timeFrame: Baseline (T0)
measure: Medical Demographics
timeFrame: Baseline (T0)
measure: Gender Index
timeFrame: Baseline (T0)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: Exercise Oncology Lab - University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Linda Trinh, PhD
role: PRINCIPAL_INVESTIGATOR
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