Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624930
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Behaviour Change for Cancer Survivors Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial Adding Behavioural Counselling to Supervised Physical Activity in Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOOST-Up
Brief 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 PAEC versus a supervised PA plus motivationally-enhanced behavioral counselling PABC 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 748 and 861 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 eg distance from clinicalcommunity 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 eg 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 ie instrumental attitudes expected benefits from performing PA affective judgements expected pleasure from performing PA perceived capability ones ability to perform PA and perceived opportunity perceived socialenvironmental 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 ie 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 eg planning monitoring attention focus that are enacted to translate intention into PA Finally reflexive processes ie 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 748 and 861 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 eg distance from clinicalcommunity 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 eg 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 ie instrumental attitudes expected benefits from performing PA affective judgements expected pleasure from performing PA perceived capability ones ability to perform PA and perceived opportunity perceived socialenvironmental 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 ie 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 eg planning monitoring attention focus that are enacted to translate intention into PA Finally reflexive processes ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None