Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359210
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-20
Brief Title:
Sustaining Physical Activity After Cancer Exercise Sessions
Sponsor:
Colorado State University
Organization:
Colorado State University
Study Overview
Official Title:
An Adaptive Physical Activity Maintenance Intervention
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPAACES
Brief Summary:
The goal of this clinical trial is to develop and test an adaptive physical activity PA maintenance intervention for cancer survivors after participating in a community-based exercise oncology program The main questions it aims to answer are
Aim 1 Examine the feasibility and acceptability of the intervention among cancer survivors and community partners The researchers will utilize quantitative surveys focus groups and semi-structured interviews to collect information about feasibility implementation adaptation and sustainability
Aim 2 Examine the effects of the intervention among cancer survivors The researchers will compare the proportion of participants achieving the exercise guidelines for cancer survivors six-months following completion of the initial exercise program
Participants will participate in a community-based exercise oncology program and then return to three months of free living Based on the PA measured at the three-month follow-up participants will be categorized as a Responder or Incomplete Responder and then randomized to the PA maintenance intervention Researchers will compare those that are classified as Responders meeting exercise guidelines for cancer survivors and Incomplete Responders not meeting guidelines for cancer survivors to see what level of intervention is needed to influence sustainable behavior change in this population
Aim 1 Examine the feasibility and acceptability of the intervention among cancer survivors and community partners The researchers will utilize quantitative surveys focus groups and semi-structured interviews to collect information about feasibility implementation adaptation and sustainability
Aim 2 Examine the effects of the intervention among cancer survivors The researchers will compare the proportion of participants achieving the exercise guidelines for cancer survivors six-months following completion of the initial exercise program
Participants will participate in a community-based exercise oncology program and then return to three months of free living Based on the PA measured at the three-month follow-up participants will be categorized as a Responder or Incomplete Responder and then randomized to the PA maintenance intervention Researchers will compare those that are classified as Responders meeting exercise guidelines for cancer survivors and Incomplete Responders not meeting guidelines for cancer survivors to see what level of intervention is needed to influence sustainable behavior change in this population
Detailed Description:
Structured leisure-time physical activity PA ie aerobic and resistance exercise is effective for improving multiple health outcomes related to a cancer diagnosis and cancer treatment and may reduce cancer-specific mortality by as much as 40 Thus if cancer survivors can achieve and maintain recommended exercise levels the public health impact would be substantial
Supervised exercise interventions that include theory-based behavior change strategies are effective for facilitating increases in moderate to vigorous leisure-time PA among cancer survivors However few studies have focused on maintaining exercise or PA levels following completion of an intervention and evidence regarding how exercise interventions for cancer survivors can be expanded to clinic or community practice is only now emerging To achieve the physical psychosocial and survival benefits of exercise survivors must be able to maintain PA long-term and to support PA maintenance a socio-ecological approach is necessary Our approach is informed by theoretical frameworks including social cognitive theory and group dynamics which will guide intrapersonal and interpersonal level intervention strategies Integrated research-practice partnership models will guide strategies to address organizational and community-level influences
The goal is to develop and test an adaptive randomized trial to enhance PA maintenance among cancer survivors Our central hypothesis is that participants who have difficulty maintaining PA following a community-based exercise program will benefit from additional support in the form of bi-weekly exercise sessions andor PA behavior change discussion sessions Our long-term goal is to develop an evidence-based stepped PA maintenance intervention for cancer survivors that can be disseminated to existing community-based cancer-exercise programs nationwide In the proposed study cancer survivors will participate in an existing cancer-specific exercise program at a community-based facility
All programs will consist of group-based supervised instructor-led aerobic and resistance exercise sessions 2x per week and three PA behavior change discussion sessions Upon completion of the program participants will be encouraged to maintain PA levels during a three-month free-living period during which time there will be no active intervention After this follow-up period PA will be measured and based on PA response ie achieving exercise guidelines for cancer survivors participants will be randomized to a 3-month stepped PA maintenance intervention The primary outcome of PA maintenance will be assessed six-months after completion of the initial exercise program
Supervised exercise interventions that include theory-based behavior change strategies are effective for facilitating increases in moderate to vigorous leisure-time PA among cancer survivors However few studies have focused on maintaining exercise or PA levels following completion of an intervention and evidence regarding how exercise interventions for cancer survivors can be expanded to clinic or community practice is only now emerging To achieve the physical psychosocial and survival benefits of exercise survivors must be able to maintain PA long-term and to support PA maintenance a socio-ecological approach is necessary Our approach is informed by theoretical frameworks including social cognitive theory and group dynamics which will guide intrapersonal and interpersonal level intervention strategies Integrated research-practice partnership models will guide strategies to address organizational and community-level influences
The goal is to develop and test an adaptive randomized trial to enhance PA maintenance among cancer survivors Our central hypothesis is that participants who have difficulty maintaining PA following a community-based exercise program will benefit from additional support in the form of bi-weekly exercise sessions andor PA behavior change discussion sessions Our long-term goal is to develop an evidence-based stepped PA maintenance intervention for cancer survivors that can be disseminated to existing community-based cancer-exercise programs nationwide In the proposed study cancer survivors will participate in an existing cancer-specific exercise program at a community-based facility
All programs will consist of group-based supervised instructor-led aerobic and resistance exercise sessions 2x per week and three PA behavior change discussion sessions Upon completion of the program participants will be encouraged to maintain PA levels during a three-month free-living period during which time there will be no active intervention After this follow-up period PA will be measured and based on PA response ie achieving exercise guidelines for cancer survivors participants will be randomized to a 3-month stepped PA maintenance intervention The primary outcome of PA maintenance will be assessed six-months after completion of the initial exercise program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4R33CA256656-03 | NIH | None | httpsreporternihgovquickSearch4R33CA256656-03 |