Clinical trial NCT06359210: Sustaining Physical Activity After Cancer Exercise Sessions
Official title: An Adaptive Physical Activity Maintenance Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Oncology
Physical Activity Behavior
Behavior Change Interventions
Keywords: exercise oncology
physical activity
behavior change
adaptive intervention
cancer survivors
physical activity maintenance
community partnerships
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-04-11
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: An adaptive design results in a final total of 4 possible subgroups, depending upon responder/non-responder status, and researchers plan to compare the proportion of participants achieving the minimum exercise guidelines for cancer survivors within the responders and incomplete responder subgroups. Admittedly however, it is not possible to fully elucidate the analyses the researchers will conduct, as researchers cannot predict the number of subgroups that participants will represent at the end of the trial (e.g., if there are no "incomplete responders" the design reduces to randomization to only two groups), nor the number of participants who will be in those subgroups
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Structured leisure-time physical activity (PA) (i.e., 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 and/or 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 (i.e., 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.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old,
* Able to speak/read English,
* Diagnosed with any type of cancer,
* Completed primary or adjuvant treatment (i.e., chemotherapy, radiation therapy, surgery) within the previous five years, with no planned treatment within the next nine months. This does not include long-term or chronic therapies such as anti-hormone or targeted therapies (e.g., aromatase inhibitor, androgen deprivation therapy),
* Participant is registered/enrolled to participate in one of three community-based exercise programs.

Exclusion Criteria:

* Existing participation in ≥90 minutes per week of at least moderate intensity aerobic exercise AND two or more days per week of resistance exercise or known contraindications for exercise.
* Known contraindications for non-medically supervised moderate or greater intensity exercise (e.g., uncontrolled hypertension, inability to walk without an assistive device)
* Current or planned participation in another exercise oncology program (not one of the three community partner exercise programs), or previous participation in another or one of the three community partner exercise programs in the past 12-months.

Primary outcomes:
measure: Physical Activity program
timeFrame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
Secondary outcomes:
measure: Quality of Life (QOL)
timeFrame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
measure: Physical Fitness - Aerobic
timeFrame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
measure: Physical Fitness - muscular strength and endurance
timeFrame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
Other outcomes:
measure: Feasibility and acceptability of the PA maintenance intervention components
timeFrame: Through study completion, an average of 9-months
Locations:
city: Aurora
country: United States
facility: Anschutz Medical Center
state: Colorado
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: Laramie
country: United States
facility: University of Wyoming
state: Wyoming
Study officials:
References: