Sustaining Physical Activity After Cancer Exercise Sessions

Official title

An Adaptive Physical Activity Maintenance Intervention

Overview

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.

Interventions

• Behavioral Responder Monthly Behavior Change Discussion Sessions
  Monthly behavior change discussion sessions (3 total) for 12 weeks.
• Behavioral Incomplete Responder Monthly Behavior Change Discussion Sessions
  Monthly behavior change discussion sessions (3 total) for 12 weeks.
• Behavioral Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions
  Monthly behavior change discussion sessions (3 total) for 12 weeks and attend bi-weekly (every other week) exercise classes that mirror the exercises completed in their respective community-based exercise program.

Primary outcome measures

• Physical Activity program [Time frame: 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 outcome measures (3)

• Quality of Life (QOL) [Time frame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program]
• Physical Fitness - Aerobic [Time frame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program]
• Physical Fitness - muscular strength and endurance [Time frame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 3 centers

• Anschutz Medical Center — Aurora
• Colorado State University — Fort Collins
• University of Wyoming — Laramie

Identifiers

NCT: NCT06359210 · 4973 · 4R33CA256656-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗