Sustaining Physical Activity After Cancer Exercise Sessions

NCT06359210 | Recruiting DMC

• 2 other identifiers: 49734R33CA256656-03
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

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.

Conditions

Behavior Change Interventions; Exercise Oncology; Physical Activity Behavior

Keywords

exercise oncology; physical activity; behavior change; adaptive intervention; cancer survivors; physical activity maintenance; community partnerships

Outcome Measures

Primary Outcomes (1)

• Physical Activity program

  Examine the number of participants achieving the exercise guidelines for cancer survivors defined as moderate-intensity aerobic training at least three times per week, for at least 30 minutes, and resistance training at least two times per week. Aerobic exercise will be measured with an accelerometer (continuous bouts of ≥5 minutes of activity at ≥3 METs) and resistance exercise will be measured with a self-report questionnaire (duration and frequency). The measures will be aggregated to determine total amount of physical activity and whether this amount meets or exceeds the recommended guidelines.

  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 (3)

• Quality of Life (QOL)

  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

  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

  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 (1)

• Feasibility and acceptability of the PA maintenance intervention components

  Through study completion, an average of 9-months

Study Arms (4)

Group A- Complete Responder

NO INTERVENTION

Participant is randomized to the no further intervention group.

Group B- Complete Responder

EXPERIMENTAL

Participant is randomized to receive monthly physical activity behavior change discussion sessions for 3-months (total of three sessions).

Behavioral: Responder Monthly Behavior Change Discussion Sessions

Group C- Incomplete Responder

EXPERIMENTAL

Participant is randomized to receive monthly physical activity behavior change discussion sessions for 3-months (total of three sessions).

Behavioral: Incomplete Responder Monthly Behavior Change Discussion Sessions

Group D- Incomplete Responder

EXPERIMENTAL

Participant is randomized to receive monthly physical activity behavior change discussion sessions for 3-months (total of three sessions) AND bi-weekly exercise sessions (total of six sessions).

Behavioral: Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions

Interventions

Responder Monthly Behavior Change Discussion Sessions BEHAVIORAL

Monthly behavior change discussion sessions (3 total) for 12 weeks.

Group B- Complete Responder

Incomplete Responder Monthly Behavior Change Discussion Sessions BEHAVIORAL

Monthly behavior change discussion sessions (3 total) for 12 weeks.

Group C- Incomplete Responder

Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions BEHAVIORAL

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.

Group D- Incomplete Responder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colorado State University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Anschutz Medical Center

Aurora, Colorado, 80045, United States

RECRUITING

Colorado State University

Fort Collins, Colorado, 80526, United States

ACTIVE NOT RECRUITING

University of Wyoming

Laramie, Wyoming, 82072, United States

COMPLETED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Heather Leach, PhD

CONTACT

970-491-8951; heather.leach@colostate.edu

Elena Lancioni, MPH

CONTACT

970-425-6535; elena.lancioni@colostate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 11, 2024
• Study Start: March 4, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)