Recruiting

Physical Activity

Sponsor:

Colorado State University

Code:

NCT06359210

Conditions

Exercise Oncology

Physical Activity Behavior

Behavior Change Interventions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Responder Monthly Behavior Change Discussion Sessions

Incomplete Responder Monthly Behavior Change Discussion Sessions

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

Study Details

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

Exercise Oncology

Physical Activity Behavior

Behavior Change Interventions

Study ID

NCT06359210

Start date

Mar 4, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Group A- Complete Responder

Participant is randomized to the no further intervention group.

experimental: Group B- Complete Responder

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

experimental: Group C- Incomplete Responder

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

experimental: Group D- Incomplete Responder

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).

Interventions

Responder Monthly Behavior Change Discussion Sessions

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

Incomplete Responder Monthly Behavior Change Discussion Sessions

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

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Heather Leach, PhD

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

Elena Lancioni, MPH

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

Locations

Anschutz Medical Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Ryan Marker, PhD, PT

(720) 848-0300ryan.marker@cuanschutz.edu

More Information

Sponsor

Colorado State University

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado State University on 2026-03-19.