Sustaining Physical Activity After Cancer Exercise Sessions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColorado State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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),
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Responder Monthly Behavior Change Discussion Sessions
BehavioralMonthly behavior change discussion sessions (3 total) for 12 weeks.
Incomplete Responder Monthly Behavior Change Discussion Sessions
BehavioralMonthly behavior change discussion sessions (3 total) for 12 weeks.
Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions
BehavioralMonthly 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.
Treatment groups
105 Participants
are divided into 4 treatment groupsGroup A: Group A- Complete ResponderNo intervention 0 interventions
Group B: Group B- Complete ResponderExperimental treatment 1 intervention
Group C: Group C- Incomplete ResponderExperimental treatment 1 intervention
Group D: Group D- Incomplete ResponderExperimental treatment 1 intervention
Trial outcomes
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.
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 programSecondary outcomes
1
Quality of Life (QOL)
Measured using the Functional Assessment of Cancer Therapy-General (FACT-G), a quantitative, self-report measure of QOL. The FACT-G is a 27-item self-report measure, with subscales evaluating physical, social, emotional, and functional well-being. FACT-G scores range from 0 to 108, with higher total and subscale scores indicating better 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 program2
Physical Fitness - Aerobic
Aerobic fitness will be assessed with either a submaximal, graded exercise test on a motorized, calibrated treadmill, or the two minute step test.
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 program3
Physical Fitness - muscular strength and endurance
Muscular strength and endurance will be assessed by the number of full stands from a chair, and the number of bicep curls (holding a hand weight of 5lbs) that can be completed in 30 seconds.
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 programOther outcomes
1
Feasibility and acceptability of the PA maintenance intervention components
Feasibility will include rate of recruitment, participant retention, completeness of data, and number of adverse events. Acceptability, among participants (i.e., cancer survivors) will be assessed via survey, and focus groups. Acceptability, implementation, and integration of the intervention among community facility leaders and fitness professionals will be assessed via semi-structured, face-to-face interviews which will focus on their satisfaction with the intervention delivery (i.e., cost, time, etc.), responses they observed from study participants, and sustainability within the organizational structure. Collectively, these outcomes will be aggregated to determine whether the maintenance intervention would be feasible to sustain in the community-based program.
Time frame
Through study completion, an average of 9-monthsSponsors and contacts
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Colorado State University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov