Clinical trial NCT03781154: Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors
Official title: Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: Physical activity
Survivors
Maintenance
Personal Training
Group Mediated Cognitive Behavior
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Colorado State University
First posted: 2018-12-19
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be prospectively assigned or allocated to either the group-based exercise intervention or control group for 12 weeks.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a two-arm trial, comparing the effects of a virtual 12-week group-based exercise intervention vs. control group on physical activity, physical fitness, and quality of life in colorectal cancer survivors, and explore multi-level determinants of physical activity maintenance, 6-months after intervention completion.

Detailed description: Participants will be prospectively assigned or allocated to either a the exercise intervention or a control group for 12-weeks. The control group will be provided with an informational handout from the American Cancer Society describing exercise recommendations and guidelines for cancer survivors. At the end of the study, control group participants will be offered compensation for participation in a community-based cancer specific exercise program (e.g., BfitBwell, Fit Cancer, Livestrong at the YMCA). Supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components. Sessions will be delivered synchronously (i.e., in real-time/live) via Zoom. Exercise will be individualized based on the results of baseline fitness assessments and medical history. The intervention will also include virtual, group-based discussion sessions which operationalize behavior change techniques to increase physical activity. Discussion sessions will take place in the same groups, synchronously, via Zoom.

Eligibility criteria: Inclusion Criteria:

1. Provision to sign and date the consent form
2. Fluent in English
3. Have access to a computer or phone with internet and a camera
4. Stated willingness to comply with all study procedures and be available for the duration of the study
5. Be a male or female aged 40 years or older at time of diagnosis
6. Histologically confirmed cancer of the colon or rectum (stages II-IV) if treated with curative intent, and no current evidence of metastatic disease
7. Completed resection or other surgery 3-24 months prior to enrollment
8. Received chemotherapy and/or radiation therapy within the previous year, with at least 1 cycle of intended chemotherapy completed (does not need to complete all cycles). No plans for additional chemotherapy or radiation therapy.

Exclusion Criteria:

1. Current evidence of metastatic disease
2. Existing participation in ≥150 minutes per week of at least moderate intensity PA
3. Known contraindications for exercise or not able to safely participate in exercise
4. Pregnant women (no testing required)

Primary outcomes:
measure: Physical Activity
timeFrame: From baseline to 12-weeks, and 6 months post intervention
Secondary outcomes:
measure: Physical Fitness: Aerobic
timeFrame: From baseline to 12-weeks and 6-months post intervention
measure: Physical Fitness: Strength and Endurance
timeFrame: From baseline to 12-weeks and 6 months post intervention
measure: Body Composition
timeFrame: From baseline to 12-weeks 6 months post intervention
measure: Body Composition
timeFrame: From baseline to 12 weeks
measure: Sleep Quality
timeFrame: From baseline to 12 weeks
measure: Quality of Life Assessment
timeFrame: From baseline to 12 weeks and 6 months post intervention
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Hospital
state: Colorado
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: Fort Collins
country: United States
facility: Harmony Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Wells Messersmith, MD
role: PRINCIPAL_INVESTIGATOR
References: