Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors

Wake Forest University (WFU)

Status: Active, not recruiting

Conditions: Breast Cancer; Colon Cancer

Treatments: Device: Garmin Vivofit activity tracker; Other: Physical Activity Index Assessment (Control Arm); Other: Physical Activity Index Assessment (Intervention Arm); Other: National Comprehensive Cancer Network (NCCN) Education Materials; Other: Health Surveys; Other: Exercise Consultation Calls; Device: Research-grade accelerometer; Other: Interview

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06340503

P30CA012197 (U.S. NIH Grant/Contract)

IRB00111331

WFBCCC 01123 (Other Identifier)

Details and patient eligibility

About

The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer.

Full description

To assess the feasibility (participation rate, adherence, and retention) of the Physical Activity Index (PAI) intervention in breast and colon cancer survivors supported by exercise coaching and self-monitoring tools.

Enrollment: 20 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Survivors of breast or colon cancer (stages 0-III) diagnosed within the last three years prior to enrollment.
• Completed primary treatment (surgery, chemotherapy, and/or radiation) at least 3 months prior to enrollment.
• At least 50 years of age or older.
• Access to internet or cellular plan for video calls.
• Being willing and able to comply with the approved protocol and able to sign an IRB-approved informed consent document directly, remotely or via electronic consent.
• Able to read and speak English

Exclusion criteria

• Participants with metastatic disease.
• Participants with recurrence or diagnosis of a different cancer.
• Participants receiving treatment other than maintenance therapy for their primary cancer (breast or colon).
• Participants has prior conditions that contraindicate exercise as determined by treating physician.
• Participants has gross cognitive impairment as determined by treating physician.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Exercise Group

Experimental group

Description:

Participants randomized into the exercise group will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.

Treatment:

Other: Interview

Device: Research-grade accelerometer

Other: Exercise Consultation Calls

Other: Health Surveys

Other: National Comprehensive Cancer Network (NCCN) Education Materials

Other: Physical Activity Index Assessment (Intervention Arm)

Device: Garmin Vivofit activity tracker

Delayed Exercise Group

Active Comparator group

Description:

Participants randomized to the delayed exercise group, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.

Treatment:

Other: Interview

Device: Research-grade accelerometer

Other: Health Surveys

Other: National Comprehensive Cancer Network (NCCN) Education Materials

Other: Physical Activity Index Assessment (Control Arm)

Device: Garmin Vivofit activity tracker