To hear about similar clinical trials, please enter your email below
Trial Title:
Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors
NCT ID:
NCT06340503
Condition:
Breast Cancer
Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
Physical activity
Exercise coaching
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Research-grade accelerometer
Description:
Participants will be instructed to wear device for 7 days prior to each visit and to
bring the device to each visit. Study staff will extract data from the device within 14
days after each appointment and return the device to patients by mail.
Arm group label:
Patient Intervention Arm
Arm group label:
Waitlist Control Arm
Intervention type:
Other
Intervention name:
National Comprehensive Cancer Network (NCCN) Education Materials
Description:
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) are comprised of
recommendations for the prevention, diagnosis, and management of malignancies across the
continuum of care.
Arm group label:
Patient Intervention Arm
Arm group label:
Waitlist Control Arm
Intervention type:
Device
Intervention name:
Garmin Vivofit activity tracker
Description:
This device can automatically capture and classify different physical activities such as
walking, running, biking, swimming and using an elliptical.
Arm group label:
Patient Intervention Arm
Arm group label:
Waitlist Control Arm
Intervention type:
Other
Intervention name:
Exercise Consultation Calls
Description:
The intervention group will receive five monthly exercise consultation calls with an
exercise coach in between clinical visits and be provided with an exercise log for their
personal use
Arm group label:
Patient Intervention Arm
Intervention type:
Other
Intervention name:
Interview
Description:
The interviews will be conducted by a trained Q-PRO interviewer and audio recorded.
Interviews are expected to last approximately 30 minutes. Discussion will include
acceptability of the PAI intervention, related tools, and clinical experiences and will
help shape/inform refinements need for a larger efficacy trial
Arm group label:
Patient Intervention Arm
Arm group label:
Waitlist Control Arm
Intervention type:
Other
Intervention name:
Physical Activity Index Assessment (Intervention Arm)
Description:
Assessment will capture frequency and time spent in strenuous, moderate, and mild PA over
the past 7 days. Survivors also report hours of TV or similar sedentary screen time per
week as a measure of sedentary behavior. Completed at months 1, 3, 6, 9 and 12 while on
study
Arm group label:
Patient Intervention Arm
Intervention type:
Other
Intervention name:
Physical Activity Index Assessment (Control Arm)
Description:
Assessment will capture frequency and time spent in strenuous, moderate, and mild PA over
the past 7 days. Survivors also report hours of TV or similar sedentary screen time per
week as a measure of sedentary behavior. Completed at months 6, 9 and 12 while on study.
Arm group label:
Waitlist Control Arm
Intervention type:
Other
Intervention name:
Health Surveys
Description:
Various health surveys will be completed to assess participant health and physical
activities.
Arm group label:
Patient Intervention Arm
Arm group label:
Waitlist Control Arm
Summary:
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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 be to sign
an IRB-approved informed consent document directly.
- 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.
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Investigator:
Last name:
Shirley Bluethmann, PhD
Email:
Principal Investigator
Start date:
November 2024
Completion date:
September 2025
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06340503
