Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors
NCT ID: NCT06340503
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-11-06
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Promoting Activity in Cancer Survivors
NCT03060941
Survivorship Care Plan in Promoting Physical Activity in Breast or Colorectal Cancer Survivors in Wisconsin
NCT02677389
Exercise in Improving Health and Quality of Life in Breast Cancer Survivors
NCT03679559
Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer Survivors
NCT04200482
Narrative Visualization for Breast Cancer Survivors' Physical Activity
NCT03612596
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercise Group
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.
Research-grade accelerometer
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.
National Comprehensive Cancer Network (NCCN) Education Materials
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.
Garmin Vivofit activity tracker
This device can automatically capture and classify different physical activities such as walking, running, biking, swimming and using an elliptical.
Exercise Consultation Calls
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
Interview
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
Physical Activity Index Assessment (Intervention Arm)
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
Health Surveys
Various health surveys will be completed to assess participant health and physical activities.
Delayed Exercise Group
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.
Research-grade accelerometer
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.
National Comprehensive Cancer Network (NCCN) Education Materials
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.
Garmin Vivofit activity tracker
This device can automatically capture and classify different physical activities such as walking, running, biking, swimming and using an elliptical.
Interview
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
Physical Activity Index Assessment (Control Arm)
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.
Health Surveys
Various health surveys will be completed to assess participant health and physical activities.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Research-grade accelerometer
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.
National Comprehensive Cancer Network (NCCN) Education Materials
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.
Garmin Vivofit activity tracker
This device can automatically capture and classify different physical activities such as walking, running, biking, swimming and using an elliptical.
Exercise Consultation Calls
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
Interview
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
Physical Activity Index Assessment (Intervention Arm)
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
Physical Activity Index Assessment (Control Arm)
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.
Health Surveys
Various health surveys will be completed to assess participant health and physical activities.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shirley Bluethmann
Role: PRINCIPAL_INVESTIGATOR
Wake Forest Baptist Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WFBCCC 01123
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00111331
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.