Breast CancerNCT06340503
Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors
A study testing Research-grade accelerometer, National Comprehensive Cancer Network (NCCN) Education Materials and Garmin Vivofit activity tracker in people with Breast Cancer and Colon Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Breast Cancer, Colon Cancer
- What is being tested?
- Research-grade accelerometer, National Comprehensive Cancer Network (NCCN) Education Materials and Garmin Vivofit activity tracker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to 8 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors in Clinical Practice
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.
Read the 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.
- Conditions
- Breast Cancer, Colon Cancer
- Being tested
- Research-grade accelerometer, National Comprehensive Cancer Network (NCCN) Education Materials, Garmin Vivofit activity tracker, Exercise Consultation Calls, Interview
- Keywords
- Physical activity, Exercise coaching
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research-grade accelerometerDevice
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 MaterialsOther
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 trackerDevice
This device can automatically capture and classify different physical activities such as walking, running, biking, swimming and using an elliptical.
Exercise Consultation CallsOther
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
InterviewOther
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)Other
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)Other
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 SurveysOther
Various health surveys will be completed to assess participant health and physical activities.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | 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. Receives: Device: Research-grade accelerometer; Other: National Comprehensive Cancer Network (NCCN) Education Materials; Device: Garmin Vivofit activity tracker; Other: Exercise Consultation Calls; Other: Interview; Other: Physical Activity Index Assessment (Intervention Arm); Other: Health Surveys |
| Delayed Exercise Group | Active comparator | 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. Receives: Device: Research-grade accelerometer; Other: National Comprehensive Cancer Network (NCCN) Education Materials; Device: Garmin Vivofit activity tracker; Other: Interview; Other: Physical Activity Index Assessment (Control Arm); Other: Health Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eligible Participants - Participation Rate
Participation will be measured by the number of eligible participants who agree to participate. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
Measured: 17 months
Percentage of Participants to Complete Exercise Sessions - Adherence
Adherence will be measured by the percent of participants who complete at least 3 out 5 exercise sessions. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
Measured: 17 months
Number of Participants Who Complete Study Questionnaires - Retention
Retention will be defined as the number of participants who complete study questionnaires at baseline and one follow-up timepoint. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
Measured: At baseline and up to 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start6 Nov 2024
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shirley Bluethmann, Principal investigator, Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340503
- Sponsor's protocol ID
- IRB00111331
- Other IDs
- WFBCCC 01123, P30CA012197
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors in Clinical Practice
- ClinicalTrials.gov ID
- NCT06340503
- Acronym / sponsor ID
- IRB00111331
- Conditions
- Breast Cancer, Colon Cancer
- Keywords
- Physical activity, Exercise coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Device: Research-grade accelerometer, Other: National Comprehensive Cancer Network (NCCN) Education Materials, Device: Garmin Vivofit activity tracker, Other: Exercise Consultation Calls, Other: Interview, Other: Physical Activity Index Assessment (Intervention Arm), Other: Health SurveysParticipants 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. |
| Delayed Exercise Group | Active comparator | Device: Research-grade accelerometer, Other: National Comprehensive Cancer Network (NCCN) Education Materials, Device: Garmin Vivofit activity tracker, Other: Interview, Other: Physical Activity Index Assessment (Control Arm), Other: Health SurveysParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research-grade accelerometerParticipants 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. | Device | Delayed Exercise Group, Exercise Group |
| National Comprehensive Cancer Network (NCCN) Education MaterialsThe 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. | Other | Delayed Exercise Group, Exercise Group |
| Garmin Vivofit activity trackerThis device can automatically capture and classify different physical activities such as walking, running, biking, swimming and using an elliptical. | Device | Delayed Exercise Group, Exercise Group |
| Exercise Consultation CallsThe 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 | Other | Exercise Group |
| InterviewThe 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 | Other | Delayed Exercise Group, Exercise Group |
| 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 | Other | Exercise Group |
| 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. | Other | Delayed Exercise Group |
| Health SurveysVarious health surveys will be completed to assess participant health and physical activities. | Other | Delayed Exercise Group, Exercise Group |
Primary outcome
Number of Eligible Participants - Participation Rate
Time frame: 17 months
Participation will be measured by the number of eligible participants who agree to participate. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
Percentage of Participants to Complete Exercise Sessions - Adherence
Time frame: 17 months
Adherence will be measured by the percent of participants who complete at least 3 out 5 exercise sessions. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
Number of Participants Who Complete Study Questionnaires - Retention
Time frame: At baseline and up to 17 months
Retention will be defined as the number of participants who complete study questionnaires at baseline and one follow-up timepoint. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley Bluethmann principal investigator
Wake Forest Baptist Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research-grade accelerometer, National Comprehensive Cancer Network (NCCN) Education Materials and Garmin Vivofit activity tracker in people with Breast Cancer and Colon Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Eligible Participants - Participation Rate (time frame: 17 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.