Breast Cancer, Colon Cancer
Conditions
Keywords
Physical activity, Exercise coaching
Brief 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.
Interventions
DEVICEResearch-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.
OTHERNational 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.
This device can automatically capture and classify different physical activities such as walking, running, biking, swimming and using an elliptical.
OTHERExercise 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
OTHERInterview
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
OTHERPhysical 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
OTHERPhysical 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.
OTHERHealth Surveys
Various health surveys will be completed to assess participant health and physical activities.
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eligible Participants - Participation Rate | 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 | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShirley Bluethmann
Wake Forest Baptist Comprehensive Cancer Center
Outcome results
None listed