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De klinische studie NCT06340503 voor Borstkanker, Dikkedarmkanker is actief, niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Wake Forest UniversityEvaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors
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De klinische studie NCT06340503 is een interventioneel studie bij Borstkanker, Dikkedarmkanker met de status actief, niet rekruterend. Het doel is om 20 deelnemers te includeren vanaf 6 november 2024. De studie wordt geleid door Wake Forest University en de voltooiing is gepland op 1 juni 2026. Laatste update op ClinicalTrials.gov: 2 juli 2025.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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.
Officiële titel
Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors in Clinical Practice
Aandoeningen
BorstkankerDikkedarmkankerAndere studie-ID's
- IRB00111331
- WFBCCC 01123 (Overige identificatiecode) (Atrium Health Wake Forest Baptist Comprehensive Cancer Center)
- P30CA012197 (Subsidie/contract van NIH (VS))
NCT-ID
Startdatum (Werkelijk)
2024-11-06
Laatste update geplaatst
2025-07-02
Verwachte einddatum
2026-06
Inschrijving (Geschat)
20
Studietype
Interventioneel
FASE
N.v.t.
Status
Actief, niet rekruterend
Trefwoorden
Physical activity
Exercise coaching
Exercise coaching
Primaire doel
Ondersteunende zorg
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelExercise 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. |
Actieve comparatorDelayed 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. |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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. | 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. | 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. | At baseline and up to 17 months |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
50 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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
- 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.
Wake Forest University325 actieve klinische studies om te verkennenNationaal Kankerinstituut, VS3030 actieve klinische studies om te verkennenGeen contactgegevens beschikbaar
1 Studielocaties in 1 landen
North Carolina
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, 27157, United States