An interventional study of PAI Tool and Exercise Coaching in Breast Cancer and Colon Cancer, sponsored by Milton S. Hershey Medical Center. Withdrawn. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-28.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Supportive care
The purpose of the study is to determine if a Physical Activity Index (PAI) tool that collects measures on physical activity, strength training and sedentary behavior can be used in a clinical setting to monitor patient behavior and provide specific recommendations on how to achieve and maintain behavior goals. The tool will be used after treatment is completed in breast and colon cancer survivors and will test if physician counseling combined with patient self-monitoring improves physical activity and reduces sedentary behavior over time.
1,433 studies on the registry are indexed under Colonic Neoplasms; 358 are open to participants now.
Browse Colonic Neoplasms studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
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Exclusion Criteria:
We will not include any of the following vulnerable populations: adults unable to consent, individuals who are not yet adults, pregnant women, neonates, or prisoners.
Participants will receive standard follow-up survivorship care, an accelerometer to measure physical activity and NCCN (National Comprehensive Cancer Network) patient materials.
Participants will receive same materials as standard of care group. In addition participants will use PAI Activity tool, Garmin activity tracker and exercise logs, and also receive periodic exercise coaching.
Combination Product: PAI Tool and Exercise Coaching
Use of PAI tool and self-monitoring tools to increase physical activity and reduce sedentary behaviors. Participants will receive a personalized physical assessment and counseling from healthcare provider, exercise logs and a Garmin activity tracker to use between visits and 9 exercise coaching calls between clinical visits.
Introduce PAI tool to increase PA and reduce sedentary behavior
PAI Tool: frequency and time spent in strenuous moderate and mild PA over 7 days and self reported television time or sedentary screen time per week
Time frame: 7 days prior to each visit clinical visit (Baseline, 3 months, 6 months, 12 months)
Change in activity as measured by Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire for Older Adults
This self-report questionnaire assesses weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults. Scores are recorded based on number of repetitions the activity was completed and the hours spent doing the activity from less than 1 hour to 9 or more hours.
Time frame: Baseline, 3 months, 6 months,12 months
Use of Actigraph to measure changes in activity and sedentary behavior
Activity patterns and sedentary behavior based on 7 days of wear before clinical visit
Time frame: 7 days prior to each clinical visit (Baseline, 3 months, 6 months, 12 months)
Modified Cancer and Aging Research Group (CARG) plus National Health and Nutrition Examination Survey (NHANES) and Patient-Reported Outcomes Measurement Information System (PROMIS) Geriatric Assessment Study Patient Questionnaire
Aggregated assessment of self-reported information about demographic data, daily activities, nutritional status, medication use and health behaviors.
Time frame: Baseline, 3 months, 6 months,12 months
Exercise Self-Efficacy Scale This scale assesses an individual's beliefs in their ability to continue exercising on a 3 time/week basis at moderate intensities for 40+ min. per session in the future.
For 8 items, participants indicate their confidence to execute the behavior on a 100-pt percentage scale comprised of 10-pt increments, ranging from 0% (not at all confident) to 100% (highly confident).
Time frame: Baseline, 3 months, 6 months, 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center