Evaluating a Physical Activity Assessment and Counseling Index for Breast and Colon Cancer Survivors in Clinical Practice (The PAI Trial)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Milton S. Hershey Medical Center
- Primary Endpoint
- Use of Actigraph to measure changes in activity and sedentary behavior
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Shirley Bluethmann
Assistant Professor
Milton S. Hershey Medical Center
Eligibility Criteria
Inclusion Criteria
- •Women ages 60 years or older diagnosed with breast cancer and women or men ages 60 years or older diagnosed with colon cancer within the last 5 years
- •≥ 3 months post-completion of last prescribed treatment (i.e., Chemotherapy, radiation therapy or surgery)
- •Stages I-III (no stage 0 or metastatic cases will be included)
- •Able to understand spoken and written instructions in English
- •Participate in 60 minutes or more of MVPA (moderate to vigorous-intensity physical activity)/week for previous 6 months
- •Have internet access or access to data sharing plan
- •Willing to come to four Penn State Health visits over the course of a year, completing requested questionnaires
- •Willing to use Garmin Vivofit device, participate in exercise coaching sessions and complete exercise logs between visits
Exclusion Criteria
- •Prior respiratory, joint or cardiovascular problems precluding PA
- •Metastatic disease
- •Planned elective surgery during intervention/follow-up
- •Exhibit gross cognitive impairment
- •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.
Outcomes
Primary Outcomes
Use of Actigraph to measure changes in activity and sedentary behavior
Time Frame: 7 days prior to each clinical visit (Baseline, 3 months, 6 months, 12 months)
Activity patterns and sedentary behavior based on 7 days of wear before clinical visit
Introduce PAI tool to increase PA and reduce sedentary behavior
Time Frame: 7 days prior to each visit clinical visit (Baseline, 3 months, 6 months, 12 months)
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
Change in activity as measured by Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire for Older Adults
Time Frame: Baseline, 3 months, 6 months,12 months
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.
Secondary Outcomes
- 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.(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(Baseline, 3 months, 6 months,12 months)