Clinical trial NCT05156463: The PAI Trial for Breast and Colon Cancer Survivors
Official title: Evaluating a Physical Activity Assessment and Counseling Index for Breast and Colon Cancer Survivors in Clinical Practice (The PAI Trial)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Colon Cancer
Keywords: Adult Cancer Survivors
Geriatrics
Gerontology
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-12-14
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Introduce PAI tool to increase PA and reduce sedentary behavior
timeFrame: 7 days prior to each visit clinical visit (Baseline, 3 months, 6 months, 12 months)
measure: Change in activity as measured by Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire for Older Adults
timeFrame: Baseline, 3 months, 6 months,12 months
measure: Use of Actigraph to measure changes in activity and sedentary behavior
timeFrame: 7 days prior to each clinical visit (Baseline, 3 months, 6 months, 12 months)
Secondary outcomes:
measure: 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
timeFrame: Baseline, 3 months, 6 months,12 months
measure: 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.
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Shirley M Bluethmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: