The PAI Trial for Breast and Colon Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Evaluating a Physical Activity Assessment and Counseling Index for Breast and Colon Cancer Survivors in Clinical Practice (The PAI Trial)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05156463
• Other study ID #: STUDY00018917
• Status: Withdrawn
• Phase: N/A
• Start date: April 12, 2022
• Est. completion date: April 12, 2022

Study information

• Verified date: April 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 12, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Colonic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days prior to each visit clinical visit (Baseline, 3 months, 6 months, 12 months)
Primary	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.	Baseline, 3 months, 6 months,12 months
Primary	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	7 days prior to each clinical visit (Baseline, 3 months, 6 months, 12 months)
Secondary	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.	Baseline, 3 months, 6 months,12 months
Secondary	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).	Baseline, 3 months, 6 months, 12 months