The PAI Trial for Breast and Colon Cancer Survivors

NCT05156463 | Withdrawn DMC

• 1 other identifier: STUDY00018917
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Colon Cancer

Keywords

Adult Cancer Survivors; Geriatrics; Gerontology

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Control

NO INTERVENTION

Participants will receive standard follow-up survivorship care, an accelerometer to measure physical activity and NCCN (National Comprehensive Cancer Network) patient materials.

Treatment

EXPERIMENTAL

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

Interventions

PAI Tool and Exercise Coaching COMBINATION_PRODUCT

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.

Treatment

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Female breast cancer survivors Female/Male colon cancer survivors
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Shirley M Bluethmann, PhD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 14, 2021
• Study Start: April 12, 2022
• Primary Completion: April 12, 2022
• Study Completion: April 12, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share