The PAI Trial for Breast and Colon Cancer Survivors

Penn State Health

Status: Withdrawn

Conditions: Breast Cancer; Colon Cancer

Treatments: Combination Product: PAI Tool and Exercise Coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05156463

STUDY00018917

Details and patient eligibility

About

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.

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Control

No Intervention group

Description:

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

Treatment

Experimental group

Description:

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.

Treatment:

Combination Product: PAI Tool and Exercise Coaching