Purpose

The Trial Assessing Light-Intensity Exercise on the Health of Older Breast Cancer Survivors pilot randomized controlled trial aims to evaluate the efficacy of a home-based, light-intensity physical activity intervention among 56 obese, older adult breast cancer survivors, in comparison to a usual care control condition.

Conditions

Eligibility

Eligible Ages
Between 65 Years and 84 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Female 2. Age 65-84 years 3. 1-10 years post-breast cancer treatment 4. Body mass index ≥30 5. ≥1 drink per week over the last month 6. ≥21 on the Telephone Interview For Cognitive Status 7. ≤7 on the Alcohol Use Disorder Identification Test 8. Fluent in written and spoken English 9. Must be able to provide and understand informed consent 10. Primary physician approval

Exclusion Criteria

  1. Body mass index <30 2. < 21 on the Telephone Interview for Cognitive Status 3. >7 on the Alcohol Use Disorder Inventory Test 4. Other neurological or major psychiatric disorders 5. Significant heart or lung disease 6. Limited life expectancy 7. Other factors that could potentially limit ability to participate fully in the intervention 8. Self-reporting achieving over 150 minutes of moderate-to-vigorous physical activity per week.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized controlled trial
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Physical activity
the physical activity intervention will be structured to increase light-intensity aerobic physical activity, to achieve a total of 150 minutes per week. The intervention will also include weekly support calls from research staff to improve compliance to physical activity
  • Behavioral: Physical Activity
    The physical activity program will focus on increasing physical activity, starting with a target of 100 minutes per week. The session durations will build over time to 150 minutes per week. Participants will be instructed to walk, or engage in other forms of light-intensity physical activity to achieve these goals. Participants will be instructed on the use of the ratings of perceived exertion scale (6-20). As the participants' health and fitness status improves, frequency, intensity, and session duration will be modified accordingly during weekly support calls. As participants will enter the study engaging in varying levels of physical activity, goals will be responsive to the most recent week's achieved minutes.
Other
Usual care
Participants randomized to the usual care control group will serve as the control group for 15 weeks, and receive no intervention during this time.
  • Other: Usual Care
    Participants in the usual care group will receive no intervention

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Milton S. Hershey Medical Center

Study Contact

Brett R Gordon, PhD
717-531-4314
bgordon1@pennstatehealth.psu.edu

Detailed Description

The investigators will recruit 56 obese, older adult breast cancer survivors at least 1 year, and up to 10 years post-breast cancer treatment, and randomize them to either a 15 week light-intensity physical activity intervention, or usual care group. Intervention: The participants will receive weekly support calls, and instructed to increase their light-intensity physical activity, to achieve at least 150 minutes per week. The frequency, intensity, time, and type of physical activity will be modified to maximize adherence and compliance. The support calls developed for this trial target older adults' capabilities, opportunities, and motivations for physical activity.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.