Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors

NCT ID: NCT04965246

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-22
• Study Completion Date: 2024-07-08

Brief Summary

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.

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.

Conditions

Inflammation; Cognitive Impairment; Anxiety; Alcohol Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: BEHAVIORAL

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.

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.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Participants in the usual care group will receive no intervention

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

Participants in the usual care group will receive no intervention

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christopher Sciamanna, MD, MPH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn Schmitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

PSCI 21-045

Identifier Type: -

Identifier Source: org_study_id