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

Penn State Health

Status: Completed

Conditions: Inflammation; Cognitive Impairment; Anxiety; Alcohol Drinking

Treatments: Behavioral: Physical Activity; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04965246

PSCI 21-045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: Female

Ages: 65 to 84 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Physical activity

Experimental group

Description:

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

Treatment:

Behavioral: Physical Activity

Usual care

Other group

Description:

Participants randomized to the usual care control group will serve as the control group for 15 weeks, and receive no intervention during this time.

Treatment:

Other: Usual Care