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

Not Applicable

Completed

• Conditions: Cognitive Impairment; Inflammation; Anxiety; Alcohol Drinking
• Interventions: Other: Usual Care; Behavioral: Physical Activity

• Registration Number: NCT04965246
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-16
• Study Start: 2021-11-22
• Primary Completion: 2024-07-08
• Study Completion: 2024-07-08
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	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.
Physical activity	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

Primary Outcome Measures

Name	Time	Method
Markers of inflammation: C-reactive protein	15 weeks	A cytokine multiplex will assess markers of inflammation, including C-reactive protein

Secondary Outcome Measures

Name	Time	Method
Fatigue	15 weeks	The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - fatigue subscale measures patient reported fatigue. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher fatigue.
Sleep Disturbance	Baseline	The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Sleep Disturbance subscale measures patient reported Sleep Disturbance. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviationof 10. Higher scores indicate higher Sleep Disturbance.
Ability to Participate in Social Roles and Activities	15 weeks	The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Ability to Participate in Social Roles and Activities subscale measures patient reported Ability to Participate in Social Roles and Activities. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Ability to Participate in Social Roles and Activities
Physical Function-walk test	15 weeks	The six minute walking test will be administered to assess physical function. Participants will aim to walk as far as possible for 6 minutes.; Further distances indicate greater physical function
Depressive Symptoms	15 weeks	The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - depression subscale measures patient reported depressive symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher depression
Physical Function-The Patient-Reported Outcomes Measurement Information System	15 weeks	The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - physical function subscale measures patient reported physical function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher physical function
Pain intensity	15 weeks	The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain intensity
Anxiety Symptoms-State-Trait Anxiety Inventory	15 weeks	State and trait anxiety are measured using the State and Trait subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol).The State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the subscales. State-Trait Anxiety Inventory varies from a minimum score of 20 to a maximum score of 80, higher scores indicate higher anxiety.
Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System	15 weeks	The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Anxiety subscale measures patient reported anxiety symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher anxiety
Pain interference	15 weeks	The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain interference
Alcohol consumption	15 weeks	A questionnaire probing the number of alcohol drinks consumed in the past 7 days
Mobile Monitoring of Cognitive Change	Week 14-15	Ecological momentary assessment procedures for measuring both self-report and objective cognitive function will be used in 14 day bursts. These ecological momentary assessments protocols assess many of the same domains captured in other self-report and objective cognitive function measures, shortened and adapted for daily assessments.
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments	15 weeks	The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments scores range from 0-72, higher scores indicate better quality of life.
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities	15 weeks	The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities scores range from 0-28, higher scores indicate better quality of life.
Markers of inflammation-Interleukin 6	15 weeks	A cytokine multiplex will assess markers of inflammation, including Interleukin 6
Markers of inflammation-Tumor Necrosis Factor Alpha	15 weeks	A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha
The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life	15 weeks	The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life scores range from 0-16, higher scores indicate better quality of life.
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others	15 weeks	The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others scores range from 0-16, higher scores indicate better quality of life.
Sleep Disturbance-PROMIS-57	15 weeks	The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Sleep Disturbance subscale measures patient reported Sleep Disturbance. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Sleep Disturbance.
Telephone Interview for Cognitive Status	Baseline	The Telephone Interview for Cognitive Status is a brief, standardized test of cognitive functioning that was developed for use in situations where in-person cognitive screening is impractical or inefficient. The Telephone Interview for Cognitive Status will be used to screen for moderate-to-severe cognitive impairment. Scores 20 of lower indicate moderate-to-severe cognitive impairment
Demographics	Baseline	Age, height, weight, family income, education level, age at diagnosis, time since diagnosis, injury history, diabetic status, and whether they are currently receiving treatment for mental health will be assessed at baseline
Alcohol consumption-daily	Week 14-15	Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts
Alcohol Use Disorder	Baseline	The Alcohol Use Disorders Identification Test is a simple and effective method of screening for unhealthy alcohol use, defined as risky or hazardous consumption or any alcohol use disorder. A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.
Acceptability-the proportion of older adults who agree to participate	Baseline	The proportion of older adults who agree to participate among those deemed eligible.
Feasibility-the proportion of older adults who complete at least 50% of the physical activity intervention	Week 15	The percentage of those randomized to the physical activity intervention that complete at least 50% of the physical activity intervention. Participants will be instructed by a project manager during weekly support calls to accumulate a specific amount of physical activity each week. Participants who self-report completing at least 50% of the physical activity, determined by the physical activity log, will be deemed compliant.

Trial Locations

Locations (1)

Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States