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

NCT04965246 | Completed

• 1 other identifier: PSCI 21-045
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Cognitive Impairment; Anxiety; Alcohol Drinking

Outcome Measures

Primary Outcomes (2)

• Markers of inflammation: C-reactive protein

  A cytokine multiplex will assess markers of inflammation, including C-reactive protein

  Baseline

• Markers of inflammation: C-reactive protein

  A cytokine multiplex will assess markers of inflammation, including C-reactive protein

  15 weeks

Secondary Outcomes (45)

• Markers of inflammation-Interleukin 6

  Baseline

• Markers of inflammation-Interleukin 6

  15 weeks

• Markers of inflammation-Tumor Necrosis Factor Alpha

  Baseline

• Markers of inflammation-Tumor Necrosis Factor Alpha

  15 weeks

• The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments

  Baseline

Study Arms (2)

Physical activity

EXPERIMENTAL

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

Usual care

OTHER

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

Interventions

Physical Activity 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.

Physical activity

Usual Care OTHER

Participants in the usual care group will receive no intervention

Usual care

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Inflammation; Cognitive Dysfunction; Anxiety Disorders; Alcohol Drinking

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kathryn Schmitz, PhD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: November 22, 2021
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)