Clinical trial NCT04965246: Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors
Official title: Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Cognitive Impairment
Anxiety
Alcohol Drinking
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 46
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Markers of inflammation: C-reactive protein
timeFrame: Baseline
measure: Markers of inflammation: C-reactive protein
timeFrame: 15 weeks
Secondary outcomes:
measure: Markers of inflammation-Interleukin 6
timeFrame: Baseline
measure: Markers of inflammation-Interleukin 6
timeFrame: 15 weeks
measure: Markers of inflammation-Tumor Necrosis Factor Alpha
timeFrame: Baseline
measure: Markers of inflammation-Tumor Necrosis Factor Alpha
timeFrame: 15 weeks
measure: The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments
timeFrame: Baseline
measure: The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments
timeFrame: 15 weeks
measure: The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life
timeFrame: Baseline
measure: The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life
timeFrame: 15 weeks
measure: The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others
timeFrame: Baseline
measure: The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others
timeFrame: 15 weeks
measure: The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities
timeFrame: Baseline
measure: The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities
timeFrame: 15 weeks
measure: Anxiety Symptoms-State-Trait Anxiety Inventory
timeFrame: Baseline
measure: Anxiety Symptoms-State-Trait Anxiety Inventory
timeFrame: 15 weeks
measure: Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System
timeFrame: Baseline
measure: Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System
timeFrame: 15 weeks
measure: Depressive Symptoms
timeFrame: Baseline
measure: Depressive Symptoms
timeFrame: 15 weeks
measure: Physical Function-The Patient-Reported Outcomes Measurement Information System
timeFrame: Baseline
measure: Physical Function-The Patient-Reported Outcomes Measurement Information System
timeFrame: 15 weeks
measure: Fatigue
timeFrame: Baseline
measure: Fatigue
timeFrame: 15 weeks
measure: Sleep Disturbance
timeFrame: Baseline
measure: Sleep Disturbance-PROMIS-57
timeFrame: 15 weeks
measure: Ability to Participate in Social Roles and Activities
timeFrame: baseline
measure: Ability to Participate in Social Roles and Activities
timeFrame: 15 weeks
measure: Pain interference
timeFrame: Baseline
measure: Pain interference
timeFrame: 15 weeks
measure: Pain intensity
timeFrame: Baseline
measure: Pain intensity
timeFrame: 15 weeks
measure: Alcohol consumption
timeFrame: Baseline
measure: Alcohol consumption
timeFrame: 15 weeks
measure: Physical Function-walk test
timeFrame: Baseline
measure: Physical Function-walk test
timeFrame: 15 weeks
measure: Mobile Monitoring of Cognitive Change
timeFrame: Week 1-2
measure: Mobile Monitoring of Cognitive Change
timeFrame: Week 7-8
measure: Mobile Monitoring of Cognitive Change
timeFrame: Week 14-15
measure: Alcohol consumption-daily
timeFrame: Week 1-2
measure: Alcohol consumption-daily
timeFrame: Week 7-8
measure: Alcohol consumption-daily
timeFrame: Week 14-15
measure: Alcohol Use Disorder
timeFrame: Baseline
measure: Telephone Interview for Cognitive Status
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
measure: Acceptability-the proportion of older adults who agree to participate
timeFrame: Baseline
measure: Feasibility-the proportion of older adults who complete at least 50% of the physical activity intervention
timeFrame: Week 15
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Kathryn Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: