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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
46
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.
Participants in the usual care group will receive no intervention
Hershey Medical Center
Hershey, Pennsylvania, United States
Markers of inflammation: C-reactive protein
A cytokine multiplex will assess markers of inflammation, including C-reactive protein
Time frame: Baseline
Markers of inflammation: C-reactive protein
A cytokine multiplex will assess markers of inflammation, including C-reactive protein
Time frame: 15 weeks
Markers of inflammation-Interleukin 6
A cytokine multiplex will assess markers of inflammation, including Interleukin 6
Time frame: Baseline
Markers of inflammation-Interleukin 6
A cytokine multiplex will assess markers of inflammation, including Interleukin 6
Time frame: 15 weeks
Markers of inflammation-Tumor Necrosis Factor Alpha
A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha
Time frame: Baseline
Markers of inflammation-Tumor Necrosis Factor Alpha
A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha
Time frame: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments scores range from 0-72, higher scores indicate better quality of life.
Time frame: Baseline
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The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments scores range from 0-72, higher scores indicate better quality of life.
Time frame: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life
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.
Time frame: Baseline
The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life
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.
Time frame: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others scores range from 0-16, higher scores indicate better quality of life.
Time frame: Baseline
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others scores range from 0-16, higher scores indicate better quality of life.
Time frame: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities scores range from 0-28, higher scores indicate better quality of life.
Time frame: Baseline
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities scores range from 0-28, higher scores indicate better quality of life.
Time frame: 15 weeks
Anxiety Symptoms-State-Trait Anxiety Inventory
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.
Time frame: Baseline
Anxiety Symptoms-State-Trait Anxiety Inventory
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.
Time frame: 15 weeks
Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System
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
Time frame: Baseline
Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System
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
Time frame: 15 weeks
Depressive Symptoms
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
Time frame: Baseline
Depressive Symptoms
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
Time frame: 15 weeks
Physical Function-The Patient-Reported Outcomes Measurement Information System
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
Time frame: Baseline
Physical Function-The Patient-Reported Outcomes Measurement Information System
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
Time frame: 15 weeks
Fatigue
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.
Time frame: Baseline
Fatigue
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.
Time frame: 15 weeks
Sleep Disturbance
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.
Time frame: Baseline
Sleep Disturbance-PROMIS-57
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.
Time frame: 15 weeks
Ability to Participate in Social Roles and Activities
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
Time frame: baseline
Ability to Participate in Social Roles and Activities
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
Time frame: 15 weeks
Pain interference
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
Time frame: Baseline
Pain interference
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
Time frame: 15 weeks
Pain intensity
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
Time frame: Baseline
Pain intensity
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
Time frame: 15 weeks
Alcohol consumption
A questionnaire probing the number of alcohol drinks consumed in the past 7 days
Time frame: Baseline
Alcohol consumption
A questionnaire probing the number of alcohol drinks consumed in the past 7 days
Time frame: 15 weeks
Physical Function-walk test
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
Time frame: Baseline
Physical Function-walk test
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
Time frame: 15 weeks
Mobile Monitoring of Cognitive Change
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.
Time frame: Week 1-2
Mobile Monitoring of Cognitive Change
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.
Time frame: Week 7-8
Mobile Monitoring of Cognitive Change
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.
Time frame: Week 14-15
Alcohol consumption-daily
Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts
Time frame: Week 1-2
Alcohol consumption-daily
Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts
Time frame: Week 7-8
Alcohol consumption-daily
Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts
Time frame: Week 14-15
Alcohol Use Disorder
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.
Time frame: Baseline
Telephone Interview for Cognitive Status
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
Time frame: Baseline
Demographics
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
Time frame: Baseline
Acceptability-the proportion of older adults who agree to participate
The proportion of older adults who agree to participate among those deemed eligible.
Time frame: Baseline
Feasibility-the proportion of older adults who complete at least 50% of the physical activity intervention
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.
Time frame: Week 15