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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammation, Cognitive Impairment, Anxiety, Alcohol Drinking

Intervention / Treatment
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* Behavioral: Physical Activity
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age 65-84 years 1-10 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity<br>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<br>* 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.<br>|
| Other: Usual care<br>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<br>* Participants in the usual care group will receive no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of inflammation-Interleukin 6 | A cytokine multiplex will assess markers of inflammation, including Interleukin 6 | Baseline | 
| Markers of inflammation-Interleukin 6 | A cytokine multiplex will assess markers of inflammation, including Interleukin 6 | 15 weeks | 
| Markers of inflammation-Tumor Necrosis Factor Alpha | A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha | Baseline | 
| Markers of inflammation-Tumor Necrosis Factor Alpha | A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha | 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. | Baseline | 
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 15 weeks | 
| Alcohol consumption | A questionnaire probing the number of alcohol drinks consumed in the past 7 days | Baseline | 
| Alcohol consumption | A questionnaire probing the number of alcohol drinks consumed in the past 7 days | 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 | 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 | 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. | 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. | 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. | 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 | 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 | 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 | 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. | 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 | 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 | Baseline | 
| Acceptability-the proportion of older adults who agree to participate | The proportion of older adults who agree to participate among those deemed eligible. | 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. | Week 15 |