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

Primary Purpose

Inflammation, Cognitive Impairment, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Usual Care
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammation

Eligibility Criteria

65 Years - 84 Years (Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hershey Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Physical activity

Usual care

Arm Description

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

Participants randomized to the usual care control group will serve as the control group for 15 weeks, and receive no intervention during this time.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Markers of inflammation-Interleukin 6
A cytokine multiplex will assess markers of inflammation, including Interleukin 6
Markers of inflammation-Interleukin 6
A cytokine multiplex will assess markers of inflammation, including Interleukin 6
Markers of inflammation-Tumor Necrosis Factor Alpha
A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha
Markers of inflammation-Tumor Necrosis Factor Alpha
A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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.
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.
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.
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.
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
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
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
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
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
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
Alcohol consumption
A questionnaire probing the number of alcohol drinks consumed in the past 7 days
Alcohol consumption
A questionnaire probing the number of alcohol drinks consumed in the past 7 days
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
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
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.
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.
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.
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
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
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
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.
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
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
Acceptability-the proportion of older adults who agree to participate
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
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.

Full Information

First Posted
July 7, 2021
Last Updated
January 3, 2023
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04965246
Brief Title
Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors
Acronym
TALIEHO
Official Title
Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Cognitive Impairment, Anxiety, Alcohol Drinking

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
Other
Arm Description
Participants randomized to the usual care control group will serve as the control group for 15 weeks, and receive no intervention during this time.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Participants in the usual care group will receive no intervention
Primary Outcome Measure Information:
Title
Markers of inflammation: C-reactive protein
Description
A cytokine multiplex will assess markers of inflammation, including C-reactive protein
Time Frame
Baseline
Title
Markers of inflammation: C-reactive protein
Description
A cytokine multiplex will assess markers of inflammation, including C-reactive protein
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Markers of inflammation-Interleukin 6
Description
A cytokine multiplex will assess markers of inflammation, including Interleukin 6
Time Frame
Baseline
Title
Markers of inflammation-Interleukin 6
Description
A cytokine multiplex will assess markers of inflammation, including Interleukin 6
Time Frame
15 weeks
Title
Markers of inflammation-Tumor Necrosis Factor Alpha
Description
A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha
Time Frame
Baseline
Title
Markers of inflammation-Tumor Necrosis Factor Alpha
Description
A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha
Time Frame
15 weeks
Title
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments
Description
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
Title
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments
Description
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
Title
The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life
Description
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
Title
The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life
Description
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
Title
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others
Description
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
Title
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others
Description
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
Title
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities
Description
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
Title
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities
Description
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
Title
Anxiety Symptoms-State-Trait Anxiety Inventory
Description
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
Title
Anxiety Symptoms-State-Trait Anxiety Inventory
Description
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
Title
Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System
Description
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
Title
Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System
Description
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
Title
Depressive Symptoms
Description
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
Title
Depressive Symptoms
Description
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
Title
Physical Function-The Patient-Reported Outcomes Measurement Information System
Description
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
Title
Physical Function-The Patient-Reported Outcomes Measurement Information System
Description
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
Title
Fatigue
Description
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
Title
Fatigue
Description
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
Title
Sleep Disturbance
Description
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
Title
Sleep Disturbance-PROMIS-57
Description
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
Title
Ability to Participate in Social Roles and Activities
Description
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
Title
Ability to Participate in Social Roles and Activities
Description
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
Title
Pain interference
Description
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
Title
Pain interference
Description
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
Title
Pain intensity
Description
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
Title
Pain intensity
Description
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
Title
Alcohol consumption
Description
A questionnaire probing the number of alcohol drinks consumed in the past 7 days
Time Frame
Baseline
Title
Alcohol consumption
Description
A questionnaire probing the number of alcohol drinks consumed in the past 7 days
Time Frame
15 weeks
Title
Physical Function-walk test
Description
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
Title
Physical Function-walk test
Description
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
Title
Mobile Monitoring of Cognitive Change
Description
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
Title
Mobile Monitoring of Cognitive Change
Description
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
Title
Mobile Monitoring of Cognitive Change
Description
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
Title
Alcohol consumption-daily
Description
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
Title
Alcohol consumption-daily
Description
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
Title
Alcohol consumption-daily
Description
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
Title
Alcohol Use Disorder
Description
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
Title
Telephone Interview for Cognitive Status
Description
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
Title
Demographics
Description
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
Title
Acceptability-the proportion of older adults who agree to participate
Description
The proportion of older adults who agree to participate among those deemed eligible.
Time Frame
Baseline
Title
Feasibility-the proportion of older adults who complete at least 50% of the physical activity intervention
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brett R Gordon, PhD
Phone
717-531-4314
Ext
x4314
Email
bgordon1@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Schmitz, PhD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett R Gordon, PhD
Phone
717-531-4314
Email
bgordon1@phs.psu.edu

12. IPD Sharing Statement

Learn more about this trial

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

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