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

Anxiety Clinical Trial

— TALIEHO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04965246
• Other study ID #: PSCI 21-045
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Milton S. Hershey Medical Center
• Contact: Brett R Gordon, PhD
• Phone: 717-531-4314
• Email: bgordon1[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Anxiety
• Cognitive Impairment
• Inflammation

Intervention

Behavioral:
• Physical Activity
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.

Other:
• Usual Care
Participants in the usual care group will receive no intervention

Locations

Country	Name	City	State
United States	Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Markers of inflammation: C-reactive protein	A cytokine multiplex will assess markers of inflammation, including C-reactive protein	Baseline
Primary	Markers of inflammation: C-reactive protein	A cytokine multiplex will assess markers of inflammation, including C-reactive protein	15 weeks
Secondary	Markers of inflammation-Interleukin 6	A cytokine multiplex will assess markers of inflammation, including Interleukin 6	Baseline
Secondary	Markers of inflammation-Interleukin 6	A cytokine multiplex will assess markers of inflammation, including Interleukin 6	15 weeks
Secondary	Markers of inflammation-Tumor Necrosis Factor Alpha	A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha	Baseline
Secondary	Markers of inflammation-Tumor Necrosis Factor Alpha	A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha	15 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Alcohol consumption	A questionnaire probing the number of alcohol drinks consumed in the past 7 days	Baseline
Secondary	Alcohol consumption	A questionnaire probing the number of alcohol drinks consumed in the past 7 days	15 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Acceptability-the proportion of older adults who agree to participate	The proportion of older adults who agree to participate among those deemed eligible.	Baseline
Secondary	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