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Completed

NCT Number: NCT04965246

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

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.

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Key information

Age range

65 year–84 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity

Behavioral

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.

Usual Care

Other

Participants in the usual care group will receive no intervention

Primary outcomes

  1. Markers of inflammation: C-reactive protein

    Time frame: Baseline

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

  2. Markers of inflammation: C-reactive protein

    Time frame: 15 weeks

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

Secondary outcomes

  1. Markers of inflammation-Interleukin 6

    Time frame: Baseline

    A cytokine multiplex will assess markers of inflammation, including Interleukin 6

  2. Markers of inflammation-Interleukin 6

    Time frame: 15 weeks

    A cytokine multiplex will assess markers of inflammation, including Interleukin 6

  3. Markers of inflammation-Tumor Necrosis Factor Alpha

    Time frame: Baseline

    A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha

  4. Markers of inflammation-Tumor Necrosis Factor Alpha

    Time frame: 15 weeks

    A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha

  5. The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments

    Time frame: Baseline

    The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments scores range from 0-72, higher scores indicate better quality of life.

  6. The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments

    Time frame: 15 weeks

    The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments scores range from 0-72, higher scores indicate better quality of life.

  7. The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life

    Time frame: Baseline

    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.

  8. The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life

    Time frame: 15 weeks

    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.

  9. The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others

    Time frame: Baseline

    The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others scores range from 0-16, higher scores indicate better quality of life.

  10. The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others

    Time frame: 15 weeks

    The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others scores range from 0-16, higher scores indicate better quality of life.

  11. The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities

    Time frame: Baseline

    The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities scores range from 0-28, higher scores indicate better quality of life.

  12. The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities

    Time frame: 15 weeks

    The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities scores range from 0-28, higher scores indicate better quality of life.

  13. Anxiety Symptoms-State-Trait Anxiety Inventory

    Time frame: Baseline

    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.

  14. Anxiety Symptoms-State-Trait Anxiety Inventory

    Time frame: 15 weeks

    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. Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System

    Time frame: Baseline

    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

  16. Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System

    Time frame: 15 weeks

    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

  17. Depressive Symptoms

    Time frame: Baseline

    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

  18. Depressive Symptoms

    Time frame: 15 weeks

    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

  19. Physical Function-The Patient-Reported Outcomes Measurement Information System

    Time frame: Baseline

    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

  20. Physical Function-The Patient-Reported Outcomes Measurement Information System

    Time frame: 15 weeks

    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

  21. Fatigue

    Time frame: Baseline

    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.

  22. Fatigue

    Time frame: 15 weeks

    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.

  23. Sleep Disturbance

    Time frame: Baseline

    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.

  24. Sleep Disturbance-PROMIS-57

    Time frame: 15 weeks

    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.

  25. Ability to Participate in Social Roles and Activities

    Time frame: baseline

    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

  26. Ability to Participate in Social Roles and Activities

    Time frame: 15 weeks

    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

  27. Pain interference

    Time frame: Baseline

    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

  28. Pain interference

    Time frame: 15 weeks

    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

  29. Pain intensity

    Time frame: Baseline

    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

  30. Pain intensity

    Time frame: 15 weeks

    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

  31. Alcohol consumption

    Time frame: Baseline

    A questionnaire probing the number of alcohol drinks consumed in the past 7 days

  32. Alcohol consumption

    Time frame: 15 weeks

    A questionnaire probing the number of alcohol drinks consumed in the past 7 days

  33. Physical Function-walk test

    Time frame: Baseline

    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

  34. Physical Function-walk test

    Time frame: 15 weeks

    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

  35. Mobile Monitoring of Cognitive Change

    Time frame: Week 1-2

    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.

  36. Mobile Monitoring of Cognitive Change

    Time frame: Week 7-8

    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.

  37. Mobile Monitoring of Cognitive Change

    Time frame: Week 14-15

    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.

  38. Alcohol consumption-daily

    Time frame: Week 1-2

    Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts

  39. Alcohol consumption-daily

    Time frame: Week 7-8

    Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts

  40. Alcohol consumption-daily

    Time frame: Week 14-15

    Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts

  41. Alcohol Use Disorder

    Time frame: Baseline

    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.

  42. Telephone Interview for Cognitive Status

    Time frame: Baseline

    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

  43. Demographics

    Time frame: Baseline

    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

  44. Acceptability-the proportion of older adults who agree to participate

    Time frame: Baseline

    The proportion of older adults who agree to participate among those deemed eligible.

  45. Feasibility-the proportion of older adults who complete at least 50% of the physical activity intervention

    Time frame: Week 15

    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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Acronym: TALIEHO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2021
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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