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Fatigue in Breast Cancer Patients Undergoing Radiotherapy-eSMART-MH

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eSMART-MH
Mobile Mood Tracking (Mood 24/7)
Theater Testing Workshop
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Radiation Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients seen in the Emory Breast Center at The Emory Clinic and Emory Midtown Hospital who are treated with curative intent.
  • Score of 8 or higher on the Inventory of Depressive Symptomology - Self Reported (IDS-SR) test

Sites / Locations

  • Emory Clinic
  • Emory University Hospital Midtown
  • Emory University Hospital
  • Winship Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

eSMART-MH

Theater Testing

Arm Description

Participants undergoing radiation treatment for breast cancer will receive the Electronic Self-Management Resource Training for Mental Health (eSMART-MH) intervention.

Participants undergoing radiation treatment for breast cancer will participate in a theater testing workshop.

Outcomes

Primary Outcome Measures

Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score
The IDS-SR is a self-reported measure in which participants rate the frequency of depression symptoms within the past seven days. Scores range from 0 to 84, with higher score reflecting greater severity of depressive symptoms.

Secondary Outcome Measures

Change in Pittsburgh Sleep Quality Index (PSQI) Score
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Scores range from 0 to 21. A score of less than or equal to 5 is associated with good sleep quality. A score greater than 5 is associated with poor sleep quality.
Change in Perceived Stress Scale (PSS) Score
The PSS is a self-reported instrument used to measure the perception of stress. Scores range from 0 to 40. Score of 20 or higher are considered high stress.
Change in Short Form-36 (SF-36) Health Survey Score
The SF-36 is a self-reported survey of health status. Scores range from 0 to 100. Lower scores indicate disability. The higher the score, the less disability.
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
The GLTEQ is a self-reported questionnaire used to measure usual leisure-time exercise habits during a typical seven day period. A score of 24 or more indicates active and substantial exercise benefits. A score of 23 units or less indicates insufficiently active and less substantial exercise benefits.
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score
The PROMIS Fatigue questionnaire is a self-report tool used to evaluate frequency, duration, and intensity of fatigue over the past seven days. Scores range from 7 to 35. The higher the score, the more fatigue.
Change in Lent Soma Scale Patient Questionnaire Score
The Lent Soma questionnaire is a self-reported measure of pain. Scores range from 0 to 9. The higher the score, the more pain reported.
Change in Multidimensional Fatigue Inventory (MFI) Score
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. Scores range from 20 to 100.The higher the score, the more fatigued.
Change in The Centers for Disease Control (CDC) Health-Related Quality of Life-4 (QOL) Questionnaire Score
Quality of Life will be measured by the Center for Disease Control Health Related Quality of Life-4 (CDC HRQOL). This self-report measures quality of life over the last 30 days in the domains of physical and mental health.
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
The FACT-G is a self-reported measure of well being in the past seven days. Scores range from 0 to 27. A higher score indicates worse perception of well being.

Full Information

First Posted
April 29, 2016
Last Updated
November 11, 2016
Sponsor
Emory University
Collaborators
Susan G. Komen Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02759549
Brief Title
Fatigue in Breast Cancer Patients Undergoing Radiotherapy-eSMART-MH
Official Title
Fatigue in Breast Cancer Patients Undergoing Radiotherapy-Electronic Self-Management Resource Training for Mental Health (eSMART-MH)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Susan G. Komen Breast Cancer Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if an avatar-based depression self-management intervention (eSMART-MH) once a week for the duration of the participant's radiation treatment will significantly reduce depressive symptoms. Investigators also seek to explore how women with breast cancer describe their mood using prompted and unprompted speech through electronic social media and interviews. Participants will be randomized into the eSMART-MH group or the theater testing (attention control) group. In addition to the assigned interventions, participants will be asked to complete questionnaires and interviews with the study staff.
Detailed Description
The purpose of this study is to determine if an avatar-based depression self-management intervention (eSMART-MH) once a week for the duration of the participant's radiation treatment will significantly reduce depressive symptoms. Investigators also seek to explore how women with breast cancer describe their mood using prompted and unprompted speech through electronic social media and interviews. Participants will be randomized into the eSMART-MH group or the theater testing (attention control) group. In addition to the assigned interventions, participants will be asked to complete questionnaires and interviews with the study staff. Participants will be enrolled within two weeks of radiotherapy. A preliminary depression survey (IDS-SR) will be given to assess depression. There will be a total of three routine study assessments, one within two weeks prior to the beginning of radiotherapy, one the last week of radiotherapy and one 5 - 7 weeks after radiotherapy is completed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Radiation Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eSMART-MH
Arm Type
Experimental
Arm Description
Participants undergoing radiation treatment for breast cancer will receive the Electronic Self-Management Resource Training for Mental Health (eSMART-MH) intervention.
Arm Title
Theater Testing
Arm Type
Other
Arm Description
Participants undergoing radiation treatment for breast cancer will participate in a theater testing workshop.
Intervention Type
Behavioral
Intervention Name(s)
eSMART-MH
Intervention Description
eSMART-MH (Electronic Self-Management Resource Training for Mental Health) is a software, which is set in a 3-D virtual primary care office environment in which a subject interacts with avatar virtual healthcare staff (medical receptionist, medical assistant, providers, and a virtual healthcare coach). The avatars are programmed to behave like humans. The subject moves through the 3-D virtual primary care office and encounters virtual healthcare staff and providers. The subject practices discussing depressive symptoms with avatar healthcare providers and practices self-management skills related to symptoms of depression.The subject also interacts with the health care coach. The health care coach provides the subject with real-time strategies to enhance communication with healthcare providers during their virtual office visit. eSMART-MH will be used once a week throughout the duration of radiation treatment.
Intervention Type
Other
Intervention Name(s)
Mobile Mood Tracking (Mood 24/7)
Intervention Description
Public social media data posted by participants will be accessed and downloaded to a computer program. Permission for the study team to access this data is optional.
Intervention Type
Behavioral
Intervention Name(s)
Theater Testing Workshop
Intervention Description
The theater testing workshop consists of one to two one-on-one sessions with study staff during which participants will review a computer program for its content and usability, as well as discuss areas for improvement. Participants will also be asked to complete questionnaires and a attend a brief interview regarding any suggested improvements for the computer program.
Primary Outcome Measure Information:
Title
Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score
Description
The IDS-SR is a self-reported measure in which participants rate the frequency of depression symptoms within the past seven days. Scores range from 0 to 84, with higher score reflecting greater severity of depressive symptoms.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Secondary Outcome Measure Information:
Title
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Description
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Scores range from 0 to 21. A score of less than or equal to 5 is associated with good sleep quality. A score greater than 5 is associated with poor sleep quality.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Perceived Stress Scale (PSS) Score
Description
The PSS is a self-reported instrument used to measure the perception of stress. Scores range from 0 to 40. Score of 20 or higher are considered high stress.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Short Form-36 (SF-36) Health Survey Score
Description
The SF-36 is a self-reported survey of health status. Scores range from 0 to 100. Lower scores indicate disability. The higher the score, the less disability.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
Description
The GLTEQ is a self-reported questionnaire used to measure usual leisure-time exercise habits during a typical seven day period. A score of 24 or more indicates active and substantial exercise benefits. A score of 23 units or less indicates insufficiently active and less substantial exercise benefits.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score
Description
The PROMIS Fatigue questionnaire is a self-report tool used to evaluate frequency, duration, and intensity of fatigue over the past seven days. Scores range from 7 to 35. The higher the score, the more fatigue.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Lent Soma Scale Patient Questionnaire Score
Description
The Lent Soma questionnaire is a self-reported measure of pain. Scores range from 0 to 9. The higher the score, the more pain reported.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Multidimensional Fatigue Inventory (MFI) Score
Description
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. Scores range from 20 to 100.The higher the score, the more fatigued.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in The Centers for Disease Control (CDC) Health-Related Quality of Life-4 (QOL) Questionnaire Score
Description
Quality of Life will be measured by the Center for Disease Control Health Related Quality of Life-4 (CDC HRQOL). This self-report measures quality of life over the last 30 days in the domains of physical and mental health.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
Description
The FACT-G is a self-reported measure of well being in the past seven days. Scores range from 0 to 27. A higher score indicates worse perception of well being.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Other Pre-specified Outcome Measures:
Title
Change in Behavioral Activation for Depression Scale-Short Form (BADS-SF) Score
Description
The BADS-SF is a 9-item self-report measures that assess behavioral activation which captures the domains of activation, avoidance/rumination, work/school impairment, and social impairment. The BADS-SF asks participants to respond to each statement over the past week, including the day in which they complete the measure, on a 0 to 6 likert type scale.The BADS-SF has shown to be significantly associated with depression.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Self-Efficacy for Managing Chronic Disease 6-Item Scale Score
Description
The Self-Efficacy for Managing Chronic Disease questionnaire is a six item self-report scale. This measure asks how confident, on a scale of 1-10, the respondent is in doing certain activities pertaining to self-management. Scores range from 6 to 60. A higher score indicates more confidence.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Pediatric CARE measure 10 questions (PCM 10Q) Score
Description
The PCM 10Q is used to gain the views of children or patients receiving health services. It is a patient-centered measure of relational empathy. It measures patients' experiences of the interpersonal aspects of clinical encounters.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Virtual Support Measure Score
Description
The virtual support questionnaire is a measure of perceived virtual support of the avatars. Participants rate the "virtual support" provided by the avatar healthcare provider and avatar coach separately. The first 12 questions of the Virtual Support Questionnaire ask participants to rate, on a Likert-type format, the avatars on a variety of relational characteristics. Selection options range from (1) "No, not at all" to (5) "Yes, definitely." The last 10 items of the Virtual Support Questionnaire ask respondents to rate, using a Likert-type format, to what degree they agree or disagree with statements about how the avatars understood their experiences. Selection options ranged from (1) "Strongly agree" to (6) "Strongly disagree."
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in The University of California, Los Angeles (UCLA) Loneliness Scale Score
Description
The UCLA Loneliness Scale is a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as either O ("I often feel this way"),S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). A higher score indicates more feelings of loneliness.This scale has a strong association with depression.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Patient Activation Measure (PAM-13) Score
Description
The PAM-13 is a 13-item measure that assesses the patient's perception of their knowledge, skill, and confidence in self-management behavior. Scores range from 0-100, with a higher score indicating greater patient activation.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Quality of Patient-Provider Interaction Questionnaire (QPPI) Score
Description
The QPPI is a 14-item self-report likert type style questionnaire that assesses from the patient's perspective the quality of the interaction between the patient provider.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Patient Self-Competence Subscale (PSCS) Score
Description
A 16-item five point Likert scale that asks participants to rate items from 5 (important) to 1 (unimportant); a higher score indicates greater perceived self-competence and effective communication with a health care provider.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in FAS Verbal Fluency Test Score
Description
The FAS Verbal Fluency Test task asks respondents to generate words beginning with the letters "F," "A," and "S" within 60 seconds. Adults with depression generate fewer words on the FAS than non-depressed.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in The State Hope Scale Score
Description
The State Hope Scale is a a 6-item self-report scale which measures goal-directed thinking and the "here and now." Respondents are asked to respond to items in relation to what is "going on in your life right now" in response to goal-directed statements on a 1-8 scale.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Emotional Regulation Questionnaire (ERQ) Score
Description
The ERQ is a 20-item scale that asks respondents how they manage and regulate their emotions in response to life events on a 1-7 likert-type scale.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Body Awareness Questionnaire Score
Description
The Body Awareness Questionnaire is a an 18-item measure that asks respondents to rate their sensitivity to normal and non-emotional body processes on a 1-7 likert-type scale.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
Change in Experiences Questionnaire (EQ) Score
Description
The EQ is a 20 item self-report scale designed to measure decentering and deep thinking.
Time Frame
Baseline, Post Treatment (5-7 weeks)
Title
3 Item Functional Health Literacy Quick Screen
Description
The 3 Item Functional Health Literacy Quick Screen is used to detect limited and marginal health literacy skills.
Time Frame
Baseline
Title
Tobacco Use Questionnaire
Description
The Tobacco Use Questionnaire is two question self-report about the use of traditional cigarettes, or e-cigarettes, or both and the amount of cigarettes smoked.
Time Frame
Baseline
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
The AUDIT simple brief assessment tool to screen for excessive drinking. The measure consists of 10 questions about recent alcohol use, alcohol dependence symptoms, and alcohol-related problems.
Time Frame
Baseline
Title
Adverse Childhood Event (ACE) Questionnaire
Description
An ACE score is a tally of different types of abuse, neglect, and household dysfunction. There are 10 items on the measure; we will ask 9 of these questions, omitting the question about sexual abuse. The ACE Study emphasizes the number rather than categories of ACE that one has been subjected to. The number of the nine items of ACE that one has undergone (0-9) is regarded as the ACE score.
Time Frame
Post last intervention (4 week follow up)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients seen in the Emory Breast Center at The Emory Clinic and Emory Midtown Hospital who are treated with curative intent. Score of 8 or higher on the Inventory of Depressive Symptomology - Self Reported (IDS-SR) test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mylin Torres, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fatigue in Breast Cancer Patients Undergoing Radiotherapy-eSMART-MH

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