Fatigue in Breast Cancer Patients Undergoing Radiotherapy-eSMART-MH

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fatigue in Breast Cancer Patients Undergoing Radiotherapy-Electronic Self-Management Resource Training for Mental Health (eSMART-MH)

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: eSMART-MH
* Other: Mobile Mood Tracking (Mood 24/7)
* Behavioral: Theater Testing Workshop


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eSMART-MH<br>Participants undergoing radiation treatment for breast cancer will receive the Electronic Self-Management Resource Training for Mental Health (eSMART-MH) intervention. | Behavioral: eSMART-MH<br>* 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.<br>Other: Mobile Mood Tracking (Mood 24/7)<br>* 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.<br>|
| Other: Theater Testing<br>Participants undergoing radiation treatment for breast cancer will participate in a theater testing workshop. | Behavioral: Theater Testing Workshop<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Post Treatment (5-7 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Post Treatment (5-7 weeks) | 
| 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. | Baseline, Post Treatment (5-7 weeks) | 
| 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. | Baseline, Post Treatment (5-7 weeks) | 
| 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. | Baseline, Post Treatment (5-7 weeks) | 
| 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. | Baseline, Post Treatment (5-7 weeks) | 
| 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. | Baseline, Post Treatment (5-7 weeks) | 
| 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. | Baseline, Post Treatment (5-7 weeks) | 
| 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. | Baseline, Post Treatment (5-7 weeks) | 
| 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. | Baseline, Post Treatment (5-7 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation Therapy