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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
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.
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.
Emory Clinic
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Winship Cancer Institute
Atlanta, Georgia, United States
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.
Time frame: Baseline, Post Treatment (5-7 weeks)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Post Treatment (5-7 weeks)
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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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Post Treatment (5-7 weeks)