Fatigue in Breast Cancer Patients Undergoing Radiotherapy-eSMART-MH

Emory University

Status: Withdrawn

Conditions: Breast Cancer

Treatments: Behavioral: Theater Testing Workshop; Other: Mobile Mood Tracking (Mood 24/7); Behavioral: eSMART-MH

Study type: Interventional

Funder types: Other

Identifiers

NCT02759549

IRB00028295

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

eSMART-MH

Experimental group

Description:

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

Treatment:

Behavioral: eSMART-MH

Other: Mobile Mood Tracking (Mood 24/7)

Theater Testing

Other group

Description:

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

Treatment:

Behavioral: Theater Testing Workshop