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Fatigue in Breast Cancer Patients Undergoing Radiotherapy-eSMART-MH

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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Withdrawn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)

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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