Clinical trial NCT02759549: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: Radiation Therapy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2016-05-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score
timeFrame: Baseline, Post Treatment (5-7 weeks)
Secondary outcomes:
measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Perceived Stress Scale (PSS) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Short Form-36 (SF-36) Health Survey Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Lent Soma Scale Patient Questionnaire Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Multidimensional Fatigue Inventory (MFI) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in The Centers for Disease Control (CDC) Health-Related Quality of Life-4 (QOL) Questionnaire Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
Other outcomes:
measure: Change in Behavioral Activation for Depression Scale-Short Form (BADS-SF) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Self-Efficacy for Managing Chronic Disease 6-Item Scale Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Pediatric CARE measure 10 questions (PCM 10Q) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Virtual Support Measure Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in The University of California, Los Angeles (UCLA) Loneliness Scale Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Patient Activation Measure (PAM-13) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Quality of Patient-Provider Interaction Questionnaire (QPPI) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Patient Self-Competence Subscale (PSCS) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in FAS Verbal Fluency Test Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in The State Hope Scale Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Emotional Regulation Questionnaire (ERQ) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Body Awareness Questionnaire Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: Change in Experiences Questionnaire (EQ) Score
timeFrame: Baseline, Post Treatment (5-7 weeks)
measure: 3 Item Functional Health Literacy Quick Screen
timeFrame: Baseline
measure: Tobacco Use Questionnaire
timeFrame: Baseline
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline
measure: Adverse Childhood Event (ACE) Questionnaire
timeFrame: Post last intervention (4 week follow up)
Locations:
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University
name: Mylin Torres, MD
role: PRINCIPAL_INVESTIGATOR
References: