Fatigue in Breast Cancer Patients Undergoing Radiotherapy-eSMART-MH

Not Applicable

Withdrawn

• Conditions: Breast Cancer
• Interventions: Behavioral: Theater Testing Workshop; Behavioral: eSMART-MH; Other: Mobile Mood Tracking (Mood 24/7)

• Registration Number: NCT02759549
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-11
• Last Update Posted: 2016-11-15
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eSMART-MH	Mobile Mood Tracking (Mood 24/7)	Participants undergoing radiation treatment for breast cancer will receive the Electronic Self-Management Resource Training for Mental Health (eSMART-MH) intervention.
Theater Testing	Theater Testing Workshop	Participants undergoing radiation treatment for breast cancer will participate in a theater testing workshop.
eSMART-MH	eSMART-MH	Participants undergoing radiation treatment for breast cancer will receive the Electronic Self-Management Resource Training for Mental Health (eSMART-MH) intervention.

Primary Outcome Measures

Name	Time	Method
Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score	Baseline, Post Treatment (5-7 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Multidimensional Fatigue Inventory (MFI) Score	Baseline, Post Treatment (5-7 weeks)	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.
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score	Baseline, Post Treatment (5-7 weeks)	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.
Change in Pittsburgh Sleep Quality Index (PSQI) Score	Baseline, Post Treatment (5-7 weeks)	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.
Change in Perceived Stress Scale (PSS) Score	Baseline, Post Treatment (5-7 weeks)	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.
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score	Baseline, Post Treatment (5-7 weeks)	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.
Change in The Centers for Disease Control (CDC) Health-Related Quality of Life-4 (QOL) Questionnaire Score	Baseline, Post Treatment (5-7 weeks)	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.
Change in Short Form-36 (SF-36) Health Survey Score	Baseline, Post Treatment (5-7 weeks)	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.
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score	Baseline, Post Treatment (5-7 weeks)	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.
Change in Lent Soma Scale Patient Questionnaire Score	Baseline, Post Treatment (5-7 weeks)	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.

Trial Locations

Locations (4)

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States