Fatigue in Breast Cancer Patients Undergoing Radiotherapy-Electronic Self-Management Resource Training for Mental Health (eSMART-MH)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 8
- 主要终点
- Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score
时间窗: 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.
次要结局
- Change in Multidimensional Fatigue Inventory (MFI) Score(Baseline, Post Treatment (5-7 weeks))
- Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score(Baseline, Post Treatment (5-7 weeks))
- Change in Pittsburgh Sleep Quality Index (PSQI) Score(Baseline, Post Treatment (5-7 weeks))
- Change in Perceived Stress Scale (PSS) Score(Baseline, Post Treatment (5-7 weeks))
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score(Baseline, Post Treatment (5-7 weeks))
- Change in The Centers for Disease Control (CDC) Health-Related Quality of Life-4 (QOL) Questionnaire Score(Baseline, Post Treatment (5-7 weeks))
- Change in Short Form-36 (SF-36) Health Survey Score(Baseline, Post Treatment (5-7 weeks))
- Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score(Baseline, Post Treatment (5-7 weeks))
- Change in Lent Soma Scale Patient Questionnaire Score(Baseline, Post Treatment (5-7 weeks))
研究者
Mylin Torres, MD
Associate Professor
Emory University