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| Name | Class |
|---|---|
| University of Kansas Medical Center | OTHER |
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Approximately 30% of U.S. breast cancer survivors experience significant cancer-related distress ranging from adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. For rural cancer survivors, lack of access to care, support and stigma associated with cancer and mental health, challenge rural women's ability to prevent cancer-related distress and its deleterious outcomes. However, these barriers may be overcome by a new Internet-based psychoeducational program designed for newly diagnosed women; CaringGuidanceâ„¢- After Breast Cancer Diagnosis. This self-guided program provides information, cognitive-behavioral and supportive coping strategies in a text/audio/visual format accessed via Internet/mobile devices to increase understanding and provide supportive tools to prevent/manage distress and depressive-symptoms. This pilot study will determine preliminary efficacy of the CaringGuidanceâ„¢ program on distress and depressive-symptoms monthly and over 3 months, for rural women newly diagnosed with breast cancer.
Of the 3.1 million U.S. breast cancer survivors, approximately 30% experience significant cancer-related distress ranging from sub-threshold to diagnosable adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. Rural cancer survivors report poorer mental health than urban survivors. Lack of access to care, support and stigma associated with cancer and mental health, challenge rural women's ability to prevent cancer-related distress and its deleterious outcomes. These barriers may be overcome by a new Internet-based, psychoeducational program designed for newly diagnosed women; CaringGuidanceâ„¢- After Breast Cancer Diagnosis. This self-guided program provides information, cognitive-behavioral and supportive coping strategies in a text/audio/visual format accessed via Internet/mobile devices to increase understanding, and provide supportive tools to prevent/manage distress and depressive-symptoms.
The aims of this pilot study are to determine preliminary efficacy of the CaringGuidanceâ„¢ program on distress and depressive-symptoms monthly and over 3 months, for rural women newly diagnosed with breast cancer, and trial measures and methods, prior to a fully powered randomized controlled clinical trial.
Sixty rural women, will be randomized to 3 months of self-guided CaringGuidanceâ„¢ program access with usual care or usual care alone. Both groups complete monthly standard psychosocial measures, daily activity/symptom logs and receive a monthly call. Program engagement/dose will be measured by the CaringGuidanceâ„¢ internal data system. Descriptive and inferential statistics will characterize the sample and determine differences between groups at monthly intervals and overall. Variability of outcome variables will also be assessed to determine usefulness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CaringGuidance Intervention | Experimental | Three months of web-based CaringGuidance psychoeducational program use, independently on home computer in addition to usual care. |
|
| Usual Care | No Intervention | Three months of care as usual from subjects' clinics and community as the subject chooses. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CaringGuidance After Breast Cancer Diagnosis | Behavioral | CaringGuidance After Breast Cancer Diagnosis, psychoeducational, Internet-accessible program |
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| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in distress at 1, 2, and 3 months | self-report of psychological distress | at baseline and months 1, 2, and 3 |
| change from baseline in depressive-symptoms at 1, 2, and 3 months | self-report of depressive-symptoms | at baseline and months 1, 2, and 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin M Lally, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center, Oncology Clinics | Omaha | Nebraska | 68131 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |