Reducing Distress and Depressive-symptoms in Rural Women
Condition: Breast Cancer; Psychological Adjustment
MeSH terms: Breast Neoplasms; Depression
Study type: Interventional

Summary: 
      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;
      CaringGuidance™- 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 CaringGuidance™ program on distress and depressive-symptoms
      monthly and over 3 months, for rural women newly diagnosed with breast cancer.
    

Detailed description: 
      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;
      CaringGuidance™- 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 CaringGuidance™
      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 CaringGuidance™ 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 CaringGuidance™ 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.
    

Intervention name(s): CaringGuidance After Breast Cancer Diagnosis
Intervention type(s): Behavioral
Intervention description(s): CaringGuidance After Breast Cancer Diagnosis, psychoeducational, Internet-accessible program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care