Reducing Distress and Depressive-symptoms in Rural Women
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Depression |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 19 - 85 |
| Updated: | 7/22/2018 |
| Start Date: | July 19, 2017 |
| End Date: | July 1, 2019 |
| Contact: | Robin M Lally, PhD |
| Email: | robin.lally@unmc.edu |
| Phone: | 402-559-5464 |
Reducing Distress and Depressive-symptoms in Rural Women Using CaringGuidance™-After Breast Cancer Diagnosis: Randomized Controlled Pilot Study
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 RCT.
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.
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 RCT.
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.
Inclusion Criteria:
- experiencing their first, stage 0 - IIIA breast cancer diagnosis (either clinical or
definitive early stage at enrollment), and be 19 to 85 years of age,
- enroll < 3 months post-diagnosis (as soon as possible after diagnosis is desirable),
- reside in a non-metro county of the United States according to the USDA Rural-Urban
Continuum Codes (6 -9) (RUCC) or at a rural zip-code by the USDA Rural Urban Commuting
Area (RUCA) codes (4.0, 4.2, 5.0, 5.2, 6.0, 6.1, 7.0, 7.2-4, 8.0, 8.2-4, 9.0-2, 10.0,
10.2-6)
- be able to read and write in English since the CaringGuidance™ program is in English,
- have regular access (e.g. home or work) to high speed/satellite broadband Internet on
desk/laptop or wireless iPad, Android or iPhone throughout the 3 months of the study,*
- have an email address at which to receive CaringGuidance™ prompts,
- have a Baseline Distress Thermometer score of > 4, or an Impact of Events Scale score
of > 9, or Center for Epidemiological Studies Depression Scale score of > 16 (i.e.
clinically meaningful thresholds).
- Able to comprehend and provide informed consent
Exclusion Criteria:
- Men and women with recurrent or advanced breast cancer
- Those mentally or physically unable to read the consent form or other study materials
and/or participate in the consent and engagement with the CaringGuidance program.
Women who have been hospitalized for mental health issues or substance abuse in the
past year are ineligible.
We found this trial at
1
site
620 South 42nd Street
Omaha, Nebraska 68131
Omaha, Nebraska 68131
Phone: 402-559-5464
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