Clinical trial NCT03465813: Reducing Distress and Depressive-symptoms in Rural Women
Official title: Reducing Distress and Depressive-symptoms in Rural Women Using CaringGuidance™-After Breast Cancer Diagnosis: Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Psychological Adjustment
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: University of Kansas Medical Center
First posted: 2018-03-14
Enrollment: 33
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change from baseline in distress at 1, 2, and 3 months
timeFrame: at baseline and months 1, 2, and 3
measure: change from baseline in depressive-symptoms at 1, 2, and 3 months
timeFrame: at baseline and months 1, 2, and 3
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Oncology Clinics
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Robin M Lally, PhD
role: PRINCIPAL_INVESTIGATOR
References: