Clinical trial · Interventional
Reducing Distress and Depressive-symptoms in Rural Women
Reducing Distress and Depressive-symptoms in Rural Women Using CaringGuidance™-After Breast Cancer Diagnosis: Randomized Controlled Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Psychological Adjustment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CaringGuidance After Breast Cancer Diagnosis | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CaringGuidance Intervention
- description
- Three months of web-based CaringGuidance psychoeducational program use, independently on home computer in addition to usual care.
- interventionNames
- Behavioral: CaringGuidance After Breast Cancer Diagnosis
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Three months of care as usual from subjects' clinics and community as the subject chooses.
Primary outcomes (2)
- measure
- change from baseline in distress at 1, 2, and 3 months
- timeFrame
- at baseline and months 1, 2, and 3
- description
- self-report of psychological distress
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available