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Reducing Distress and Depressive-symptoms in Rural Women

N/A
Waitlist Available
Led By Robin M Lally, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and months 1, 2, and 3
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Psychological Adjustment
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and months 1, 2, and 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and months 1, 2, and 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change from baseline in depressive-symptoms at 1, 2, and 3 months
change from baseline in distress at 1, 2, and 3 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CaringGuidance InterventionExperimental Treatment1 Intervention
Three months of web-based CaringGuidance psychoeducational program use, independently on home computer in addition to usual care.
Group II: Usual CareActive Control1 Intervention
Three months of care as usual from subjects' clinics and community as the subject chooses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CaringGuidance After Breast Cancer Diagnosis
2017
N/A
~40

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterOTHER
513 Previous Clinical Trials
176,982 Total Patients Enrolled
University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,353 Total Patients Enrolled
Robin M Lally, PhDPrincipal InvestigatorUniversity of Nebraska
~4 spots leftby Dec 2025
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