NCT03465813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

February 28, 2018

Last Update Submit

September 21, 2023

Conditions

Breast CancerPsychological Adjustment

Outcome Measures

Primary Outcomes (2)

  • change from baseline in distress at 1, 2, and 3 months

    self-report of psychological distress

    at baseline and months 1, 2, and 3

  • change from baseline in depressive-symptoms at 1, 2, and 3 months

    self-report of depressive-symptoms

    at baseline and months 1, 2, and 3

Study Arms (2)

CaringGuidance Intervention

EXPERIMENTAL

Three months of web-based CaringGuidance psychoeducational program use, independently on home computer in addition to usual care.

Behavioral: CaringGuidance After Breast Cancer Diagnosis

Usual Care

NO INTERVENTION

Three months of care as usual from subjects' clinics and community as the subject chooses.

Interventions

CaringGuidance After Breast Cancer DiagnosisBEHAVIORAL

CaringGuidance After Breast Cancer Diagnosis, psychoeducational, Internet-accessible program

CaringGuidance Intervention

Eligibility Criteria

Age19 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, Oncology Clinics

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robin M Lally, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 14, 2018

Study Start

July 19, 2017

Primary Completion

May 11, 2019

Study Completion

May 30, 2019

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)