Ignite Creation Date:
2024-05-06 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03465813
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2018-02-28
Brief Title:
Reducing Distress and Depressive-symptoms in Rural Women
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Reducing Distress and Depressive-symptoms in Rural Women Using CaringGuidance-After Breast Cancer Diagnosis Randomized Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Approximately 30 of US 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 womens 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 textaudiovisual format accessed via Internetmobile devices to increase understanding and provide supportive tools to preventmanage 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 31 million US 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 womens 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 textaudiovisual format accessed via Internetmobile devices to increase understanding and provide supportive tools to preventmanage 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 activitysymptom logs and receive a monthly call Program engagementdose 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
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 activitysymptom logs and receive a monthly call Program engagementdose 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None