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Clinical Trials/NCT05302375
NCT05302375
Recruiting
Not Applicable

Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)

Dartmouth-Hitchcock Medical Center1 site in 1 country30 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
30
Locations
1
Primary Endpoint
System usability
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to determine the extent to which an online pathway to depression treatment (iPath*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression.

Detailed Description

The investigators will determine the extent to which an online pathway to depression treatment (iPath\*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression. iPath\*D will be designed to increase screening, mental health literacy, and treatment access. Patients will access their iPath\*D account online to review their PHQ-9 score and its interpretation, followed by an interactive depression decision aid comparing information on a range of online and in-person treatment options. Upon review of the decision aid, participants will be able to directly connect to a treatment path via embedded hyperlinks in the decision aid. The investigators will determine the usability, acceptability, and feasibility of iPath\*D. The investigators will explore the hypothesis that iPath\*D will be highly usable, acceptable to patients, feasible to implement, and will result in improved mental health literacy, and greater treatment access. The tool for the study was developed during a preliminary portion (Aim 1) of the project, under D-H IRB number STUDY02001240 . This approach uses an open-label, single arm pilot, with adult patients receiving treatment for cancer in a rural cancer clinic, St Johnsbury, VT (Dartmouth Cancer Center North) (n=30) with moderate-severe depression, Aim 2 of the project.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
December 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul J. Barr

Associate Professor

Trustees of Dartmouth College

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

System usability

Time Frame: 2 weeks

System Usability Scale (10 items; mean ≥68/100),

Acceptability of intervention

Time Frame: 2 weeks

Acceptability of Intervention Measure (4 items), mean ≥4/5

Feasibility of intervention

Time Frame: 2 weeks

Feasibility of Intervention Measure (4 items), mean ≥4/5

Change in Mental Health Literacy (MHL)

Time Frame: Baseline, 2 weeks

A modified 10-item version for the validated multiple choice questionnaire (MCQ) for depression assesses treatment knowledge, understanding \& beliefs. Higher scores indicate higher MHL.

Change in number of patients selecting a treatment path to access

Time Frame: 2 weeks, 4 weeks, 6 weeks

Click on link to access online treatment service \| indicate in self-report survey accessing local resources

Secondary Outcomes

  • Change in treatment initiation (exploratory outcome)(2 weeks, 4 weeks, 6 weeks)
  • Decisional regret (exploratory outcome)(6 weeks)
  • Change in PHQ-9 completion (exploratory outcome)(Baseline, 2 weeks, 4 weeks, 6 weeks)
  • Change in treatment adherence (exploratory outcome)(2 weeks, 4 weeks, 6 weeks)
  • Change in quality of life (exploratory outcome)(Baseline, 6 weeks)
  • Change in PHQ-9 score (exploratory outcome)(Baseline, 2 weeks, 4 weeks, 6 weeks)

Study Sites (1)

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