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

NCT ID: NCT05302375

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-15

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.

Conditions

Cancer; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

iPath*D

An online platform that connects patients screening positive for clinically significant depression in cancer settings to a range of online and inperson evidence-based treatments, facilitated by an interactive DA.

Group Type: EXPERIMENTAL

iPath*D

Intervention Type: OTHER

Online pathway from screening to treatment for depression in cancer patients.

Interventions

iPath*D

Online pathway from screening to treatment for depression in cancer patients.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adults (≥18 years)

2. New patients who are beginning treatment at Dartmouth Cancer Center North and returning for their chemo teach or radiation simulation visit

3. Can communicate in English

4. PHQ-9 ≥10 and ≤27

Exclusion Criteria

1. Mild Depression (PHQ-9 ≥10)

2. Individuals who screen positive for suicidal ideation with method, intent, plan or a recent prior suicide/self-harm attempt, as determined by a positive endorsement of items 3, 4, 5 or 6 on the Columbia-Suicide Severity Rating Scale (C-SSR).

3. Individuals with bipolar disorder or psychosis (documented in the EMR)

4. Individuals currently receiving treatment for a mental health condition (documented in the EMR or self-reported during eligibility screening)

5. Significant cognitive impairment (Callahan's Six Item Screener of cognitive function ≤ 4; Self-reported during eligibility screening)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Paul J. Barr

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Barr, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Locations

Dartmouth Cancer Center St. Johnsbury

Saint Johnsbury, Vermont, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Susan Tarczewski

Role: CONTACT

susan.m.tarczewski@dartmouth.edu

603-646-7066

Paul Barr, Ph.D.

Role: CONTACT

paul.j.barr@dartmouth.edu

603-646-7016

Facility Contacts

Lora Schofield, RN, OCN, BSN

Role: primary

Lora.L.Schofield@hitchcock.org

802-473-4100

Other Identifiers

R21CA249767

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY02002016

Identifier Type: -

Identifier Source: org_study_id