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

NCT05302375 | Recruiting

• 2 other identifiers: STUDY02002016R21CA249767
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Depression

Keywords

shared decision making; decision aid; depression

Outcome Measures

Primary Outcomes (5)

• System usability

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

  2 weeks

• Acceptability of intervention

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

  2 weeks

• Feasibility of intervention

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

  2 weeks

• Change in number of patients selecting a treatment path to access

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

  2 weeks, 4 weeks, 6 weeks

• Change in Mental Health Literacy (MHL)

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

  Baseline, 2 weeks

Secondary Outcomes (6)

• Change in PHQ-9 completion (exploratory outcome)

  Baseline, 2 weeks, 4 weeks, 6 weeks

• Change in treatment initiation (exploratory outcome)

  2 weeks, 4 weeks, 6 weeks

• Change in treatment adherence (exploratory outcome)

  2 weeks, 4 weeks, 6 weeks

• Decisional regret (exploratory outcome)

  6 weeks

• Change in PHQ-9 score (exploratory outcome)

  Baseline, 2 weeks, 4 weeks, 6 weeks

Study Arms (1)

iPath*D

EXPERIMENTAL

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.

Other: iPath*D

Interventions

iPath*D OTHER

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

iPath*D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years)
• New patients who are beginning treatment at Dartmouth Cancer Center North and returning for their chemo teach or radiation simulation visit
• Can communicate in English
• PHQ-9 ≥10 and ≤27

You may not qualify if:

• Mild Depression (PHQ-9 ≥10)
• 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).
• Individuals with bipolar disorder or psychosis (documented in the EMR)
• Individuals currently receiving treatment for a mental health condition (documented in the EMR or self-reported during eligibility screening)
• Significant cognitive impairment (Callahan's Six Item Screener of cognitive function ≤ 4; Self-reported during eligibility screening)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dartmouth Cancer Center St. Johnsbury

Saint Johnsbury, Vermont, 05819, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Paul Barr, Ph.D.

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Tarczewski

CONTACT

603-646-7066; susan.m.tarczewski@dartmouth.edu

Paul Barr, Ph.D.

CONTACT

603-646-7016; paul.j.barr@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 15, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the time of publication or at the end of the grant period, whichever comes first.
• Access Criteria: De-identified data will be available upon request from the PI to qualified investigators, with appropriate IRB approval, and for research purposes only.

Locations

US (1)