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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Cancer
• Intervention / Treatment: Other: iPath*D

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Tarczewski; Phone Number: 603-646-7066; Email: susan.m.tarczewski@dartmouth.edu
• Study Contact Backup: Name: Paul Barr, Ph.D.; Phone Number: 603-646-7016; Email: paul.j.barr@dartmouth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: iPath*D; Online pathway from screening to treatment for depression in cancer patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PHQ-9 completion (exploratory outcome)	Number of patients who complete Patient Health Questionnaire (PHQ-9), a validated nine item depression scale. A score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.	Baseline, 2 weeks, 4 weeks, 6 weeks
Change in treatment initiation (exploratory outcome)	Proportion of patients who self-report treatment initiation e.g., fill antidepressant prescription, visited with psychiatrist for talk therapy, began a cCBT program, or other service	2 weeks, 4 weeks, 6 weeks
Change in treatment adherence (exploratory outcome)	Proportion of patients who self-report continued adherence to treatment e.g., antidepressant refill (yes/no), number of talk therapy sessions completed, or Computerised Cognitive Behavioural Therapy (cCBT) modules completed	2 weeks, 4 weeks, 6 weeks
Decisional regret (exploratory outcome)	The Decisional Regret Scale assesses satisfaction with a healthcare decision (5-items, scores range from 0-100, with higher scores indicating high regret)	6 weeks
Change in PHQ-9 score (exploratory outcome)	Response; 5-point reduction in baseline PHQ-9 score. Remission; PHQ-9 score of <5 points	Baseline, 2 weeks, 4 weeks, 6 weeks
Change in quality of life (exploratory outcome)	Functional Assessment of Cancer Therapy-General (FACT-G) scale (27-items, scores range from 0-108 with higher scores indicating higher quality of life)	Baseline, 6 weeks

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Paul Barr, Ph.D., Dartmouth College

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: depression; shared decision making; decision aid
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: STUDY02002016; R21CA249767 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

At the conclusion of this study, the investigators plan to make available, upon request, a public use file of all participant-level study data. Investigators will use appropriate de-identification and security measures. Plain-language descriptions of data sharing plans will be included in informed consents.

Dartmouth College will retain ownership and all rights to all intellectual property and will provide public access to data. Appropriate documentation will also be provided regarding information about the methodology and procedures used to collect the data, details about codes and definitions of variables.

• IPD Sharing Time Frame: At the time of publication or at the end of the grant period, whichever comes first.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No