Clinical trial NCT05302375: Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Official title: Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Depression
Keywords: shared decision making
decision aid
depression
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: System usability
timeFrame: 2 weeks
measure: Acceptability of intervention
timeFrame: 2 weeks
measure: Feasibility of intervention
timeFrame: 2 weeks
measure: Change in number of patients selecting a treatment path to access
timeFrame: 2 weeks, 4 weeks, 6 weeks
measure: Change in Mental Health Literacy (MHL)
timeFrame: Baseline, 2 weeks
Secondary outcomes:
measure: Change in PHQ-9 completion (exploratory outcome)
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks
measure: Change in treatment initiation (exploratory outcome)
timeFrame: 2 weeks, 4 weeks, 6 weeks
measure: Change in treatment adherence (exploratory outcome)
timeFrame: 2 weeks, 4 weeks, 6 weeks
measure: Decisional regret (exploratory outcome)
timeFrame: 6 weeks
measure: Change in PHQ-9 score (exploratory outcome)
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks
measure: Change in quality of life (exploratory outcome)
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Saint Johnsbury
country: United States
facility: Dartmouth Cancer Center St. Johnsbury
state: Vermont
Study officials:
affiliation: Dartmouth College
name: Paul Barr, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: