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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer, Depression

Intervention / Treatment
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* Other: iPath*D


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 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 Exclusion criteria 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iPath*D<br>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<br>* Online pathway from screening to treatment for depression in cancer patients.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shared decision making, decision aid, depression