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

NCT ID: NCT05302375Sponsor: Dartmouth-Hitchcock Medical CenterLast updated: 2025-04-03

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.

Arms & interventions

  • OtheriPath*D

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

Outcome measures

Primary

  • System usability

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

    Time frame: 2 weeks

  • Acceptability of intervention

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

    Time frame: 2 weeks

  • Feasibility of intervention

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

    Time frame: 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

    Time frame: 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.

    Time frame: Baseline, 2 weeks

Secondary

  • Change in PHQ-9 completion (exploratory outcome)

    Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks

  • Change in treatment initiation (exploratory outcome)

    Time frame: 2 weeks, 4 weeks, 6 weeks

  • Change in treatment adherence (exploratory outcome)

    Time frame: 2 weeks, 4 weeks, 6 weeks

  • Decisional regret (exploratory outcome)

    Time frame: 6 weeks

  • Change in PHQ-9 score (exploratory outcome)

    Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks

  • Change in quality of life (exploratory outcome)

    Time frame: Baseline, 6 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Dartmouth Cancer Center St. Johnsbury

Saint Johnsbury, Vermont, 05819

Recruiting
Lora Schofield, RN, OCN, BSN · Contact
802-473-4100Lora.L.Schofield@hitchcock.org