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NCT Number: NCT05302375

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

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.

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Key information

Conditions

Cancer Behavior Behavioral Symptoms Depression Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Cancer Center St. Johnsbury

Saint Johnsbury, Vermont, 05819, United States

Location status: Recruiting

Location contact

Lora Schofield, RN, OCN, BSN

CONTACT

[email protected]

802-473-4100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

iPath*D

Other

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

Primary outcomes

  1. System usability

    Time frame: 2 weeks

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

  2. Acceptability of intervention

    Time frame: 2 weeks

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

  3. Feasibility of intervention

    Time frame: 2 weeks

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

  4. Change in number of patients selecting a treatment path to access

    Time frame: 2 weeks, 4 weeks, 6 weeks

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

  5. Change in Mental Health Literacy (MHL)

    Time frame: Baseline, 2 weeks

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

Secondary outcomes

  1. Change in PHQ-9 completion (exploratory outcome)

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

    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.

  2. Change in treatment initiation (exploratory outcome)

    Time frame: 2 weeks, 4 weeks, 6 weeks

    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

  3. Change in treatment adherence (exploratory outcome)

    Time frame: 2 weeks, 4 weeks, 6 weeks

    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

  4. Decisional regret (exploratory outcome)

    Time frame: 6 weeks

    The Decisional Regret Scale assesses satisfaction with a healthcare decision (5-items, scores range from 0-100, with higher scores indicating high regret)

  5. Change in PHQ-9 score (exploratory outcome)

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

    Response; 5-point reduction in baseline PHQ-9 score. Remission; PHQ-9 score of <5 points

  6. Change in quality of life (exploratory outcome)

    Time frame: Baseline, 6 weeks

    Functional Assessment of Cancer Therapy-General (FACT-G) scale (27-items, scores range from 0-108 with higher scores indicating higher quality of life)

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Barr, Ph.D.

CONTACT

[email protected]

603-646-7016

Susan Tarczewski

CONTACT

[email protected]

603-646-7066

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: iPath Pilot

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2022
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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