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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05302375
Other study ID # STUDY02002016
Secondary ID R21CA249767
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date August 2024

Study information

Verified date May 2024
Source Dartmouth-Hitchcock Medical Center
Contact Susan Tarczewski
Phone 603-646-7066
Email susan.m.tarczewski@dartmouth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
iPath*D
Online pathway from screening to treatment for depression in cancer patients.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary System usability System Usability Scale (10 items; mean =68/100), 2 weeks
Primary Acceptability of intervention Acceptability of Intervention Measure (4 items), mean =4/5 2 weeks
Primary Feasibility of intervention Feasibility of Intervention Measure (4 items), mean =4/5 2 weeks
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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