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

Depression Clinical Trial

— iPath Pilot  

Official title:

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

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
• 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
• 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)

Related Conditions & MeSH terms

• Cancer
• Depression
• Depressive Disorder

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