Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D
Primary Purpose
Cancer, Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iPath*D
Sponsored by

About this trial
This is an interventional other trial for Cancer focused on measuring shared decision making, decision aid, depression
Eligibility Criteria
Inclusion criteria
- Adults (≥18 years)
- New patients who are beginning treatment at NCCC North and returning for their chemo teach or radiation simulation visit
- Can communicate in English
- 10≤ PHQ-9 ≤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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iPath*D
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Mental Health Literacy
The validated 27-item multiple choice questionnaire (MCQ) for depression assesses treatment knowledge, understanding & beliefs. Scores range from 0 - 27, with higher scores indicating higher MHL.
System usability
System Usability Scale (10 items; mean ≥68/100),
Acceptability of intervention
Acceptability of Intervention Measure (4 items), mean ≥4/5
Feasibility of intervention
Feasibility of Intervention Measure (4 items), mean ≥4/5
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
Secondary Outcome Measures
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.
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
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
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)
Change in PHQ-9 score (exploratory outcome)
Response; 5-point reduction in baseline PHQ-9 score. Remission; PHQ-9 score of <5 points
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)
Full Information
NCT ID
NCT05302375
First Posted
March 21, 2022
Last Updated
July 31, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05302375
Brief Title
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D
Official Title
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Depression
Keywords
shared decision making, decision aid, depression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iPath*D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
iPath*D
Intervention Description
Online pathway from screening to treatment for depression in cancer patients.
Primary Outcome Measure Information:
Title
Change in Mental Health Literacy
Description
The validated 27-item multiple choice questionnaire (MCQ) for depression assesses treatment knowledge, understanding & beliefs. Scores range from 0 - 27, with higher scores indicating higher MHL.
Time Frame
Baseline, 2 weeks
Title
System usability
Description
System Usability Scale (10 items; mean ≥68/100),
Time Frame
2 weeks
Title
Acceptability of intervention
Description
Acceptability of Intervention Measure (4 items), mean ≥4/5
Time Frame
2 weeks
Title
Feasibility of intervention
Description
Feasibility of Intervention Measure (4 items), mean ≥4/5
Time Frame
2 weeks
Title
Change in number of patients selecting a treatment path to access
Description
Click on link to access online treatment service | indicate in self-report survey accessing local resources
Time Frame
2 weeks, 4 weeks, 6 weeks
Secondary Outcome Measure Information:
Title
Change in PHQ-9 completion (exploratory outcome)
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks
Title
Change in treatment initiation (exploratory outcome)
Description
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
Time Frame
2 weeks, 4 weeks, 6 weeks
Title
Change in treatment adherence (exploratory outcome)
Description
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
Time Frame
2 weeks, 4 weeks, 6 weeks
Title
Decisional regret (exploratory outcome)
Description
The Decisional Regret Scale assesses satisfaction with a healthcare decision (5-items, scores range from 0-100, with higher scores indicating high regret)
Time Frame
6 weeks
Title
Change in PHQ-9 score (exploratory outcome)
Description
Response; 5-point reduction in baseline PHQ-9 score. Remission; PHQ-9 score of <5 points
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks
Title
Change in quality of life (exploratory outcome)
Description
Functional Assessment of Cancer Therapy-General (FACT-G) scale (27-items, scores range from 0-108 with higher scores indicating higher quality of life)
Time Frame
Baseline, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Tarczewski
Phone
603-646-7066
Email
susan.m.tarczewski@dartmouth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Barr, Ph.D.
Phone
603-646-7016
Email
paul.j.barr@dartmouth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Barr, Ph.D.
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
At the conclusion of this study, the investigators plan to make available, upon request, a public use file of all participant-level study data. Investigators will use appropriate de-identification and security measures. Plain-language descriptions of data sharing plans will be included in informed consents.
Dartmouth College will retain ownership and all rights to all intellectual property and will provide public access to data. Appropriate documentation will also be provided regarding information about the methodology and procedures used to collect the data, details about codes and definitions of variables.
IPD Sharing Time Frame
At the time of publication or at the end of the grant period, whichever comes first.
IPD Sharing Access Criteria
De-identified data will be available upon request from the PI to qualified investigators, with appropriate IRB approval, and for research purposes only.
Learn more about this trial
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D
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