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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
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer focused on measuring shared decision making, decision aid, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  1. Adults (≥18 years)
  2. New patients who are beginning treatment at NCCC North and returning for their chemo teach or radiation simulation visit
  3. Can communicate in English
  4. 10≤ PHQ-9 ≤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)

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

    First Posted
    March 21, 2022
    Last Updated
    July 31, 2023
    Sponsor
    Dartmouth-Hitchcock Medical Center
    Collaborators
    National Cancer Institute (NCI)
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    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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