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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA249767 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iPath*D | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iPath*D | Other | Online pathway from screening to treatment for depression in cancer patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| System usability | System Usability Scale (10 items; mean ≥68/100), | 2 weeks |
| Acceptability of intervention | Acceptability of Intervention Measure (4 items), mean ≥4/5 | 2 weeks |
| Feasibility of intervention | Feasibility of Intervention Measure (4 items), mean ≥4/5 | 2 weeks |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan Tarczewski | Contact | 603-646-7066 | susan.m.tarczewski@dartmouth.edu | |
| Paul Barr, Ph.D. | Contact | 603-646-7016 | paul.j.barr@dartmouth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul Barr, Ph.D. | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Cancer Center St. Johnsbury | Recruiting | Saint Johnsbury | Vermont | 05819 | United States |
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.
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At the time of publication or at the end of the grant period, whichever comes first.
De-identified data will be available upon request from the PI to qualified investigators, with appropriate IRB approval, and for research purposes only.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Baseline, 2 weeks, 4 weeks, 6 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |