Cancer, Depression
Conditions
Keywords
shared decision making, decision aid, depression
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, 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.
Interventions
OTHERiPath*D
Online pathway from screening to treatment for depression in cancer patients.
Sponsors
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System usability | 2 weeks | System Usability Scale (10 items; mean ≥68/100), |
| Acceptability of intervention | 2 weeks | Acceptability of Intervention Measure (4 items), mean ≥4/5 |
| Feasibility of intervention | 2 weeks | Feasibility of Intervention Measure (4 items), mean ≥4/5 |
| Change in number of patients selecting a treatment path to access | 2 weeks, 4 weeks, 6 weeks | Click on link to access online treatment service \| indicate in self-report survey accessing local resources |
| Change in Mental Health Literacy (MHL) | Baseline, 2 weeks | A modified 10-item version for the validated multiple choice questionnaire (MCQ) for depression assesses treatment knowledge, understanding \& beliefs. Higher scores indicate higher MHL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PHQ-9 completion (exploratory outcome) | Baseline, 2 weeks, 4 weeks, 6 weeks | 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) | 2 weeks, 4 weeks, 6 weeks | 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) | 2 weeks, 4 weeks, 6 weeks | 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) | 6 weeks | 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) | Baseline, 2 weeks, 4 weeks, 6 weeks | Response; 5-point reduction in baseline PHQ-9 score. Remission; PHQ-9 score of \<5 points |
| Change in quality of life (exploratory outcome) | Baseline, 6 weeks | Functional Assessment of Cancer Therapy-General (FACT-G) scale (27-items, scores range from 0-108 with higher scores indicating higher quality of life) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPaul Barr, Ph.D.
Dartmouth College
Outcome results
None listed