- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06894849
Text -Based Depression Screening Among Cancer Survivors (OASIS1)
Evaluation of a Text Message-Based Approach to Depression Screening Among Cancer Survivors
Study Overview
Status
Intervention / Treatment
Detailed Description
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary efficacy of a text message-based depression screening approach for cancer survivors. A total of 60 adult cancer survivors will be enrolled and randomly assigned to either the text message intervention or the usual care depression screening. The intervention involves sending text messages one week before scheduled oncology appointments, inviting participants to complete a depression screening using the PHQ-2, followed by the PHQ-9 for those who screen positive.
The study will assess the feasibility of implementing text message-based screenings, participant acceptability, and compare the efficacy of this method to traditional in-person depression screenings during clinical visits. The primary outcome is feasibility, measured by the proportion of participants completing the screening via text, while secondary outcomes will include acceptability (assessed through participant surveys) and preliminary efficacy (measured by screening completion rates and depression detection).
Eligible participants will be English-speaking cancer survivors aged 18 or older with an upcoming oncology appointment at the Hollings Cancer Center or associated clinics. The study aims to improve current depression screening methods and address challenges such as logistical and system-level barriers in screening cancer survivors for depression.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age > 18 years
- diagnosis of cancer
- upcoming appointment in an HCC or HCN oncology clinic within 14 days
- English proficiency
- ownership of a cellphone with SMS text capability.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual Care
|
Usual care (UC) will consist of in-person assessment of depression using a validated brief screening tool (e.g., PHQ-2) synchronous with a clinical encounter with the outpatient oncology team.
Although the person completing the screening (e.g., nurse, medical assistant) and other workflow may vary slightly across settings, the 2-items are generally presented orally to the patient during routine intake for a clinical encounter and entered into the EHR.
Patients who screen positive will be asked to complete the full PHQ-9.
|
|
Experimental: Text-Based Depression Screening
|
Starting 1 week prior to the scheduled clinic appointment, patients will receive a text message invitation from HCC to complete depression screening.
Participants will be asked to click to continue to the screening PHQ-2.
For text message screening cadence, reminder texts will be sent daily for 3 days.
Those who screen positive (PHQ-2 >/= 3) will complete the remainder of the items (i.e., PHQ-9).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Study Feasibility
Time Frame: 2 weeks after randomization
|
>/= 1 response to a text message
|
2 weeks after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: 2 weeks
|
acceptability will be rated on a likert scale form 0-5 with higher scores representing greater acceptability
|
2 weeks
|
|
Depression screening
Time Frame: 2 weeks
|
completion of PHQ-2 (Y/N)
|
2 weeks
|
|
PHQ-2 score
Time Frame: 2 weeks
|
The PHQ-2 is a validated 2-item measure of depression screening that is widely used among patients with cancer.
The PHQ-2 score ranges from 0 to 6. Higher scores indicate more severe depressive symptoms; a PHQ-2 score of ≥ 3 is considered a positive screening.
|
2 weeks
|
|
PHQ-9 score
Time Frame: 2 weeks
|
Participants who screen positive for elevated depressive symptoms on the PHQ-2 (i.e, > 3) will complete the PHQ-9, a validated 9-item measure of depression.
The PHQ-9 has high sensitivity and specificity for identifying individuals with depressive symptoms, particularly among cancer survivors.
The PHQ-9 score ranges from 0 to 27; higher scores represent more severe depressive symptoms.
A PHQ-9 score of ≥ 8 indicates clinically significant elevated depressive symptoms among patients with cancer.
|
2 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Evan Graboyes, MD, MPH, FACS, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00142039
- FD006/CC001335/FN09 (Other Grant/Funding Number: Hollings Cancer Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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