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Clinical Trials/NCT07091968
NCT07091968Active, not recruitingNot Applicable

Pilot Feasibility Trial to Evaluate a Technology-Enabled Approach to Enhance Depression Referral Uptake Among Cancer Survivors

Medical University of South Carolina1 site in 1 country60 target enrollmentStarted: January 16, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
60
Locations
1
Primary Endpoint
Feasibility and Acceptability

Study Overview

Brief Summary

Depression is very common in cancer survivors but there are challenges to linking those in need of treatment efficiently to care. In this study, investigators will test the feasibility and acceptability of a new text-based approach to connect cancer survivors with depression with care.

Detailed Description

The objectives of this study are 1) to evaluate the feasibility and acceptability of a technology-enabled approach to improve referral uptake among cancer survivors and 2) to evaluate the preliminary efficacy of this approach to improve referral uptake compared to usual care among cancer survivors.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.
  • •elevated depressive symptoms at screening (as measured by > 3 on the PHQ-2)

Exclusion Criteria

  • •cognitive impairment as evaluated by attending physician
  • •currently receiving counseling for depression

Arms & Interventions

Technology-Enabled Tailored Referral

Experimental

Participants in the intervention arm will receive a technology-enabled, text-based referral platform designed to improve depression referral uptake. The platform includes an initial text with a brief video explaining common barriers, tailored text messages based on participant-identified barriers, and an automated referral link. Messages are mapped to stages of readiness using the Transtheoretical Model and sent every two days over a two-week period to non-responders or decliners. This approach aims to engage survivors with depression care through personalized, accessible, and stage-matched communication.

Intervention: Technology-Enabled Tailored Referral (Behavioral)

Usual Care Referral

No Intervention

Participants in the usual care arm will receive a printed flyer with information on local and virtual mental health treatment resources. The flyer includes contact details for emergency services, psychiatric urgent care, psychological oncology programs, support groups, and behavioral health clinics in the Charleston area, many of which offer telehealth options. No personalized messages or follow-up outreach will be provided.

Outcomes

Primary Outcomes

Feasibility and Acceptability

Time Frame: 6 weeks

The co-primary outcomes are acceptability and feasibility of the technology-enabled referral intervention. Acceptability will be measured using the System Usability Scale (SUS) at 6 weeks, with a score ≥80 indicating high acceptability. Feasibility will be assessed by determining whether key components of the intervention were successfully delivered and engaged with over the course of the 4 week intervention, including: (1) initiation of text-based contact, (2) delivery of tailored messages, and (3) access of the automated referral link by the participant. Additionally, participant engagement will be evaluated by tracking whether they opened the initial message, viewed the embedded video, and read the tailored text messages. These outcomes will be summarized using a Bayesian beta-binomial approach to determine go/no-go decision thresholds for future scale-up.

Secondary Outcomes

  • Referral Uptake(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Katherine Sterba

Professor-Faculty

Medical University of South Carolina

Study Sites (1)

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