NCT07091968

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
7mo left

Started Jan 2026

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

July 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 16, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 3, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

July 21, 2025

Last Update Submit

January 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility and Acceptability

    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.

    6 weeks

Secondary Outcomes (1)

  • Referral Uptake

    6 weeks

Study Arms (2)

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.

Behavioral: Technology-Enabled Tailored Referral

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.

Interventions

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 through personalized, accessible, and stage-matched communication.

Technology-Enabled Tailored Referral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

NeoplasmsDepression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Katherine Sterba, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lily P Research Assistant/Coordinator, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor-Faculty

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 29, 2025

Study Start

January 16, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 3, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Results will not be shared with individual participants; data will be used for internal analysis and publication.

Locations