NCT06894849

Brief Summary

Depression is common among cancer survivors, but current screening methods are not always effective. To help improve depression screening for cancer survivors, this study will conduct a pilot randomized controlled trial (RCT) with 60 participants. The goal is to evaluate whether a text message-based approach to depression screening is feasible, acceptable, and potentially more effective than the current standard of 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
2mo left

Started Jan 2026

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

February 6, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

February 6, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

Cancer SurvivorshipDepression ScreeningText Message ScreeningMobile Health

Outcome Measures

Primary Outcomes (1)

  • Study Feasibility

    \>/= 1 response to a text message

    2 weeks after randomization

Secondary Outcomes (4)

  • Acceptability

    2 weeks

  • Depression screening

    2 weeks

  • PHQ-2 score

    2 weeks

  • PHQ-9 score

    2 weeks

Study Arms (2)

Text-Based Depression Screening

EXPERIMENTAL
Behavioral: Text-based depression screening

Usual Care

ACTIVE COMPARATOR
Behavioral: Usual care (UC)

Interventions

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).

Text-Based Depression Screening
Usual care (UC)BEHAVIORAL

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.

Usual Care

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

ENROLLING BY INVITATION

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Evan Graboyes, MD, MPH, FACS

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruby H McGhee, B.A. Psychology

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor-Faculty

Study Record Dates

First Submitted

February 6, 2025

First Posted

March 25, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations