CancerNCT07091968
Feasibility of a Technology-Based Intervention for Depression Referral Uptake in Cancer Survivors
A study testing Technology-Enabled Tailored Referral in people with Cancer and Depression, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Depression
- What is being tested?
- Technology-Enabled Tailored Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- cognitive impairment as evaluated by attending physician
- currently receiving counseling for depression
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Pilot Feasibility Trial to Evaluate a Technology-Enabled Approach to Enhance Depression Referral Uptake Among Cancer Survivors
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.
Read the 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.
- Conditions
- Cancer, Depression
- Being tested
- Technology-Enabled Tailored Referral
- Medical subject headings
- Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-Enabled Tailored ReferralBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
Referral Uptake
Referral uptake is defined as whether a participant initiates a mental health treatment referral at 6 weeks. It will be measured through participant self-report and, when available, verified via electronic health records or provider confirmation.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start16 Jan 2026
- Primary completion26 Aug 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Sterba, Medical University of South Carolina
- Investigators
- Katherine Sterba, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091968
- Sponsor's protocol ID
- Pro00142801
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will not be shared with individual participants; data will be used for internal analysis and publication.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Trial to Evaluate a Technology-Enabled Approach to Enhance Depression Referral Uptake Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT07091968
- Acronym / sponsor ID
- Pro00142801
- Conditions
- Cancer, Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 26 Aug 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-Enabled Tailored Referral | Experimental | Behavioral: Technology-Enabled Tailored ReferralParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- cognitive impairment as evaluated by attending physician
- currently receiving counseling for depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-Enabled Tailored ReferralParticipants 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. | Behavioural | Technology-Enabled Tailored Referral |
Primary outcome
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.
1 secondary outcome
Referral Uptake
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. Results will not be shared with individual participants; data will be used for internal analysis and publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Sterba, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-Enabled Tailored Referral in people with Cancer and Depression, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.