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CancerNCT06930729

Optimizing Care for Cancer Survivors With Depression: Project 3

A study testing Behavioral Activation Therapy App and Telehealth Delivered Behavioral Activation in people with Cancer and Depression, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to evaluate different depression treatment approaches among cancer survivors. A cancer survivor is defined as anyone who is living and has been diagnosed with cancer. 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?
Behavioral Activation Therapy App and Telehealth Delivered Behavioral Activation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
12 Aug 2025to 22 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

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+
  • cancer survivor
  • current elevated depressive symptoms defined per ASCO as a PHQ-9 score ≥ 8
  • not currently receiving psychosocial depression treatment
  • have the ability to complete treatment via telehealth and use Moodivate
  • have a valid e-mail address or text message access (for assessments)
  • English fluency

Who cannot join

  • Current suicidal ideation at final eligibility screening (PHQ-9 item 9 ≥1)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Optimizing Care for Cancer Survivors With Depression (OASIS): Project 3

The purpose of this research study is to evaluate different depression treatment approaches among cancer survivors. A cancer survivor is defined as anyone who is living and has been diagnosed with cancer.

Participants will be randomly assigned to either receive a mobile app for depression treatment, called "Moodivate", or to receive telehealth depression treatment sessions. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will receive depression treatment via telehealth. Participants that receive Moodivate may later be assigned to also receive depression treatment via telehealth based their response to the Moodivate app. Participants will be asked to either use the Moodivate app and/or receive depression treatment via telehealth for a period of 10 weeks.

Read more

All participants will be asked to electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as general experiences using Moodivate and participating in this trial. Participation in this study will take about 24 weeks.

Participation in this study may help improve options for emotional wellness for cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality.

Read the detailed description

Depression is Highly Prevalent Among Cancer Survivors and Novel Care Delivery Approaches are Needed. Nearly one in four cancer survivors suffer from depression, with negative sequalae including lower quality of life, reduced adherence to cancer treatments, suicidal ideation, and desire for hastened death. Guidelines from leading oncology and mental health organizations including the American Society of Clinical Oncology (ASCO), the National Comprehensive Cancer Network, and the Commission on Cancer, recommend empirically based psychosocial interventions, such as Behavioral Activation (BA), as first line therapies. Unfortunately, despite guidelines, multilevel barriers, including transportation issues, stigma, and a scarcity of oncology mental health providers, limit widespread access to psychosocial first line depression therapies via usual care delivery approaches. These barriers are highly prominent in South Carolina (SC), the state at the focus of this Team Science Award. All SC counties contain medically underserved areas, and 15% of South Carolinians reside in rural areas. Novel care delivery approaches that address these multilevel barriers and extend psychosocial treatment access for cancer survivors in SC and beyond are clearly needed.

Self-guided digital mental health interventions (DMHIs) are an alternative psychosocial treatment delivery approach uniquely suited to addressing multilevel treatment barriers. Such interventions are delivered via technology-based platforms such as mobile apps, offer adaptations of evidence-based interventions, decrease the need for trained providers, and have a large evidence base in the general population as well as among cancer survivors indicating feasibility, acceptability, and comparable effects to standard psychosocial interventions when used as directed. Self-guided DMHIs are particularly well suited to the needs of cancer survivors because their flexible, self-directed pace can accommodate fluctuations in physical and mental health symptoms experienced due to cancer progression, side-effects, and/or cancer treatment transitions.

The extant literature on digital stepped care approaches has been similarly limited in terms of when and how decisions to step up care are made. Despite mounting evidence highlighting between-patient variability in DMHI engagement and clear, logical connection between engagement and clinical response, extant digitally-enhanced stepped care approaches have relied on clinical symptom change as the deciding factor for stepping. Whereas symptom change must be assessed over the course of months, intervention engagement can be assessed soon after starting treatment. By using passively collected DMHI analytics data, patients who do not engage with the DMHI can be stepped up, reducing delays in receipt of appropriate treatment. Evaluation of a stepped-care model, whereby cancer survivors with depressive symptoms first receive a low resource-intensive, yet still evidence-based, self-guided DMHI and then, if they do not engage within the first two weeks, are stepped up to the more resource-intensive gold standard psychosocial intervention, could help realize precision population health goals of providing the most effective and least resource-intensive intervention to all patients.

The current study will evaluate a digitally-enhanced stepped depression treatment approach for cancer survivors. This trial will lay the groundwork for a P01 project that will determine whether a digitally-enhanced stepped depression treatment approach for cancer survivors is non-inferior to guideline-concordant standard care in terms of depression treatment efficacy but superior for other key implementation outcomes (reach, cost-effectiveness, etc.). Our primary endpoint herein is feasibility of the stepped care approach among cancer survivors with elevated depressive symptoms. Secondarily, we will describe efficacy of the stepped care approach vs. guideline-concordant standard care.

Conditions
Cancer, Depression
Being tested
Behavioral Activation Therapy App, Telehealth Delivered Behavioral Activation
Medical subject headings
Neoplasms, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral Activation Therapy AppBehavioural

    Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures at weeks 12, 16, 20, and 24 post-randomization.

  • Telehealth Delivered Behavioral ActivationBehavioural

    8 sessions of telehealth-delivered Behavioral Activation with a mental health provider over a 10-week period.

Study groups in NCT06930729
Study groupRoleWhat they receive
Digitally-Enhanced Stepped CareExperimentalParticipants randomized to the Digitally-Enhanced Stepped Care condition will be instructed to utilize a Behavioral Activation therapy focused mobile application called "Moodivate" regularly, at least once per day, for the treatment of depressed mood among cancer survivors. Participants in the Digitally-Enhanced Stepped Care group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures at weeks 12, 16, 20, and 24 post-randomization. App engagement will be passively monitored for two weeks following initial download to determine whether care needs to be stepped up to guideline-concordant standard care.
Receives: Behavioral: Behavioral Activation Therapy App
Guideline-Concordant Standard CareActive comparatorParticipants randomized to the Guideline-Concordant Standard Care condition will receive 8 sessions of telehealth-delivered Behavioral Activation therapy with a mental health provider over a 10 week period. Participants will be asked to complete questionnaire measures at weeks 12, 16, 20, and 24 post-randomization.
Receives: Behavioral: Telehealth Delivered Behavioral Activation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of a digitally-enhanced stepped care approach to depression treatment among cancer survivors.

    Feasibility will be defined as either use of the digital mental health intervention (DMHI) at least once per week for >4 weeks (for DMHI engagers) or attendance at >4 therapy sessions (for DMHI non-engagers). Digitally-enhanced stepped care will be considered feasible if >80% of participants meet feasibility benchmarks.

    Measured: 24 weeks

Secondary outcomes (1)
  1. Efficacy of digitally-enhanced stepped depression care as compared to guideline-concordant standard care among cancer survivors

    Descriptive change in Patient Health Questionnaire (PHQ-9) from baseline through 24 weeks in depressive symptoms as a function of randomization group.

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2025
  2. Study start12 Aug 2025
  3. Primary completion22 Sep 2026
  4. Study completion22 Sep 2026

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06930729
Sponsor's protocol ID
Pro00142262
Other IDs
R01CA281740
Status last verified
Oct 2026
First submitted
9 Apr 2025
Last updated
13 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Activation Therapy App and Telehealth Delivered Behavioral Activation 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 13 Oct 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of a digitally-enhanced stepped care approach to depression treatment among cancer survivors. (time frame: 24 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 13 Oct 2026.

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Clinical Trial NCT06930729 | AzTrials