Clinical trial NCT06930729: Optimizing Care for Cancer Survivors With Depression: Project 3
Official title: Optimizing Care for Cancer Survivors With Depression (OASIS): Project 3
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Depression
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-04-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility of a digitally-enhanced stepped care approach to depression treatment among cancer survivors.
timeFrame: 24 weeks
Secondary outcomes:
measure: Efficacy of digitally-enhanced stepped depression care as compared to guideline-concordant standard care among cancer survivors
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jennifer Dahne, MD
role: PRINCIPAL_INVESTIGATOR
References: