Optimizing Care for Cancer Survivors With Depression: Project 3

NCT ID: NCT06930729

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2026-05-15

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.

Conditions

Cancer; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Digitally-Enhanced Stepped Care

Participants 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.

Group Type: EXPERIMENTAL

Behavioral Activation Therapy App

Intervention Type: BEHAVIORAL

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.

Guideline-Concordant Standard Care

Participants 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.

Group Type: ACTIVE_COMPARATOR

Telehealth Delivered Behavioral Activation

Intervention Type: BEHAVIORAL

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

Interventions

Behavioral Activation Therapy App

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.

Intervention Type: BEHAVIORAL

Telehealth Delivered Behavioral Activation

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Dahne

Professor-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Dahne, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Olivia Levins

Role: CONTACT

levins@musc.edu

843-792-3681

Facility Contacts

Olivia Levins

Role: primary

levins@musc.edu

843-792-3681

Other Identifiers

R01CA281740

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00142262

Identifier Type: -

Identifier Source: org_study_id