Optimizing Care for Cancer Survivors With Depression: Project 3

NCT06930729 | Recruiting

• 2 other identifiers: Pro00142262R01CA281740
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Depression

Outcome Measures

Primary Outcomes (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.

  24 weeks

Secondary Outcomes (1)

• Efficacy of digitally-enhanced stepped depression care as compared to guideline-concordant standard care among cancer survivors

  24 Weeks

Study Arms (2)

Digitally-Enhanced Stepped Care

EXPERIMENTAL

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.

Behavioral: Behavioral Activation Therapy App

Guideline-Concordant Standard Care

ACTIVE COMPARATOR

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.

Behavioral: Telehealth Delivered Behavioral Activation

Interventions

Behavioral Activation Therapy App 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.

Digitally-Enhanced Stepped Care

Telehealth Delivered Behavioral Activation BEHAVIORAL

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

Guideline-Concordant Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jennifer Dahne, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Levins

CONTACT

843-792-3681; levins@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: August 12, 2025
• Primary Completion: May 15, 2026
• Study Completion: May 15, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

US (1)