IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)
NCT ID: NCT06582784
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
279 participants
INTERVENTIONAL
2024-10-28
2029-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participants will be randomly assigned to either download the mobile app, "Moodivate", or not. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will not.
All participants will complete electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as your experiences using Moodivate and participating in this trial. Participation in this study will take about 12 weeks, beginning today.
Participation in this study may help in the treatment of future cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality. Alternative treatments include contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Cancer
NCT05932810
Optimizing Care for Cancer Survivors With Depression: Project 3
NCT06930729
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
NCT05574127
Text -Based Depression Screening Among Cancer Survivors
NCT06894849
Feasibility of a Technology-Based Intervention for Depression Referral Uptake in Cancer Survivors
NCT07091968
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Consistent with Commission on Cancer accreditation standards, short depression screeners (e.g., PHQ-2) are routinely administered in oncology settings with results recorded in structured Electronic Health Record (EHR) fields. Despite widespread screening adoption, treatment referral rates remain low (10-50%) across cancer centers. To address this depression screening vs. treatment referral gap, screening data can be used to proactively (i.e., remotely, outside an encounter) link survivors in need of depression treatment to scalable options. While depression screening data can be readily used for proactive identification (ID), as noted by NCI, there is a critical need to develop methods to identify and enumerate ILLIC. Data necessary to determine curability likelihood (e.g., advanced stage, metastatic), are typically recorded in unstructured EHR fields, necessitating labor-intensive, manual chart review to identify ILLIC. To realize the goal of delivering scalable evidence-based depression care for ILLIC, accurate, automated approaches to identify ILLIC are needed.
Self-guided digital mental health interventions (DMHIs) can be paired with proactive ID to create a scalable depression treatment delivery model. Our team recently developed "Moodivate" as a DMHI-based approach to deliver Behavioral Activation, an evidence-based first-line depression treatment for cancer survivors. In a pilot that informs this R01, we: 1) gathered stakeholder feedback and tailored Moodivate for the unique needs of ILLIC, 2) developed infrastructure and refined the approach for proactive ID of ILLIC with depression, and 3) conducted a pilot RCT (N=15) to evaluate feasibility, acceptability, and preliminary efficacy of a proactive ID + DMHI approach. In our RCT, ILLIC with depressive symptoms were proactively identified via structured (depression) and unstructured (ILLIC) EHR data, remotely enrolled, and randomized to proactive ID + DMHI (Moodivate tailored for ILLIC) or proactive ID + usual care (UC). Our preliminary data show that this care delivery model is feasible (60% of eligible patients accrued; Moodivate mean rating of excellent on the System Usability Scale), acceptable (70% used Moodivate continuously for one month), and may improve depression (40% reported a clinically meaningful improvement). Importantly, a sustainable treatment model must also address chronic evidence-to-practice gaps. Thus, implementation outcomes and determinants of the proactive ID + DMHI approach must be concurrently evaluated across multiple care delivery levels to enhance future adoption.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment as Usual
Participants in the treatment as usual group will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their oncology provider. Participants will be asked to complete questionnaire measures weekly for 8 weeks with a final follow up at 12 weeks.
Treatment as Usual
Participants will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their oncology provider. Participants will be asked to complete questionnaire measures weekly for 8 weeks with a final follow up at week 12.
Moodivate
Participants randomized to the Moodivate condition will be instructed to utilize Moodivate regularly, at least once per day, for the treatment of depressed mood among cancer survivors. Participants in the Moodivate 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 weekly for 8 weeks with a final follow up at week 12.
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 weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
Treatment as Usual
Participants will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their oncology provider. Participants will be asked to complete questionnaire measures weekly for 8 weeks with a final follow up at week 12.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ILLIC (as determined during manual chart review)
* Elevated depressive symptoms, defined as a score of ≥ 8 on the PHQ-9
* Current owner of an iOS- or Android-compatible smartphone
* Willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item)
* Have a valid e-mail address that is checked regularly or have regular access to text messages (to access follow-up assessments)
* English language fluency
Exclusion Criteria
* Severe cognitive impairment that precludes completion of informed consent. For the purposes of assessing eligibility, this criterion is operationalized as:
* Prior diagnosis of dementia, or Major Neurocognitive Disorder indicated either via self-report or in the EHR; or
* Self-report of cognitive difficulties that impair functional independence
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Medical University of South Carolina
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jennifer Dahne
Associate Professor-Faculty
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00137447
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.