IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)

NCT06582784 | Recruiting

• 2 other identifiers: Pro001374471R01CA281740-01A1
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors. Moodivate was developed by our research team to assist with the treatment of depressed mood. 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.

Conditions

Depression; Depressive Symptoms; Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Depression

  Change in the Patient Health Questionnaire (PHQ-9) score from baseline. The PHQ-9 scoring is 1-27 where 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, 15-19 is moderately severe depression, and 20-27 is severe depression.

  12 weeks

Secondary Outcomes (3)

• Change in Anxiety Symptoms

  12 weeks

• Change in Quality of Life

  12 weeks

• Clinical Response Rate

  12 weeks

Study Arms (2)

Treatment as Usual

OTHER

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.

Behavioral: Treatment as Usual

Moodivate

EXPERIMENTAL

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: Behavioral Activation Therapy App

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 weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.

Moodivate

Treatment as Usual BEHAVIORAL

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.

Treatment as Usual

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• 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

You may not qualify if:

• Current suicidal ideation at study screening, defined as a response greater than or equal to 1 on item nine of the PHQ-9
• 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

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

Depression; Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Jennifer Dahne, Ph.D.

CONTACT

843-876-2280; dahne@musc.edu

Noelle Natale

CONTACT

843-876-9457; natalen@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: Associate Professor-Faculty

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)