This clinical trial compares the effect of Moodivate compared to mood management educational materials on symptoms of depression in patients with cancer which likely has no treatment currently available (incurable). Moodivate is a digital application (app) that focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood, reduce anxiety and improve the well-being and quality of life of cancer survivors. Educational material about mood management may be an effective method to help people learn about managing depressive symptoms. Moodivate may me more effective compared to mood management educational materials in reducing the severity of depression symptoms in patients with cancer that is likely incurable.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06582784.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South CarolinaStatus: Active
Contact: Jennifer Dahne
Phone: 843-876-2280
Florence
MUSC Health Florence Medical CenterStatus: Active
Contact: Jennifer Dahne
PRIMARY OBJECTIVE:
I. To examine the effectiveness of proactive identification (ID) + digital mental health intervention (DMHI) compared with proactive ID + usual care (UC) on depression symptom severity among individuals with likely incurable cancer (ILLIC) with depressive symptoms as measured by the change in the Patient Health Questionnaire (PHQ-9) score from baseline.
SECONDARY OBJECTIVES:
I. To examine the effectiveness of proactive ID + DMHI compared with proactive ID + UC on depressive symptoms among ILLIC as measured by the clinical response rate.
II. To examine the effectiveness of proactive ID + DMHI compared with proactive ID + UC on anxiety and quality of life among ILLIC with depressive symptoms as determined by the (1) change in the Hospital Anxiety and Depression Scale, Anxiety subscale score from baseline and (2) change in the Functional Assessment of Cancer Therapy-General score from baseline.
III. To evaluate implementation outcomes related to the appropriateness and feasibility of the proactive ID + DMHI approach.
IV. To evaluate implementation outcomes related to the acceptability of the proactive ID + DMHI approach.
V. To evaluate implementation outcomes related to adoption of the proactive ID + DMHI approach.
VI. To evaluate implementation outcomes related to fidelity of the proactive ID + DMHI approach.
EXPLORATORY OBJECTIVES:
I. To explore the relationship between group and potential treatment modifying effects of digital literacy and theoretically relevant cancer variables on the primary outcome of change in depressive symptoms.
II. To create an electronic health record (EHR)-derived ILLIC phenotype.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (PROACTIVE ID + DMHI): Patients access the Moodivate app to set goals and complete activities within those goals over 5-10 minutes at least once daily for up to 8-12 weeks. Patients receive reinforcement messages upon completion of activities. Patients may also receive depression treatments provided by oncology team per standard clinical care.
ARM II (ID + UC): Patients receive mood management educational materials and encouraged to discuss mood management with oncology care team. Patients may also receive depression treatments provided by oncology team per standard clinical care.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMedical University of South Carolina
Principal InvestigatorJennifer Dahne
