Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582784
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
IMPACT IMproving Proactive Approaches for Cancer Survivors Mental Health Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living with Likely Incurable Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT
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 23 of participants enrolled will receive the mobile app and the remaining 13 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 andor loss of confidentiality Alternative treatments include contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood
Participants will be randomly assigned to either download the mobile app Moodivate or not Approximately 23 of participants enrolled will receive the mobile app and the remaining 13 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 andor loss of confidentiality Alternative treatments include contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood
Detailed Description:
Individuals living with likely incurable cancer ILLIC are a heterogeneous growing subpopulation of cancer survivors who live with cancer as a chronic relapsing disease As a result of their transitions through multiple lines of cancer therapy and prognostic uncertainty ILLIC have unique survivorship care needs Principal among these is the need for depression treatment Up to half of ILLIC report depressive symptoms with negative sequalae including lower quality of life reduced adherence to anti-cancer therapies suicidal ideation and desire for hastened death Numerous trials and meta-analyses have documented that evidence-based psychosocial treatment improves depression outcomes for ILLIC However multilevel barriers including transportation issues stigma and a scarcity of oncology mental health providers limit access Thus ILLIC need feasible accessible evidence-based depression treatment options3
Consistent with Commission on Cancer accreditation standards short depression screeners eg 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 ie 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 eg 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 N15 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
Consistent with Commission on Cancer accreditation standards short depression screeners eg 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 ie 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 eg 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 N15 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None