A Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients

Not Applicable

Recruiting

• Conditions: Hospice; Caregivers

• Registration Number: NCT06835764
• Lead Sponsor: Johns Hopkins University

Brief Summary

This randomized clinical trial (RCT) intends to look at the preliminary efficacy of NOVELA (intervention group) in changing anxiety and self-efficacy compared to usual hospice care (control group). In the NOVELA intervention, hospice care will be enhanced with the telenovela videos for hospice family caregivers (HFCG) education during twice weekly hospice telehealth visits to prepare caregivers for proper use of hospice support and healthcare services.

Detailed Description

Telenovela is a television drama or soap opera that can be used to lead viewers to contemplate and discuss critical issues through video storytelling. Prior work showed informational telenovelas had a positive effect on Latino family caregivers' attitudes toward end-of-life (EOL) care services. The role of videos in hospice and palliative care shows significant promise, underscoring the videos as a mode of education for family caregivers that could potentially enhance caregiver's self-efficacy, decrease caregiver's anxiety, and reduce burnout. Despite the value of video education, many programs have failed to provide engaging material.

Based on input from HFCG, the investigators have produced a bilingual (Spanish and English version) four chapter telenovela video series (To Care/ El privilegio de cuidar) as part of NCI funded diversity supplement study. Founded upon extensive preliminary work, To Care portrays the journey of one hospice family as the family struggle with the hospice decision, pain management, decision-making, and finally the dying process. Averaging only 4:65 minutes, each chapter addresses one of these problems, validating family experiences and identifying potential solutions.

In a follow-up study, the investigators developed an interventionist-led conversation guide as a companion for the telenovela. The intervention, which includes the video series and the conversation guide, is named NOVELA (short for telenovela). The investigators preliminary single-arm trial found NOVELA feasible and acceptable in the hospice setting, with promising improvements in caregiver anxiety symptoms. Thus, storytelling and culturally tailored videos can be powerful tools to educate family caregivers of hospice patients. The overall expectation is that NOVELA will improve self-efficacy thus lowering anxiety in hospice family caregivers.

This proposal has the following aims:

* Specific Aim 1: Investigate the preliminary efficacy of delivering NOVELA to African American (AA) and Hispanic HFCGs of cancer patients.

* Specific Aim 2: Evaluate the benefits of NOVELA as perceived by hospice staff.

Study Timeline

• Study Start: 2024-12-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Identified family caregiver of patients enrolled in hospice
• Caregivers must be over the age of 18
• Without cognitive impairment
• With access to wireless device and internet.

Exclusion Criteria

• HFCG of patients that are actively dying
• Caregivers younger than 18 years
• With cognitive impairment
• Without internet access.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HFCG Anxiety before and after NOVELA as assessed by the Generalized Anxiety Disorder 7-item scale	Baseline and 2 weeks	Generalized Anxiety Disorder 7-item (GAD-7) scale. Family caregiver indicate the frequency participants have been bothered by generalized anxiety. 7-items, scale 0-3, score range 0-21; higher scores reflect higher anxiety.
Change in HFCG Self-efficacy before and after NOVELA as assessed by the Caregiver Self-Efficacy Scale	Baseline and 2 weeks	Caregiver Self-Efficacy Scale (CaSES) - 21-items, scale 1-4, score range 21-84; higher scores reflect higher self-efficacy.

Trial Locations

Locations (1)

Johns Hopkins Univeristy; 🇺🇸 Baltimore, Maryland, United States