Clinical trial NCT06835764: A Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients
Official title: Enhancing Self-Efficacy and Lowering Anxiety Through a Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hospice
Caregivers
Keywords: videos
hospice family caregivers
education
telenovelas
self-efficacy
anxiety
feasibility
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Maryland Cigarette Restitution Fund
First posted: 2025-02-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HFCG Anxiety before and after NOVELA as assessed by the Generalized Anxiety Disorder 7-item scale
timeFrame: Baseline and 2 weeks
measure: Change in HFCG Self-efficacy before and after NOVELA as assessed by the Caregiver Self-Efficacy Scale
timeFrame: Baseline and 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Univeristy
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: DULCE CRUZ-OLIVER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crist JD, Pasvogel A, Hepworth JT, Koerner KM. The impact of a telenovela intervention on use of home health care services and Mexican American older adult and caregiver outcomes. Res Gerontol Nurs. 2015 Mar-Apr;8(2):62-76. doi: 10.3928/19404921-20150105-02. Epub 2015 Jan 16.
citation: Cruz-Oliver DM, Malmstrom TK, Fernandez N, Parikh M, Garcia J, Sanchez-Reilly S. Education Intervention "Caregivers Like Me" for Latino Family Caregivers Improved Attitudes Toward Professional Assistance at End-of-life Care. Am J Hosp Palliat Care. 2016 Jul;33(6):527-36. doi: 10.1177/1049909115584315. Epub 2015 May 27.
citation: Washington KT, Oliver DP, Benson JJ, Rolbiecki AJ, Jorgensen LA, Cruz-Oliver DM, Demiris G. Factors influencing engagement in an online support group for family caregivers of individuals with advanced cancer. J Psychosoc Oncol. 2020 May-Jun;38(3):235-250. doi: 10.1080/07347332.2019.1680592. Epub 2019 Nov 6.
citation: Cruz-Oliver DM, Abshire M, Budhathoki C, Oliver DP, Volandes A, Smith TJ. Reflections of Hospice Staff Members About Educating Hospice Family Caregivers Through Telenovela. Am J Hosp Palliat Care. 2021 Feb;38(2):161-168. doi: 10.1177/1049909120936169. Epub 2020 Jul 8.