Health Equity: Advance Care Planning for Spanish Speaking Teens With Cancer-1st Resubmission

NCT04095000 | Completed DMC

• 1 other identifier: IRB 11473
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric ACP (Advance Care Planning) (pACP) (1) Supports communication with children/adolescents at any stage of a serious illness in understanding their illness, complications, fears, and hopes, as well as treatment preferences regarding future medical care with their family; (2) Communicates these goals of care and treatment preferences with their physician; and (3) Documents these goals of care and end-of-life treatment preferences. Among adolescents, cancer is the leading cause of disease-related deaths. Survival has improved far less for 15 to 24 year-olds than it has for older patients. About one-fourth will die prematurely. No pediatric Advance Care Planning (pACP) model exists to serve Spanish speaking adolescents with cancer. Objective: To take first steps to implement pACP as a routine, structured intervention in pediatric hospitals with underserved Spanish speaking adolescents living with cancer through timely conversations with their families to relieve suffering (physical, psychological, spiritual) and maximize the quality of life

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

• Development/Adaptation FACE TC for Spanish Speaking Teens

  Adapting and tailoring this evidence-based intervention will be accomplished through well-established techniques. The community partner interviews will be achieved through our youth with cancer, families affected by cancer and community stakeholders. Logic modeling based on our previous research and a literature review is completed. Study 1: Adolescent Focus Group: Do Hispanic/Latino Adolescents and Families Want to Be Involved in pediatric Advance Care Planning? We will conduct a 60 minute audio-taped focus group with five teens with cancer, ages 14-17, regarding what they would want and need when it comes to EOL care, as we have with our previous adaptations/development.11,59 We will review the English speaking version of the FACE protocol for changes (e.g. number of sessions, Five Wishes vs. Voicing My Choices).

  6 months

• Lyon Advance Care Planning Survey-Adolescent & Family Versions

  With the assistance of Children's National's Language Services (See Letter of Support) and our Hispanic chaplain and research staff we will translate and back translate the Lyon Advance Care Planning Survey-Adolescent and Surrogate version. We will then meet with adolescents with cancer and families to adapt/revise the survey (e.g. number of questions, best way to ask question, reading level).

  6 months

• Family Focus Group with Hispanic/Latino Families about Program Development

  Hispanic/Latino family members will be drawn from the Children's National Patient and Family Advisory Council (PFAC). We will conduct a 60 minute audio-taped focus group with Spanish speaking members. How should FACE-TC be adapted so as to be respectful of linguistic and cultural differences?

  6 months

• Critical Review of Revised Protocol

  Our community partners will meet in a Science Café to review the revised/adapted FACE-TC SP protocol. Rev. Roque will introduce the issues and the adapted study. We will explore thoughts, feelings and reactions until no new themes emerge and consensus is achieved.

  6 months

Secondary Outcomes (1)

• Pilot Test FACE-TC Spanish (FACE-TC Sp)

  24 months

Study Arms (2)

FACE-TC SP

EXPERIMENTAL

The current FACE-TC protocol consists of three weekly 60 to 90-minute sessions in a dyadic format facilitated by a trained/certified interviewer. If our community partners recommend otherwise, this structure could change. Each session is followed by a 10-minute assessment, using process measures to assess participants' ratings of the quality of communication and satisfaction.

Behavioral: FACE-TC SP

Treatment As Usual

ACTIVE COMPARATOR

Treatment as Usual comparison condition will also be assessed and measures administered at the same time intervals.

Behavioral: Treatment as Usual

Interventions

FACE-TC SP BEHAVIORAL

The current FACE-TC protocol consists of three weekly 60 to 90-minute sessions in a dyadic format facilitated by a trained/certified interviewer. If our community partners recommend otherwise, this structure could change. Each session is followed by a 10-minute assessment, using process measures to assess participants' ratings of the quality of communication and satisfaction.

FACE-TC SP

Treatment as Usual BEHAVIORAL

Treatment as Usual comparison condition will also be assessed and measures administered at the same time intervals.

Treatment As Usual

Eligibility Criteria

• Age: 14 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥14.0 years and \<21.0 years at the time of enrollment
• primary language is Spanish
• \>17 years

You may not qualify if:

• currently experiencing symptoms of depression in the severe range, homicidality, suicidality or psychosis at secondary screening
• known to be developmentally delayed

Sponsors & Collaborators

• Maureen Lyon: lead

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 22314, United States

Location

Related Publications (1)

• Lyon ME, Arem H, Jacobs S. Health disparities: Barriers to building effective palliative end-of-life care for Spanish speaking teens with cancer. Clinical Practice in Pediatric Psychology. CPP-2020-0439R1. In press.

  RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Therapeutics

Study Officials

• Maureen E Lyon, PhD

  Center for Translational Research/Children's Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: RA-Assessor will be blinded to randomization to reduce bias in collecting questionnaire data and data abstraction from electronic health record.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: This pilot will use a randomized control trial (RCT) design with the intent to treat. Randomization will be generated by computer to ensure the same numbers will be recruited to the FACE-TC Sp intervention and Treatment As Usual comparison group without bias, using a 1:1 ratio. We estimate that 32 adolescents ever diagnosed with cancer, aged 14 to 21, and 32 guardians/surrogates (N=64) will be enrolled and receive secondary screening. They will complete a Demographic Data Sheet. The assent/consent process focuses on readiness to participate, potential barriers to participation, as well as enhancing motivation. Adolescents and families will then be screened for eligibility. Eligible dyads, estimated to be 30 dyads, will complete baseline data. Then, the adolescent/family dyad will be randomly assigned to one of two conditions: 15 dyads will be assigned to FACE-TC SP and 15 dyads to Treatment As Usual.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: September 12, 2019
• Primary Completion: August 5, 2021
• Study Completion: August 5, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)