Longitudinal Pediatric Palliative Care: Quality of Life & Spiritual Struggle (FACE)

October 5, 2021 updated by: Maureen Lyon

Our goal is to advance palliative care to adolescents and their families. We hope our study will decrease suffering (psychological, spiritual, physical) and increase quality of life (QOL). Left unprepared for end-of-life decisions, miscommunication and disagreements may result in families being charged with neglect or court battles over treatment choices. FAmily CEntered (FACE) Advance Care Planning helps prepare adolescents with HIV/AIDS and their families for future medical decisions. We hope to increase families' understanding of their teens' wishes for end-of-life care and to decrease conflict. We will also study communication and spiritual struggle Families will be randomized into the either the Control (N=65 families) or FACE Intervention (N=65 families). FACE families will meet with a trained/certified researcher for three 60- to 90-minute sessions scheduled one week apart: Session 1: Lyon Advance Care Planning Survey© - Adolescent and Surrogate Versions: Session 2: The Respecting Choices Interview® Session 3: Completion of The Five Wishes©. Control families will also meet with a researcher for three 60-to 90-minute sessions scheduled one week apart: Session 1: Developmental History, Session 2: Safety Tips, and Session 3: Nutrition. Questionnaires will be administered five times, when first seen, at 3, 6, 12 and 18 months from the time of Session 3. Hypothesis 1: Compared to an active control, FACE will relieve psychological suffering by 1) increasing congruence in treatment preferences between teens with AIDS and their surrogates, 2) decreasing decisional conflict regarding EOL decision making for future medical treatment in adolescents with AIDS; 3) increasing quality communication about EOL care in adolescent/legal guardian or surrogate dyads; 4) and maximizing QOL.

Hypothesis 2: In addition to the direct effects, FACE will also indirectly affect QOL through dimensions of threat appraisal.

Hypothesis 3: FACE will have stronger effects on the QOL measures among patients who have less spiritual struggle.

Hypothesis 4: Spiritual struggle has both direct and indirect effects on hospitalization/dialysis use. FACE will also affect hospitalization/dialysis use indirectly through threat appraisal and HAART adherence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our goal is to advance palliative care with children and their families aimed at relieving suffering (psychological, spiritual, physical) and maximizing quality of life. Left unprepared for end-of-life decisions, miscommunication and disagreements may result in families being charged with neglect, court battles and even legislative intervention. We propose building on our R34, evidence based model, the Family Centered (FACE) Advance Care Planning intervention, to test our full theoretical model examining the putative mediators and moderators, and spiritual struggle (negative religious coping) with a sicker group and adolescents with AIDS in an adequately powered randomized, clinical, 2-arm, controlled trial. FACE is a culturally sensitive and developmentally appropriate, manualized family intervention based on transactional stress and coping theory, which prepares adolescents with HIV/AIDS and their families for end-of-life decision-making through problem solving. Theoretically, threat appraisal is related to Lazarus' concept of primary appraisal, particularly the way in which an event threatens the child's goals or values. Spiritual struggle (negative religious coping) may be a source of distress, causing disparities in palliative care and outcomes. We will test the efficacy of the FACE intervention for increasing communication and congruence in end-of-life treatment preferences between teens with AIDS and their surrogates, and determine if increased congruence can be maintained over time. We will also examine the impact of the FACE intervention on decisional conflict, quality of communication, and patient quality of life. We will also evaluate hypothesized mediators (threat appraisal, HAART adherence) and moderator (spiritual struggle) of study outcomes, including hospitalizations. We will recruit from hospital-based clinics and randomize 130 adolescent/surrogate dyads (N=260 subjects) to either Control (N=65 dyads) or FACE Intervention (N=65 dyads). Participants with HIV dementia, severe depression, suicidality or homicidality or in foster care will not be allowed to participate. Three 60- to 90-minute sessions will be conducted with a certified interviewer at weekly intervals: FACE: Session 1: Lyon Advance Care Planning Survey© - Adolescent and Surrogate Versions: Session 2: The Respecting Choices Interview® Session 3: Completion of The Five Wishes©. Control will also be administered in a family group format to control for time, attention, and Hawthorn effects: Session 1: Developmental History, Session 2: Safety Tips, and Session 3: Safety Tips. Standardized self-report measures will be administered at baseline, immediate post intervention (3 month), and 6, 12 and 18 month post intervention. Generalized estimating equation (GEE) will assess outcomes.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University Hospital
      • Washington, District of Columbia, United States, 22314
        • Children's National Medical Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Children's Diagnostic & Treatment Center (Broward Health)
      • Miami, Florida, United States, 33136
        • Univeristy of Miami Miller School of Medicine
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Adolescent Inclusion Criteria:

  • Diagnosed ever with HIV;
  • All ethnic groups;
  • Knows HIV status;
  • Speaks English;
  • Absence of active homicidality or suicidality;
  • Absence of HIV dementia;
  • IQ >69;
  • Consent from the legal guardian for adolescents aged 14-17;
  • Consent from the surrogate for adolescents aged 18-21;
  • Assent from adolescent aged 14-17;
  • Consent from adolescent aged 18-21;
  • Absence of severe depression;
  • Not in foster care

Legal Guardian Inclusion Criteria for Legal Guardians of Adolescents Age 14-17:

  • Adolescent willingness to discuss problems related to HIV/AIDS with them;
  • Age 18 or older;
  • Ability to speak English;
  • Absence of active homicidality, suicidality, or psychosis;
  • Absence of HIV dementia;
  • Legal guardian;
  • Consent to participate; Consent for his/her adolescent to participate;
  • Knows HIV status of adolescent;
  • Absence of depression in the severe range;

Surrogate Inclusion Criteria for Adolescents Age 18-21:

  • Selected by adolescent aged 18 to 21;
  • Age 18 or older;
  • Willingness to discuss problems related to HIV and end-of-life;
  • Absence of active homicidality, suicidality, or psychosis;
  • Absence of HIV dementia;
  • Speaks English;
  • Consent to participate;
  • Knows HIV status of adolescent.
  • Absence of severe depression;

Exclusion Criteria:

  • adolescent or surrogate does not know HIV diagnosis
  • being in foster care
  • developmentally delayed
  • scoring below the cut off on the HIV Dementia Scale
  • scoring above the cut off for depressive symptoms on the Beck Depression Inventory
  • homicidal, suicidal or psychotic on screening
  • does not speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy Living Control

Session 1. Developmental History. Goal: To take a non-medical developmental history. The RA-Control will conduct the session in a structured interview format. Administered, with all medical questions removed to prevent any risk of contamination with the experimental condition.

Session 2. Safety Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures counseling guides. Participants will be asked questions about seat belt use, etc. Safety information will be provided.

Session 3. Nutrition Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures nutrition/counseling guides. The Administered by the trained RA-Control to prevent contamination with the FACE condition.
Behavioral: Healthy Living Control

Active Comparator: Three 60 to 90 minute sessions scheduled one week apart. 1. Developmental History. Goal: To take a non-medical developmental history. The RA-Control will conduct the session in a structured interview format. Administered with all medical questions removed to prevent any risk of contamination with the experimental condition. 2. Safety Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures counseling guides. Participants will be asked questions about seat belt use, etc. Safety information will be provided.

3. Nutrition Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures nutrition/counseling guides.

Other Names:
  • HLC
Experimental: FAmily CEntered (FACE) ACP
Three-60 to 90 minute sessions scheduled one week apart: 1) To assess values, spiritual and other beliefs, and life experiences with illness and EOL care & when to initiate advance care planning. 2) To facilitate conversations and shared decision-making between the adolescent and guardian/surrogate about palliative care & prepare the surrogate to be able to fully represent the adolescent's wishes. 3) Which person the teen wants to make health care decisions for him/her; The kind of medical treatment the teen wants; How comfortable the teen wants to be; How the teen wants people to treat him/her; What teen wants loved ones to know; Any spiritual or religious concerns teens may have.
Behavioral: FAmily CEntered (FACE) ACP
Three-60 to 90 minute sessions scheduled one week apart: 1) To assess values, spiritual and other beliefs, and life experiences with illness and EOL care & when to initiate advance care planning. 2) To facilitate conversations and shared decision-making between the adolescent and guardian/surrogate about palliative care & prepare the surrogate to be able to fully represent the adolescent's wishes. 3) Which person the teen wants to make health care decisions for him/her; The kind of medical treatment the teen wants; How comfortable the teen wants to be; How the teen wants people to treat him/her; What teen wants loved ones to know; Any spiritual or religious concerns teens may have.
Other Names:
  • FACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
congruence in treatment preferences
Time Frame: Change from baseline in Congruence in Treatment Preferences at 18 months post-intervention compared to control
Measured by the Statement of Treatment Preferences
Change from baseline in Congruence in Treatment Preferences at 18 months post-intervention compared to control

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QOL
Time Frame: Change from baseline in Quality of Life at 18 months post-intervention compared to control
Measured by score on Varni's Peds QoL
Change from baseline in Quality of Life at 18 months post-intervention compared to control
Utilization of hospitalization
Time Frame: Change from baseline in hospitalizations at 18 month follow-up post intervention compared to control
Hospitalization will be measured by chart review. Each site has hospital based services for patient population
Change from baseline in hospitalizations at 18 month follow-up post intervention compared to control
Utilization of dialysis
Time Frame: Change from baseline in use of dialysis at 18 month post-intervention compared to control
Use of dialysis will be measured by chart review.
Change from baseline in use of dialysis at 18 month post-intervention compared to control

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maureen Lyon

Collaborators

Johns Hopkins University
University of Miami
St. Jude Children's Research Hospital
Howard University
Broward Health

Investigators

  • Principal Investigator: Maureen E Lyon, PhD, Children's National Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 28, 2011

First Submitted That Met QC Criteria

February 2, 2011

First Posted (Estimate)

February 3, 2011

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R01NR012711-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data will be shared upon request to the PI after the close of the study.

IPD Sharing Time Frame

September 1, 2017 to September 1, 2020

IPD Sharing Access Criteria

Graduate students in accredited programs, residents, fellows, faculty in accredited programs.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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