Longitudinal Pediatric Palliative Care: Quality of Life & Spiritual Struggle

NCT01289444 | Completed DMC

• 1 other identifier: 1R01NR012711-01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

HIV

Keywords

palliative care; AIDS; adolescents; quality of life; adherence; spiritual; threat appraisal; treatment congruence; treatment preferences; dialysis; hospitalization; communication; family intervention; Family Centered Advance Care Planning; decision making; advance care planning; end of life

Outcome Measures

Primary Outcomes (1)

• congruence in treatment preferences

  Measured by the Statement of Treatment Preferences

  Change from baseline in Congruence in Treatment Preferences at 18 months post-intervention compared to control

Secondary Outcomes (3)

• QOL

  Change from baseline in Quality of Life at 18 months post-intervention compared to control

• Utilization of hospitalization

  Change from baseline in hospitalizations at 18 month follow-up post intervention compared to control

• Utilization of dialysis

  Change from baseline in use of dialysis at 18 month post-intervention compared to control

Study Arms (2)

Healthy Living Control

ACTIVE COMPARATOR

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

FAmily CEntered (FACE) ACP

EXPERIMENTAL

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

Interventions

FAmily CEntered (FACE) ACP BEHAVIORAL

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.

Also known as: FACE

FAmily CEntered (FACE) ACP

Healthy Living Control BEHAVIORAL

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.

Also known as: HLC

Healthy Living Control

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Adolescent willingness to discuss problems related to HIV/AIDS with them;
• Age 18 or older;

You may not qualify if:

• 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

Sponsors & Collaborators

• Maureen Lyon: lead
• St. Jude Children's Research Hospital: collaborator
• Johns Hopkins University: collaborator
• University of Miami: collaborator
• Howard University: collaborator
• Broward Health: collaborator

Study Sites (5)

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

Children's National Medical Center

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

Location

Children's Diagnostic & Treatment Center (Broward Health)

Fort Lauderdale, Florida, 33316, United States

Location

Univeristy of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (14)

• Lyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJ. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. J Palliat Med. 2009 Apr;12(4):363-72. doi: 10.1089/jpm.2008.0261.

  PMID: 19327074 BACKGROUND

• Lyon ME, Garvie PA, McCarter R, Briggs L, He J, D'Angelo LJ. Who will speak for me? Improving end-of-life decision-making for adolescents with HIV and their families. Pediatrics. 2009 Feb;123(2):e199-206. doi: 10.1542/peds.2008-2379.

  PMID: 19171571 BACKGROUND

• Lyon ME, Garvie PA, Briggs L, He J, Malow R, D'Angelo LJ, McCarter R. Is it safe? Talking to teens with HIV/AIDS about death and dying: a 3-month evaluation of Family Centered Advance Care (FACE) planning - anxiety, depression, quality of life. HIV AIDS (Auckl). 2010;2:27-37. doi: 10.2147/hiv.s7507. Epub 2010 Feb 18.

  PMID: 22096382 BACKGROUND

• Lyon ME, Garvie PA, Briggs L, He J, D'Angelo LJ, McCarter R. (September, 2010 on line, in press). Does spirituality protect psychological adjustment, quality of life or medication adherence when talking to HIV+ Adolescents about death and dying? Journal of Adolescent Health.

  BACKGROUND

• Wilkins ML, Dallas RH, Fanone KE, Lyon ME. Pediatric palliative care for youth with HIV/AIDS: systematic review of the literature. HIV AIDS (Auckl). 2013 Jul 29;5:165-79. doi: 10.2147/HIV.S44275. Print 2013.

  PMID: 23930080 BACKGROUND

• Rosenberg AR, Wolfe J, Wiener L, Lyon M, Feudtner C. Ethics, Emotions, and the Skills of Talking About Progressing Disease With Terminally Ill Adolescents: A Review. JAMA Pediatr. 2016 Dec 1;170(12):1216-1223. doi: 10.1001/jamapediatrics.2016.2142.

  PMID: 27749945 BACKGROUND

• Lee BC, et al. Who Will Speak for Me? Disparities in Palliative Care Research with Unbefriended Adolescents Living with HIV/AIDS. Journal of Palliative Medicine. 20(10), 2017. doi: 10.1089/jpm.207.0053

  BACKGROUND

• Dallas RH, Wilkins ML, Wang J, Garcia A, Lyon ME. Longitudinal Pediatric Palliative Care: Quality of Life & Spiritual Struggle (FACE): design and methods. Contemp Clin Trials. 2012 Sep;33(5):1033-43. doi: 10.1016/j.cct.2012.05.009. Epub 2012 Jun 1.

  PMID: 22664645 RESULT

• Dallas RH, Kimmel A, Wilkins ML, Rana S, Garcia A, Cheng YI, Wang J, Lyon ME; Adolescent Palliative Care Consortium.. Acceptability of Family-Centered Advanced Care Planning for Adolescents With HIV. Pediatrics. 2016 Dec;138(6):e20161854. doi: 10.1542/peds.2016-1854. Epub 2016 Nov 1.

  PMID: 27940700 RESULT

• Lyon ME, Kimmel AL, Cheng YI, Wang J. The Role of Religiousness/Spirituality in Health-Related Quality of Life Among Adolescents with HIV: A Latent Profile Analysis. J Relig Health. 2016 Oct;55(5):1688-99. doi: 10.1007/s10943-016-0238-3.

  PMID: 27071797 RESULT

• Lyon ME, D'Angelo LJ, Dallas RH, Hinds PS, Garvie PA, Wilkins ML, Garcia A, Briggs L, Flynn PM, Rana SR, Cheng YI, Wang J. A randomized clinical trial of adolescents with HIV/AIDS: pediatric advance care planning. AIDS Care. 2017 Oct;29(10):1287-1296. doi: 10.1080/09540121.2017.1308463. Epub 2017 Mar 30.

  PMID: 28359212 RESULT

• Lyon ME, Dallas RH, Garvie PA, Wilkins ML, Garcia A, Cheng YI, Wang J; Adolescent Palliative Care Consortium. Paediatric advance care planning survey: a cross-sectional examination of congruence and discordance between adolescents with HIV/AIDS and their families. BMJ Support Palliat Care. 2019 Mar;9(1):e22. doi: 10.1136/bmjspcare-2016-001224. Epub 2017 Sep 21.

  PMID: 28935629 RESULT

• Lyon ME, Garvie PA, D'Angelo LJ, Dallas RH, Briggs L, Flynn PM, Garcia A, Cheng YI, Wang J; Adolescent Palliative Care Consortium. Advance Care Planning and HIV Symptoms in Adolescence. Pediatrics. 2018 Nov;142(5):e20173869. doi: 10.1542/peds.2017-3869. Epub 2018 Oct 19.

  PMID: 30341154 RESULT

• Lyon ME, D'Angelo LJ, Cheng YI, Dallas RH, Garvie PA, Wang J; Adolescent Palliative Care Consortium. The influence of religious beliefs and practices on health care decision-making among HIV positive adolescents. AIDS Care. 2020 Jul;32(7):896-900. doi: 10.1080/09540121.2019.1668523. Epub 2019 Sep 19.

  PMID: 31535560 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Communication; Death

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maureen E Lyon, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: February 3, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: September 1, 2017 to September 1, 2020
• Access Criteria: Graduate students in accredited programs, residents, fellows, faculty in accredited programs.

Locations

US (5)