Building Evidence for Effective Palliative/End of Life Care for Teens With Cancer

NCT02693665 | Completed Results DMC

• 2 other identifiers: Pro000056481R01NR015458-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 4

Brief Summary

To test the efficacy of FACE-TC on key outcomes, the investigators propose using an intent-to-treat, longitudinal, prospective, multi-site, randomized controlled trial (RCT) design. Adolescents with cancer, aged 14 up to 20 years, and their families (N=130 dyads; N=260 participants) will be recruited and randomized to FACE-TC or Treatment as Usual (TAU) control. Participants will complete standardized questionnaires at baseline and 3, 6, 12, and 18 months post-intervention. Our goal is to assess the extent to which FACE-TC helps adolescents and young adults with cancer and their families: (1) reach and maintain better congruence in treatment preferences over time; (2) improve their quality of life; and (3) document goals of care and advance directives earlier in the course of their potentially life limiting illness.

Conditions

Cancer

Keywords

pediatric advance care planning; adolescent; family; palliative care; end of life; communication; decision making; surrogate decision maker; health care proxy; intervention; randomized clinical trial; cancer; quality of life; spiritual; religion; treatment congruence; treatment preferences; FAmily CEntered (FACE) Advance Care Planning

Outcome Measures

Primary Outcomes (1)

• Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care.

  Statement of Treatment Preferences documented adolescents' goals of care and families' understanding. Situations were: (1) prolonged hospital stay with ongoing medical intervention and low chance of survival; (2) treatments extend life by no more than 2-3 months with side-effects; (3) physical impairment; and (4) mental impairment. Choices for the four situations were "to continue all treatments …", "to stop all efforts to keep me alive…", or "do not know." Responses for data analysis were recoded into two categories: congruent (family accurately reported what the patient reported as their treatment preference) versus "stop all treatments." Dyadic responses, "do not know" were treated as not congruent and removed from analysis. Percentage dyadic agreement or disagreement was calculated for each situation. Minimum agreement is 0%. Maximum agreement is 100%. Higher percentage dyadic agreement is better outcome.

  Agreement on SOTP was assessed 2 weeks post-baseline for controls or immediately following Session 2 for FACE-TC intervention dyads, and at 3, 6, 12 and 18 months.

Secondary Outcomes (4)

• Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents.

  Change from baseline in quality of life (defined as symptoms of anxiety, depression, fatigue and pain interference) at 3, 6, and 12 months post baseline compared to controls

• Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX)

  Controlling for baseline, change in of meaning and peace subscale and faith subscale at 3, 6, 12 months post intervention for intervention adolescents compared to control adolescents. Total scores provided for interested investigators were not outcome.

• Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC)

  Baseline and 3 months post baseline administered to family surrogates only.

• Advance Directive for Adolescent Only Located in the Electronic Health Record at Study Close Out.

  This adolescent outcome was measured at one time point only, between 18 months post-intervention or study close-out. At study close out we had 117 adolescents in the study. Attrition was due to deaths, lost to follow-up, and withdrawals.

Other Outcomes (7)

• Quality of End of Life Communication (QOC)

  234 participants completed this assessment at two weeks post-baseline for control; two weeks post-baseline for intervention--immediately following Session 2. This process assessment is not in the flow diagram because it is not an intervention outcome.

• Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted)

  Assessed at baseline and at 3, 6, and 12 months post-intervention.

• Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted)

  Change from baseline in religiousness/spirituality at 3, 6, and 12 months post baseline compared to controls

Study Arms (2)

FACE-TC Intervention

EXPERIMENTAL

Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive.

Behavioral: FAmily CEntered Advance Care Planning for Teens with Cancer

Treatment As Usual (TAU)

NO INTERVENTION

Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.

Interventions

FAmily CEntered Advance Care Planning for Teens with Cancer BEHAVIORAL

3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.

Also known as: FACE-TC

FACE-TC Intervention

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:

• Ever diagnosed with cancer;
• Knows his or her cancer status;
• Ages of 14 up to 20 years;
• Ability to speak English;
• Consent from the legal guardian for adolescents aged 14-17;
• Consent from a surrogate for adolescents aged 18-20;
• Assent from adolescent aged 14-17;
• Consent from adolescent aged 18-20;
• Legal guardian of assenting adolescent participant;
• Knows cancer status of adolescent;
• Adolescent willingness to discuss problems related to cancer with them;
• Age 18 or older;
• Ability to speak English;
• Consent to participate; Consent for his/her adolescent to participate;
• Selected by adolescent aged 18 to 20;

You may not qualify if:

• Developmental delay; foster care; active homicidality or suicidality, depression in the severe range

Sponsors & Collaborators

• Maureen Lyon: lead
• St. Jude Children's Research Hospital: collaborator
• Akron Children's Hospital: collaborator
• National Institute of Nursing Research (NINR): collaborator
• Masonic Cancer Center, University of Minnesota: collaborator

Study Sites (4)

Children's National Medical Center

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

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55455-2070, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-3678, United States

Location

Related Publications (35)

• Lyon ME, Jacobs S, Briggs L, Cheng YI, Wang J. A longitudinal, randomized, controlled trial of advance care planning for teens with cancer: anxiety, depression, quality of life, advance directives, spirituality. J Adolesc Health. 2014 Jun;54(6):710-7. doi: 10.1016/j.jadohealth.2013.10.206. Epub 2014 Jan 7.

  PMID: 24411819 BACKGROUND

• Lyon ME, Jacobs S, Briggs L, Cheng YI, Wang J. Family-centered advance care planning for teens with cancer. JAMA Pediatr. 2013 May;167(5):460-7. doi: 10.1001/jamapediatrics.2013.943.

  PMID: 23479062 BACKGROUND

• 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, 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, 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

• Jacobs S, Perez J, Cheng YI, Sill A, Wang J, Lyon ME. Adolescent end of life preferences and congruence with their parents' preferences: results of a survey of adolescents with cancer. Pediatr Blood Cancer. 2015 Apr;62(4):710-4. doi: 10.1002/pbc.25358. Epub 2014 Dec 24.

  PMID: 25545105 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

• Garvie PA, He J, Wang J, D'Angelo LJ, Lyon ME. An exploratory survey of end-of-life attitudes, beliefs, and experiences of adolescents with HIV/AIDS and their families. J Pain Symptom Manage. 2012 Sep;44(3):373-85.e29. doi: 10.1016/j.jpainsymman.2011.09.022. Epub 2012 Jul 7.

  PMID: 22771129 BACKGROUND

• Lyon ME, McCabe MA, Patel KM, D'Angelo LJ. What do adolescents want? An exploratory study regarding end-of-life decision-making. J Adolesc Health. 2004 Dec;35(6):529.e1-6. doi: 10.1016/j.jadohealth.2004.02.009.

  PMID: 15581537 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

• 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 BACKGROUND

• Weaver MS, Anderson B, Cole A, Lyon ME. Documentation of Advance Directives and Code Status in Electronic Medical Records to Honor Goals of Care. J Palliat Care. 2020 Oct;35(4):217-220. doi: 10.1177/0825859719860129. Epub 2019 Jul 7.

  PMID: 31280659 BACKGROUND

• Feudtner C, Rosenberg AR, Boss RD, Wiener L, Lyon ME, Hinds PS, Bluebond-Langner M, Wolfe J. Challenges and Priorities for Pediatric Palliative Care Research in the U.S. and Similar Practice Settings: Report From a Pediatric Palliative Care Research Network Workshop. J Pain Symptom Manage. 2019 Nov;58(5):909-917.e3. doi: 10.1016/j.jpainsymman.2019.08.011. Epub 2019 Aug 21.

  PMID: 31445136 BACKGROUND

• Watson A, Weaver M, Jacobs S, Lyon ME. Interdisciplinary Communication: Documentation of Advance Care Planning and End-of-Life Care in Adolescents and Young Adults With Cancer. J Hosp Palliat Nurs. 2019 Jun;21(3):215-222. doi: 10.1097/NJH.0000000000000512.

  PMID: 30829829 BACKGROUND

• Needle J, Brunnquel D, Lyon M. Mature minors, mature decisions: Advance care planning for adolescent patients with life-limiting illness. Journal of Pediatric Ethics! Advanced Care Planning and End of Life. 2018;1(3).

  BACKGROUND

• Weaver MS, Bell CJ, Diver JL, Jacobs S, Lyon ME, Mooney-Doyle K, Newman AR, Slutsman J, Hinds PS. Surprised by Benefit in Pediatric Palliative Care Research. Cancer Nurs. 2018 Jan/Feb;41(1):86-87. doi: 10.1097/NCC.0000000000000576. No abstract available.

  PMID: 29206683 BACKGROUND

• Needle JS, Peden-McAlpine C, Liaschenko J, Koschmann K, Sanders N, Smith A, Schellinger SE, Lyon ME. "Can you tell me why you made that choice?": A qualitative study of the influences on treatment decisions in advance care planning among adolescents and young adults undergoing bone marrow transplant. Palliat Med. 2020 Mar;34(3):281-290. doi: 10.1177/0269216319883977. Epub 2019 Oct 29.

  PMID: 31659933 BACKGROUND

• Wiener L, Zadeh BS, Battles H, Sender L, Fasciano K, Heath C, Lyon ME, Donavan KA, Naronoha Ferrazde Arruda Colli M, Pao M. Courageous Conversations: Advance Care Planning and Family Communication. Pediatric Blood & Cancer, S596, October, 2018

  BACKGROUND

• Curtin KB, Watson AE, Wang J, Okonkwo OC, Lyon ME. Pediatric advance care planning (pACP) for teens with cancer and their families: Design of a dyadic, longitudinal RCCT. Contemp Clin Trials. 2017 Nov;62:121-129. doi: 10.1016/j.cct.2017.08.016. Epub 2017 Aug 24.

  PMID: 28844985 RESULT

• Gaines ThompkinsJ, Friebert S, Baker J, Needle J, Cheng Y, Lyon M. Effect of FAmily CEntered (FACE) advance care planning (ACP) on families' appraisals of caregiving for their teens with cancer. J Pain Symptom Manage 2019;57(2):446-447. PMID: 30267845

  RESULT

• Friebert S, Gaines (Thompkins) J, Needle J, Baker J, Cheng Y, Lyon M. What do adolescents want? Values, goals and beliefs of teens with cancer. J Pain Symptom Manage 2019;57(2):378.

  RESULT

• Grossoehme DH, Friebert S, Baker JN, Tweddle M, Needle J, Chrastek J, Thompkins J, Wang J, Cheng YI, Lyon ME. Association of Religious and Spiritual Factors With Patient-Reported Outcomes of Anxiety, Depressive Symptoms, Fatigue, and Pain Interference Among Adolescents and Young Adults With Cancer. JAMA Netw Open. 2020 Jun 1;3(6):e206696. doi: 10.1001/jamanetworkopen.2020.6696.

  PMID: 32543698 RESULT

• Friebert S, Grossoehme DH, Baker JN, Needle J, Thompkins JD, Cheng YI, Wang J, Lyon ME. Congruence Gaps Between Adolescents With Cancer and Their Families Regarding Values, Goals, and Beliefs About End-of-Life Care. JAMA Netw Open. 2020 May 1;3(5):e205424. doi: 10.1001/jamanetworkopen.2020.5424.

  PMID: 32427325 RESULT

• Thompkins J, Baker JN, Friebert S, Needle J, Wang J, Cheng YI, Lyon ME. Effect of FAmily CEnterd (FACE) advance care planning (ACP) on families' appraisals of caregiving for their teen with cancer. 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. (ASCO Virtual Scientific Program). J Clin Oncol 38: 2020 (suppl; abstr e22533) DOI:10.1200/JCO.2020.38.15_suppl.e2253

  RESULT

• Schreiner K, Grossoehme DH, Friebert S, Baker JN, Needle J, Lyon ME. "Living life as if I never had cancer": A study of the meaning of living well in adolescents and young adults who have experienced cancer. Pediatr Blood Cancer. 2020 Oct;67(10):e28599. doi: 10.1002/pbc.28599. Epub 2020 Jul 19.

  PMID: 32686240 RESULT

• Livingston J, Cheng Y, Wang J, Tweddle T, Friebert S, Baker J, Thompkins J, Greenberg I, Lyon M. FP029 SIOP19-1654 Shared Spiritual Beliefs Between Adolescents with Cancer and Their Families: An Exploration of Social Determinants of Spiritual Well-Being. Supplement: Abstracts from the 51st Congress of the International Society of Paediatric Oncology (SIOP) Lyon, France, October 23-26, 2019 Pediatric Blood & Cancer. December 2019;66: IssueS4 e27989 https://doi.org/10.1002/pbc.27989

  RESULT

• Thompkins J, Greenberg I, Cheng Y, Baker J, Needle J, Friebert S, Tweddle M, Wang J, Lyon M. FP030 SIOP19-1630 The Influence of Religious Beliefs on Symptoms of Anxiety and Depression Among Adolescents with Cancer Supplement: Abstracts from the 51st Congress of the International Society of Paediatric Oncology (SIOP) Lyon, France, October 23-26, 2019 Pediatric Blood & Cancer. December 2019;66: IssueS4 e27989 https://doi.org/10.1002/pbc.27989

  RESULT

• Lyon ME, Grossoehme DH, Baker JN, Friebert S, Cheng Y, Chrastek J, Thompkins J, Tweddle M, Wang J, Needle J. Relationship of spiritual constructs to mental health PROs in adolescents with cancer.DOI: 10.1200/JCO.2019.37.31_suppl.136 Journal of Clinical Oncology 37, no. 31_suppl (November 01, 2019) 136-136. Published online November 25, 2019

  RESULT

• Needle JS, Friebert S, Thompkins JD, Grossoehme DH, Baker JN, Jiang J, Wang J, Lyon ME. Effect of the Family-Centered Advance Care Planning for Teens with Cancer Intervention on Sustainability of Congruence About End-of-Life Treatment Preferences: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2220696. doi: 10.1001/jamanetworkopen.2022.20696.

  PMID: 35819787 RESULT

• Baker JN, Friebert S, Needle J, Jiang J, Wang J, Lyon ME. An Intervention in Congruence for End-of-Life Treatment Preference: A Randomized Trial. Pediatrics. 2022 May 1;149(5):e2021054796. doi: 10.1542/peds.2021-054796.

  PMID: 35425986 RESULT

• Thompkins JD, Needle J, Baker JN, Briggs L, Cheng YI, Wang J, Friebert S, Lyon ME. Pediatric Advance Care Planning and Families' Positive Caregiving Appraisals: An RCT. Pediatrics. 2021 Jun;147(6):e2020029330. doi: 10.1542/peds.2020-029330. Epub 2021 May 6.

  PMID: 33958436 RESULT

• - Baker JN (presenter), Friebert S, Needle JS, Thompkins JD, Grossoehme D, Jiang J, Wang J, Lyon ME. Oral Presentation. The effect of Family-Centered pediatric Advance Care Planning for Teens with Cancer (FACE®-TC) on adolescents' decisional support, preparedness, and symptoms at 3- and 12- months post-intervention. 54th Congress of the International Society of Paediatric Oncologists (SIOP). September 29, 2022. Barcelona, Spain

  RESULT

• Lyon ME, Cheng YI, Needle J, Friebert S, Baker JN, Jiang J, Wang J. The intersectionality of gender and poverty on symptom suffering among adolescents with cancer. Pediatr Blood Cancer. 2021 Aug;68(8):e29144. doi: 10.1002/pbc.29144. Epub 2021 Jun 1.

  PMID: 34061435 RESULT

• Livingston J, Cheng YI, Wang J, Tweddle M, Friebert S, Baker JN, Thompkins J, Lyon ME. Shared spiritual beliefs between adolescents with cancer and their families. Pediatr Blood Cancer. 2020 Dec;67(12):e28696. doi: 10.1002/pbc.28696. Epub 2020 Sep 12.

  PMID: 32918519 RESULT

• Friebert S, Trujillo Rivera EA, Baker JN, Thompkins JD, Grossoehme D, Needle J, Lyon ME. Pediatric Advance Care Planning and Adolescent Preparedness and Quality of Life: An RCT. Pediatrics. 2025 Feb 1;155(2):e2024068699. doi: 10.1542/peds.2024-068699.

  PMID: 39821687 RESULT

MeSH Terms

Conditions

Neoplasms; Death; Communication; Facies

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Disease Attributes

Results Point of Contact

• Title: Dr. Maureen E. Lyon, PhD, Professor of Pediatrics, Principal Investigator
• Organization: Children's National Medical Center

mlyon@childrensnational.org

703-346-2873

Study Officials

• Maureen E Lyon, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Maureen E. Lyon, PhD, ABPP

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 29, 2016
• Study Start: July 16, 2016
• Primary Completion: April 30, 2021
• Study Completion: September 29, 2022
• Last Updated: May 8, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Estimated April 30, 2022
• Access Criteria: Graduate students in accredited programs, residents, fellows and faculty from accredited programs.

Locations

US (4)