FAmily CEntered (FACE) Advance Care Planning for Teens With Cancer

NCT01670461 | Completed

• 1 other identifier: PEP-10-171-01-PCSM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Advance Care Planning (ACP) prepares patients and their loved ones for future health care decisions, including end-of-life decisions. Yet, the needs of adolescent oncology patients for participation in ACP, despite its priority, is not well studied. Our goal is to test a model of ACP that anticipates these issues, fully empowers the family and adolescent, and keeps the key role of health care professionals central, building on our earlier work. We hypothesized FAmily CEntered (FACE) ACP, would: (1) increase congruence in treatment preferences between adolescents and surrogates; (2) decrease decisional conflict for adolescents; and (3) increase quality of communication compared with controls.

Conditions

Cancer

Keywords

advance care planning, palliative care, pediatric

Outcome Measures

Primary Outcomes (1)

• Statement of Treatment Preferences

  Statement of Treatment Preferences expresses values and goals related to future decision making regarding frequently occurring scenarios common to individuals dying of cancer). This instrument will be used to document specific treatment preferences of patients and the surrogate's understanding of what the patient would want. Patients and surrogates choose one of three options, "to continue all treatment and keep fighting," "to stop all treatment to prolong my life," and "don't know." It can also be used to monitor changes in patient's preferences over time. This tool has been used in adults and in adolescents in the FACE study conducted by the PI.

  Week 3

Secondary Outcomes (2)

• Quality of Patient-Interviewer Communication

  Week 2, 3 and 4

• Decisional Conflict Scale

  Week 3

Other Outcomes (7)

• Beck Depression Inventory-II

  Week 1 and Month 4 (plus or minus one month)

• Beck Anxiety Index (BAI).

  Week 1 and Month 4 (plus or minus one month)

• Five Wishes©

  Week 4

Study Arms (2)

FACE Advance Care Planning

EXPERIMENTAL

FACE intervention goal is to facilitate conversations about EOL care between adolescents and their legal guardians/surrogates to increase congruence in treatment preferences, to decrease decisional conflict, while supporting plans and actions, psychological adjustment and quality of life. Three 60 to 90-minute sessions in a dyadic format with a trained/certified interviewer. Session 1. The Lyon Family Centered Advance Care Planning Survey©. Session 2. Respecting Choices® Family-Centered Cancer Specific ACP Interview. Session 3. Completion of Five Wishes©.

Behavioral: FACE

Standard of Care (SOC) Control

OTHER

Standard of Care Control: Advance Directive Information Booklet plus Advance Directive Checklist.

Behavioral: Standard of Care (SOC) Control

Interventions

FACE BEHAVIORAL

FACE intervention goal is to facilitate conversations about EOL care between adolescents and their legal guardians/surrogates to increase congruence in treatment preferences, to decrease decisional conflict, while supporting plans and actions, psychological adjustment and quality of life. Three 60 to 90-minute sessions in a dyadic format with a trained/certified interviewer. Session 1. The Lyon Family Centered Advance Care Planning Survey©. Session 2. Respecting Choices® Family-Centered Cancer Specific ACP Interview. Session 3. Completion of Five Wishes©.

Also known as: FAmily CEntered (FACE) Advance Care Planning

FACE Advance Care Planning

Standard of Care (SOC) Control BEHAVIORAL

Standard of Care (SOC) control will be provided with written information that encourages conversation the treatment team. At Children's National the following represent hospital policy: " … regarding advance directives … to honor each non-minor patient's wishes … to encourage and assist patients in determining and expressing their preferences regarding treatment decisions for use in the event they subsequently become unable to make such decisions." Upon admission if they do not have an advance directive, they should be given the "Advance Directive Information Booklet" and the Advance Directive Checklist. If they already have one, the patient is asked to provide a current copy, and it is placed in the medical record.

Also known as: Standard of Care Control plus Information

Standard of Care (SOC) Control

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥14.0 years and \<21.0 years for adolescents at enrollment;
• Age ≥ 21.0 years for surrogates at enrollment;
• IQ \> 70 or not known to be developmentally delayed;
• Depression score on Beck Depression Inventory, Second Edition (BDI-II) Total Score \< 26;
• Primary language English

You may not qualify if:

• In foster care;
• Developmentally delayed;
• Suicidal or homicidal or psychotic at time of screening;
• Not understand or speak English; and
• Failure on mini mental status exam

Sponsors & Collaborators

• Maureen Lyon: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Advance Care Planning; Standard of Care

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration; Quality Indicators, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Maureen E Lyon, PhD

  Children's Research Institute, Children's National Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Research Professor in Pediatrics

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: August 22, 2012
• Study Start: January 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

US (1)