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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: FACE; Behavioral: Standard of Care (SOC) Control

Detailed Description

Condition The purpose of the FACE intervention is to facilitate conversations about EOL care between adolescents and their legal guardians or surrogates in order to increase congruence in treatment preferences, to decrease decisional conflict, while supporting plans and actions, psychological adjustment and quality of life. This intervention will consist of three 60 to 90-minute sessions in a dyadic format with a trained/certified interviewer. Each session will be followed by a 15 minute assessment, using process measures to assess participants' ratings of the quality of the communication with the facilitator and satisfaction (negative and positive emotions in response to session) on a Likert scale. A research assistant, not the facilitator, will conduct the immediate post evaluation sessions. A Standard of Care comparison condition will also be assessed and measures administered at the same time intervals: at baseline, one week intervals for three weeks for process measures and Statement of Treatment Preferences, and at 3 month-post intervention follow-up.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010-2970
      • Children's National Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FACE Advance Care Planning; 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; 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©.; Other Names: FAmily CEntered (FACE) Advance Care Planning
OTHER: Standard of Care (SOC) Control; Standard of Care Control: Advance Directive Information Booklet plus Advance Directive Checklist.	Behavioral: Standard of Care (SOC) Control; 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.; Other Names: Standard of Care Control plus Information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Patient-Interviewer Communication	Quality of Patient-Interviewer Communication is a questionnaire to be administered independently to patient and parent/surrogate following Sessions 1, 2 and 3, regardless of randomization. This tool will be used to evaluate the quality of communication that occurs between the patient/guardian/surrogate and the HCP/interviewer. This instrument consists of four items to determine the quality of patient-clinician communication. Items are rated on a 3-point scale with degree from "no" to "definitely yes," meaning that the higher scores indicate the higher satisfaction with the quality of communication. Good internal consistencies have been reported in patients with AIDS (Cronbach's α = .81.	Week 2, 3 and 4
Decisional Conflict Scale	Decisional Conflict Scale is used to measure the degree of uncertainty about the course of action to take. The DSC consists of three subscales on a five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), e.g., "This decision was hard for me to make." The DSC demonstrated good test-retest item reliabilities (r≥.80).	Week 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory-II	Beck Depression Inventory-II (BDI-II)is a 21-item scale self-report measure to assess presence of symptoms of depression and severity of symptoms reported. This instrument has shown a high content, construct, and factorial validity and is appropriate for children and adolescents > 13 years of age. Reliability and validity are good.	Week 1 and Month 4 (plus or minus one month)
Beck Anxiety Index (BAI).	Beck Anxiety Index (BAI). This is a 21-item measure assessing severity of subjective, somatic, and panic-related symptoms of anxiety. Participants rate the degree of discomfort experienced as a result of each symptom over the past week on a 4-point Likert scale (range 0-3). Items are summed with a maximum possible score of 63. Scores of 0 to 7 indicate minimal anxiety, 8-15 indicate mild anxiety, 16-25 indicated moderate anxiety, and >26 indicate severe anxiety. Test-retest reliability for this measure is acceptable (r = .75) as is internal consistency reliability (α = .92). The BAI has also demonstrated adequate content, concurrent, construct, discriminant, and factorial validity. This measure was validated to clinically assess severity of anxiety in individuals aged 17 to 80, however will be extended to the younger age range of this study to allow for consistency of data collected by a single measure of anxiety.	Week 1 and Month 4 (plus or minus one month)
Five Wishes©	Five Wishes© (Towey, Aging with Dignity Component developed with support from The Robert Wood Johnson Foundation) is a legal document that facilitates having people express their treatment preferences if they were seriously ill or unable to communicate their wishes. The adolescent completed this along with their parent/proxy during the third experimental session. For adolescents under age 18, the Five Wishes© must be signed by their parent or legal guardian to be legally sufficient.	Week 4
Threat Appraisal Scale (TAS).	Threat Appraisal Scale (TAS)is a questionnaire administered to the adolescent during baseline assessment only. This measure will retrospectively estimate the adolescent's threat appraisal of cancer when adolescent learned of cancer diagnosis. Test-retest reliability for this measure ranges from .68 in younger children to .93 in older children. TAS scores are found to demonstrate a high degree of agreement with children's open-ended descriptions of negative life events, indicating adequate convergent validity of this measure. Theoretically, threat appraisal is related to Lazarus' concept of primary appraisal, particularly to the way in which the event threatens the child's commitments, goals, or values. Higher threat appraisals should lead to negative arousal and coping and to increased psychological symptoms.	Week 3
Spiritual Well Being Scale of the Functional Assessment of Chronic Illness Therapy - Version 4 (FACIT-Sp).	Spiritual Well Being Scale of the Functional Assessment of Chronic Illness Therapy - Version 4 (FACIT-Sp)is a questionnaire administered individually to both adolescent and guardian/surrogate. This measure will investigate spirituality as a protective process. This 23 item scale focuses primarily on the existential aspects of spirituality and faith. There are two subscales: meaning/peace and faith. The FACIT-SP has been used to study spirituality in teens with chronic illnesses.	Week 1 and Month 4 (plus or minus one month)
The Pediatric Quality of Life Inventory™ 4.0 (PedQL™ 4.0)	The Pediatric Quality of Life Inventory™ 4.0 (PedQL™ 4.0). Adolescent and parent/surrogate will complete independently the age-appropriate self-report version and the parent proxy report version. This is a 23-item modular instrument designed to measure health-related quality of life (HRQOL) in children and adolescents. It measures four dimensions of functional quality of life (Core Scales: Physical, Emotional, Social, School) applicable to pediatric populations with acute and chronic health conditions. This measure was selected, because it has the strongest norms, validity, and reliability of the measures available.	Week 1 and Month 4 (plus or minus one month)
Satisfaction Questionnaire	The Satisfaction Questionnaire assesses negative and postive emotional reactions to participating in the study on the part of the adolescent and the surrogate decision-maker/family member. It was designed specifcally for this study based on community based participatory research.	AWeek 2, 3 and 4

Collaborators and Investigators

• Sponsor: Maureen Lyon
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Maureen E Lyon, PhD, Children's Research Institute, Children's National Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: August 17, 2012
• First Submitted That Met QC Criteria: August 21, 2012
• First Posted (ESTIMATE): August 22, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: advance care planning, palliative care, pediatric
• Other Study ID Numbers: PEP-10-171-01-PCSM