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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: FACE; Behavioral: Standard of Care (SOC) Control

• Registration Number: NCT01670461
• Lead Sponsor: Maureen Lyon

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.

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-22
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FACE Advance Care Planning	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©.
Standard of Care (SOC) Control	Standard of Care (SOC) Control	Standard of Care Control: Advance Directive Information Booklet plus Advance Directive Checklist.

Primary Outcome Measures

Name	Time	Method
Statement of Treatment Preferences	Week 3	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Patient-Interviewer Communication	Week 2, 3 and 4	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.
Decisional Conflict Scale	Week 3	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).

Trial Locations

Locations (1)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States