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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: FACE
* Behavioral: Standard of Care (SOC) Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FACE Advance Care Planning<br>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<br>* 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©.<br>* Other names: FAmily CEntered (FACE) Advance Care Planning;|
| Other: Standard of Care (SOC) Control<br>Standard of Care Control: Advance Directive Information Booklet plus Advance Directive Checklist. | Behavioral: Standard of Care (SOC) Control<br>* 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.<br>* Other names: Standard of Care Control plus Information;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advance care planning, palliative care, pediatric