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


N/A
14 Years
90 Years
Open (Enrolling)
Both
Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Statement of Treatment Preferences

Outcome Description:

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.

Outcome Time Frame:

Week 3

Safety Issue:

No

Principal Investigator

Maureen E Lyon, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Institutional Review Board

Study ID:

PEP-10-171-01-PCSM

NCT ID:

NCT01670461

Start Date:

January 2009

Completion Date:

June 2013

Related Keywords:

  • Cancer
  • advance care planning, palliative care, pediatric

Name

Location
Children's National Medical Center Washington, District of Columbia  20010-2970