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Clinical Trials/NCT01670461
NCT01670461
Completed
Not Applicable

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

Maureen Lyon1 site in 1 country60 target enrollmentJanuary 2009
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Maureen Lyon
Enrollment
60
Locations
1
Primary Endpoint
Statement of Treatment Preferences
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
June 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Maureen Lyon
Responsible Party
Sponsor Investigator
Principal Investigator

Maureen Lyon

Associate Research Professor in Pediatrics

Children's National Research Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

Statement of Treatment Preferences

Time Frame: 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 Outcomes

  • Quality of Patient-Interviewer Communication(Week 2, 3 and 4)
  • Decisional Conflict Scale(Week 3)

Study Sites (1)

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