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

Information source: Children's Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer

Intervention: FACE (Behavioral); Standard of Care (SOC) Control (Behavioral)

Phase: N/A

Status: Completed

Sponsored by: Maureen Lyon

Official(s) and/or principal investigator(s):
Maureen E Lyon, PhD, Principal Investigator, Affiliation: Children's Research Institute, Children's National Medical Center

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.

Clinical Details

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

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

Primary outcome: Statement of Treatment Preferences

Secondary outcome:

Quality of Patient-Interviewer Communication

Decisional Conflict Scale

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.

Eligibility

Minimum age: 14 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

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

Related 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.

Starting date: January 2009
Last updated: May 19, 2015

Page last updated: August 23, 2015

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