Clinical trial NCT01670461: FAmily CEntered (FACE) Advance Care Planning for Teens With Cancer
Official title: FAmily CEntered (FACE) Advance Care Planning for Teens With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: advance care planning, palliative care, pediatric
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2012-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Statement of Treatment Preferences
timeFrame: Week 3
Secondary outcomes:
measure: Quality of Patient-Interviewer Communication
timeFrame: Week 2, 3 and 4
measure: Decisional Conflict Scale
timeFrame: Week 3
Other outcomes:
measure: Beck Depression Inventory-II
timeFrame: Week 1 and Month 4 (plus or minus one month)
measure: Beck Anxiety Index (BAI).
timeFrame: Week 1 and Month 4 (plus or minus one month)
measure: Five Wishes©
timeFrame: Week 4
measure: Threat Appraisal Scale (TAS).
timeFrame: Week 3
measure: Spiritual Well Being Scale of the Functional Assessment of Chronic Illness Therapy - Version 4 (FACIT-Sp).
timeFrame: Week 1 and Month 4 (plus or minus one month)
measure: The Pediatric Quality of Life Inventory™ 4.0 (PedQL™ 4.0)
timeFrame: Week 1 and Month 4 (plus or minus one month)
measure: Satisfaction Questionnaire
timeFrame: AWeek 2, 3 and 4
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: Children's Research Institute, Children's National Medical Center
name: Maureen E Lyon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Watson A, Weaver M, Jacobs S, Lyon ME. Interdisciplinary Communication: Documentation of Advance Care Planning and End-of-Life Care in Adolescents and Young Adults With Cancer. J Hosp Palliat Nurs. 2019 Jun;21(3):215-222. doi: 10.1097/NJH.0000000000000512.