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CancerFACENCT01670461

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

A study testing FACE in people with Cancer, run by Maureen Lyon at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
FACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Jan 2009to Jun 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

Other trials in United States

About this study

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.

Read the 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.

Conditions
Cancer
Being tested
FACE, Standard of Care (SOC) Control
Keywords
advance care planning, palliative care, pediatric
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FACEBehavioural

    Also called FAmily CEntered (FACE) Advance Care Planning

    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©.

  • Standard of Care (SOC) ControlBehavioural

    Also called Standard of Care Control plus Information

    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.

Study groups in NCT01670461
Study groupRoleWhat they receive
FACE Advance Care PlanningExperimentalFACE 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©.
Receives: Behavioral: FACE
Standard of Care (SOC) ControlOtherStandard of Care Control: Advance Directive Information Booklet plus Advance Directive Checklist.
Receives: Behavioral: Standard of Care (SOC) Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 3

Secondary outcomes (2)

  1. 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.

    Measured: Week 2, 3 and 4

  2. 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).

    Measured: Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2012 (estimated)
  2. Study startJan 2009
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01670461
Sponsor's protocol ID
PEP-10-171-01-PCSM
Acronym
FACE
Status last verified
Mar 2019
First submitted
17 Aug 2012
Last updated
8 Mar 2019
Results posted
No
Data monitoring committee
No

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.

    PubMed 23479062

  • 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.

    PubMed 25545105

  • 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.

    PubMed 24411819

  • 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.

    PubMed 30829829

Questions about this trial

What is this clinical trial studying?

A study testing FACE in people with Cancer, run by Maureen Lyon at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Statement of Treatment Preferences (time frame: Week 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01670461, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.

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