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Trial record 3 of 3 for:    19171571 [PUBMED-IDS]

Building Evidence for Effective Palliative/End of Life Care for Teens With Cancer (FACE-TC)

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ClinicalTrials.gov Identifier: NCT02693665
Recruitment Status : Recruiting
First Posted : February 29, 2016
Last Update Posted : August 31, 2017
Sponsor:
Collaborators:
St. Jude Children's Research Hospital
Akron Children's Hospital
National Institute of Nursing Research (NINR)
University of Minnesota Masonic Children's Hospital
Information provided by (Responsible Party):
Maureen Lyon, Children's Research Institute

Brief Summary:
To test the efficacy of FACE-TC on key outcomes, the investigators propose using an intent-to-treat, longitudinal, prospective, multi-site, randomized controlled trial (RCT) design. Adolescents with cancer, aged 14 up to 20 years, and their families (N=130 dyads; N=260 participants) will be recruited and randomized to FACE-TC or Treatment as Usual (TAU) control. Participants will complete standardized questionnaires at baseline and 3, 6, 12, and 18 months post-intervention. Our goal is to assess the extent to which FACE-TC helps adolescents and young adults with cancer and their families: (1) reach and maintain better congruence in treatment preferences over time; (2) improve their quality of life; and (3) document goals of care and advance directives earlier in the course of their potentially life limiting illness.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: FAmily CEntered Advance Care Planning for Teens with Cancer Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Building Evidence for Effective Palliative/End of Life Care for Teens With Cancer
Actual Study Start Date : July 15, 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: FACE-TC Intervention
Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent & Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive.
Behavioral: FAmily CEntered Advance Care Planning for Teens with Cancer
3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.
Other Name: FACE-TC

No Intervention: Treatment As Usual (TAU)
Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.



Primary Outcome Measures :
  1. Statement of Treatment Preferences [ Time Frame: Sustained congruence in treatment preferences at 3, 6, 12 and 18 months compared to controls ]
    Congruence in treatment preferences between adolescent and their family


Secondary Outcome Measures :
  1. PROMIS Short Forms [ Time Frame: Change from baseline in quality of life at 3, 6, 12 and 18 months post baseline compared to controls ]
    Assess adolescent Physical Function Mobility; Physical Function Upper Extremity; Emotional distress-Anxiety; Emotional Distress-Depressive Symptoms; Fatigue; and Pain Interference. 8 items each.

  2. Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) [ Time Frame: Change from baseline in spiritual quality of life at 3, 6, 12 and 18 months post baseline compared to controls ]
    Assess the construct of spiritual functioning and religious practices, e.g. religious preferences and practices, feeling God's presence. Nonreligious participants can pass on these items. 38 items.

  3. FACIT-Spirituality Version 4 [ Time Frame: Change from baseline in spiritual quality of life at 3, 6, 12 and 18 months post baseline compared to controls ]
    Assess construct of peace and spiritual well-being

  4. Beck Depression Inventory-II & Beck Anxiety Inventory [ Time Frame: Surrogate only Change from baseline in quality of life at 3, 6, 12 and 18 months post baseline compared to controls ]
    Assess depressed mood

  5. Family Appraisal of Caregiving Questionnaire for Palliative Care [ Time Frame: Baseline and 3, 6, 12, 18 months post baseline ]
    Assess caregiver strain, positive caregiving appraisals, caregiver distress, and family well-being.


Other Outcome Measures:
  1. Medical Chart Abstraction [ Time Frame: Baseline and at 3, 6, 12 and 18 months post baseline compared to controls ]
    Assess documentation of goals of care, advance directives and care received last week to last month of life.

  2. Quality of Facilitator and Adolescent/Family Communication [ Time Frame: Two weeks post-baseline for control; two weeks post-baseline for intervention--immediately following Session 2. ]
    To monitor quality of communication with dyads

  3. Satisfaction Questionnaire [ Time Frame: Two weeks post-baseline for control; two weeks post-baseline for intervention--immediately following Session 2. ]
    To assess adolescent and family satisfaction with participating in the study



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Ages Eligible for Study:   14 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

AYA Inclusion Criteria:

  • Ever diagnosed with cancer;
  • Knows his or her cancer status;
  • Ages of 14 up to 20 years;
  • Ability to speak English;
  • Consent from the legal guardian for adolescents aged 14-17;
  • Consent from a surrogate for adolescents aged 18-20;
  • Assent from adolescent aged 14-17;
  • Consent from adolescent aged 18-20;

Inclusion Criteria for Legal Guardians of Adolescents Age 14-17:

  • Legal guardian of assenting adolescent participant;
  • Knows cancer status of adolescent;
  • Adolescent willingness to discuss problems related to cancer with them;
  • Age 18 or older;
  • Ability to speak English;
  • Consent to participate; Consent for his/her adolescent to participate;

Inclusion Criteria for Surrogates of AYAs Age 18-20:

  • Selected by adolescent aged 18 to 20;
  • Knows cancer status of adolescent;
  • Age 18 or older;
  • Ability to speak English;
  • Willingness to discuss problems related to cancer and EOL;
  • Consent to participate;

Exclusion Criteria - for AYA or surrogate decision-maker:

Developmental delay; foster care; active homicidality or suicidality, depression in the severe range


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693665


Contacts
Contact: Maureen E Lyon, PhD 202-476-5442 mlyon@childrensnational.org
Contact: Pamela S Hinds, PhD 202-476-4432 pshinds@childrensnational.org

Locations
United States, District of Columbia
Children's National Medical Center Not yet recruiting
Washington, D.C., District of Columbia, United States, 22314
Contact: Maureen E Lyon, PhD    202-476-5442    mlyon@cnmc.org   
Contact: Jichuan Wang, PhD    202-476-2978    jiwang@cnmc.org   
Principal Investigator: Maureen E Lyon, PhD         
United States, Minnesota
University of Minnesota Masonic Children's Hospital Not yet recruiting
Minneapolis, Minnesota, United States, 55455-2070
Contact: Jennifer Needle, MD    612-624-9440    jneedle@umn.edu   
Contact: Jason Jacobs    612-624-7718    j-jaco@umn.edu   
Sub-Investigator: Brenda Weigel, MD, MSc         
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Sarah Friebert, MD    330-543-3343    sfriebert@chmca.org   
Contact: Kristine Allmendinger-Goertz, CCRC    330-543-5178    kallmendinger-goertz@chmca.org   
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105-3678
Contact: Justin Baker, MD    901-595-4446    justin.baker@stjude.org   
Contact: Robin Wilcox    901-595-2658    robin.wilcox@stjude.org   
Sponsors and Collaborators
Maureen Lyon
St. Jude Children's Research Hospital
Akron Children's Hospital
National Institute of Nursing Research (NINR)
University of Minnesota Masonic Children's Hospital
Investigators
Principal Investigator: Maureen E Lyon, PhD Children's Research Institute

Publications of Results:
Other Publications:

Responsible Party: Maureen Lyon, Maureen E. Lyon, PhD, ABPP, Children's Research Institute
ClinicalTrials.gov Identifier: NCT02693665     History of Changes
Other Study ID Numbers: IRBear#5648
1R01NR015458-01 ( U.S. NIH Grant/Contract )
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: No, only de-identified data.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Estimated July 2020
Access Criteria: Graduate students in accredited programs, residents, fellows and faculty from accredited programs.

Keywords provided by Maureen Lyon, Children's Research Institute:
pediatric advance care planning
adolescent
family
palliative care
end of life
communication
decision making
surrogate decision maker
health care proxy
intervention
randomized clinical trial
cancer
quality of life
spiritual
religion
treatment congruence
treatment preferences
FAmily CEntered (FACE) Advance Care Planning