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
|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|
|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|
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.
- 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
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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
- 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
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
|Contact: Maureen E Lyon, PhDfirstname.lastname@example.org|
|Contact: Pamela S Hinds, PhDemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Jichuan Wang, PhD 202-476-2978 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Jason Jacobs 612-624-7718 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Kristine Allmendinger-Goertz, CCRC 330-543-5178 email@example.com|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105-3678|
|Contact: Justin Baker, MD 901-595-4446 firstname.lastname@example.org|
|Contact: Robin Wilcox 901-595-2658 email@example.com|
|Principal Investigator:||Maureen E Lyon, PhD||Children's Research Institute|