N/A
N=126
Building Evidence for Effective Palliative/End of Life Care for Teens With Cancer
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02693665 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care. — 10; 22; 38; 19 Dyads — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FAmily CEntered Advance Care Planning for Teens with Cancer (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- Maureen Lyon
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care. |
10; 22; 38; 19; 25; 1 | <0.05 sig |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. |
13.0; 12.0; 10.0; 10.0; 16.0; 15.0 | <0.05 sig |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) |
28.0; 26.0; 12.0; 14.0; 78; 75.0 | <0.05 sig |
| SECONDARY Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) |
2.17; 2.34; 4.51; 4.61; 2.19; 2.44 | <0.05 sig |
| SECONDARY Advance Directive for Adolescent Only Located in the Electronic Health Record at Study Close Out. |
60; 8; 15; 34 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02693665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.