This is a non-therapeutic clinical trial for adolescents and young adult (AYA) oncology patients between the ages of 14 and 21 and their legal guardians or identified surrogate decision makers.
Advance Care Planning (ACP) prepares patients and their loved ones for future health care decisions, including care needed at end of life (EOL). The preferences of AYA patients with cancer when participating in ACP are not well studied. In this study, researchers will test a model of ACP that anticipates these issues, fully empowers the AYA and their legal guardians or identified surrogate decision makers, and keeps the role of health care professionals central. The goal is to develop an international model of structured pediatric advance care planning, which can be used as part of pediatric palliative care from the time of diagnosis to the EOL.
FACE-TC will give adolescents living with cancer a voice in their own end-of-life care with the support of their families or identified surrogate decision makers. This study will let researchers know what patients’ choices are and whether
- their choices stay the same over time
- religious experiences and beliefs influence their choices
- choices across racial groups are different or the same
To facilitate conversations about EOL care between adolescents and their legal guardians or surrogates in order to
- increase congruence in treatment preferences
- decrease decisional conflict/regret, while supporting plans and actions, psychological adjustment, and quality of life
- After completion of several psychological screening measures, participant dyads will be randomized to two arms of the study: an intervention group and a standard-of-care comparison group.
- The intervention arm will consist of three 60-to 90-minute sessions in a dyadic format with a certified, trained interviewer. It will include:
- training on ACP documents,
- questions to facilitate future conversations with families and healthcare providers, and
- opportunities to complete the Five Wishes© ACP tool and the Statement of Treatment Preferences, both entered into the patient’s medical record.
- After each session, the interviewer will administer a 15-minute assessment to document participants’ ratings of the quality of the communication with the facilitator and satisfaction (negative and positive emotions in response to the session) on a Likert scale.
- A blinded research assistant-assessor (not the intervention facilitator) will conduct follow-up sessions at 3-, 6, 12 and 18 months post-intervention, during which a variety of validated process measures will be administered (which either the AYA, the family member/surrogate or both will complete) in order to evaluate:
- presence of depression and severity of symptoms reported (Beck Depression Inventory-II)
- spiritual quality of life (Spiritual Well-Being Scale of the Functional Assessment of Chronic Illness Therapy-Version 4 instrument)
- spiritual function (i.e. religious experiences, values and beliefs, using the Brief Multidimensional measurement of religiousness/Spirituality or BMMRS-adapted version scale)
- health-related and psychological quality of life (Patient-Reported Outcomes Measurement Information System instrument)
- severity of subjective, somatic and panic-related symptoms of anxiety (Beck Anxiety Index)
- A standard-of-care comparison group will also be assessed and the same outcome measures administered at the same time intervals.
- Behavioral: FACE-TC
- Behavioral: Standard of Care (control)
Inclusion Criteria for Adolescents/Young Adults include:
- Diagnosed with cancer and aware of cancer status
- Between 14 and 21 years old
- Speaks English
- Absence of depression in the severe range or (>29) on Beck Depression Inventory II or score of two or three on item 9 assessing suicidality
- Willing to discuss problems related to cancer with legal guardian
Exclusion Criteria Adolescents/Young Adults include:
- In Intensive Care Unit
- In foster care
- Homicidal, suicidal, depressed, mentally impaired at time of screening
- Developmentally delayed
Inclusion Criteria for Legal Guardians/Surrogates include:
- Legal guardian of assenting adolescent participant
- Aware of cancer status of adolescent
- 18 years of age or older at time of enrollment
- Speaks English
- Surrogate was selected by the AYA who is aged 18 to 21
- Willing to discuss problems related to cancer and end of life
- Absence of depression in the moderate to severe range or (>29) on Beck Depression Inventory or score of one on item 9 assessing suicidality
About the Clinical Trial
In this study, researchers will talk to adolescents and young adults (AYA) oncology patients about their wishes regarding care at the end of life. This is also known as an advance directive, living will or Advanced Care Planning. Although there have been many studies done for adults about this topic, the preferences of AYA patients with cancer when participating in ACP are not well studied.
The researchers want to determine, throughout the course of the AYA’s illness
- whether and how AYA patient’s wants and needs change over time
- if the AYA patient’s family and/or surrogate decision makers also adjust their understanding of the AYA patient’s changing preferences
- whether their doctors provide medically appropriate care at end of life in accordance with the AYA patient’s expressed wishes as much as possible
Researchers will also help
- AYA patients and their families/surrogate decision makers learn how to talk with each other and their doctors about their wishes for end-of-life care
- help them prepare a plan for the future to be placed in their medical records and shared with their entire healthcare team
FACE-TC Quick View Sponsors Children’s National Health System
George Washington University School of Medicine and Public Health
ClinicalTrials.gov identifier NCT02693665 Trial Start Date September 2, 2015 Estimated Enrollment 390 Study Type Non-therapeutic, prospective Condition Cancer Ages Between 14 and 21 years of age Principal Investigators Justin Baker, M.D.; Maureen Lyon, M.D. (Children’s National Health System); Sarah Friebert, M.D. (Akron Children’s Hospital) Study Sites St. Jude; Akron Children’s Hospital, Ohio
St. Jude Children’s Research Hospital
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Memphis, TN 38105 USA
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