Health Equity: Advance Care Planning for Spanish Speaking Teens With Cancer-1st Resubmission
Condition: Cancer
Study type: Interventional

Summary: 
      Pediatric ACP (Advance Care Planning) (pACP) (1) Supports communication with
      children/adolescents at any stage of a serious illness in understanding their illness,
      complications, fears, and hopes, as well as treatment preferences regarding future medical
      care with their family; (2) Communicates these goals of care and treatment preferences with
      their physician; and (3) Documents these goals of care and end-of-life treatment preferences.
      Among adolescents, cancer is the leading cause of disease-related deaths. Survival has
      improved far less for 15 to 24 year-olds than it has for older patients. About one-fourth
      will die prematurely. No pediatric Advance Care Planning (pACP) model exists to serve Spanish
      speaking adolescents with cancer.

      Objective: To take first steps to implement pACP as a routine, structured intervention in
      pediatric hospitals with underserved Spanish speaking adolescents living with cancer through
      timely conversations with their families to relieve suffering (physical, psychological,
      spiritual) and maximize the quality of life
    

Detailed description: 
      Non-English-speaking patients are far less likely to have advance care planning documents
      than English speakers. Some ethnicities in an adult study had no patients with an advance
      care planning document. Since completing advance care planning may increase early palliative
      care enrollment, as it did in the FACE-TC study, strategies to promote pACP are urgently
      needed, particularly with non-English speaking patients.

      Transactional stress and coping theory is the basis for the FACE intervention, because
      interventions can change the appraisal of an illness from that of a death threat to a
      challenge with potential for personal growth and mastery.

      Many adolescents want to talk about their goals and values regarding their own end-of-life
      care. These important discussions are often regarded as needed, but not initiated before a
      medical crisis, due to perceived (and unwarranted) fears they will cause anxiety, take away
      hope or cause physician or family discomfort. Parents who discussed death with their children
      who were dying of cancer reported no regrets. Pediatric ACP for adolescent cancer patients is
      a public health issue, because of its high burden and potential for the prevention of
      suffering, as most teen and young adult cancer patients at end of life get aggressive care.
      The proposed study will explore prospectively whether Hispanic/Latino teens can be safely
      supported to help them make informed choices with their families, advancing clinical
      practice. Heretofore, family refers to the legal guardian(s) or surrogate decision maker(s)
      of the adolescent patient with cancer.

      Age appropriate communication that includes the adolescent and family can facilitate
      decisions about medical treatments that precede death. Competency to participate in
      decision-making has been challenged by research on adolescent brain development, which
      demonstrates the structure of the adolescent brain is not fully formed.

      However, what these findings mean in terms of the actual functioning or behavior of an
      individual adolescent is unclear, stirring up legal and public policy debates. The
      implications for pACP are unclear. Empirical evidence and the ethical principles of justice
      and autonomy support the practice of including adolescents in decision-making about their
      future medical care, if they could not speak for themselves. Cognitive capacities required
      for "informed consent" for medical treatment exist in early adolescence. Nor is there reason
      to suspect that young adolescents have a less mature understanding of death: irreversibility;
      finality or non-functionality; universality or inevitability; and causality. Hinds and
      colleagues found that children with cancer realized they were involved in an end-of-life
      decision, understood the consequences of their decision (that death is the outcome no matter
      what), and could share the reasons for their preferences. The decision factors most
      frequently reported by pediatric patients were relationship based, while parents identified
      good communication. Parents also thought that communicating with the child about end-of-life
      preferences was appropriate when approached with sensitivity and care. The issues facing
      adolescents with a life-threatening illness are different from those facing adults, because
      minors' preferences are not legally binding.

      Culture and ethnicity are important in pACP. Cultural values differ with respect to patient
      autonomy. For those adolescents who do not want to defer these decisions to their family or
      physician, culturally sensitive pACP conversations may ensure patients and families feel
      cared for and supported, when there is full participation by the family and clear
      communication to the physician. Hospice surveys show one-third of Latinos opposed life
      support that prolonged suffering, leading the National Hospice and Palliative Care
      Organization to actively reach out to Latino communities. Immigrant status influences
      decisions about aggressive treatments, suggesting there may not be disparities in EOL care,
      but rather differences in preferences. Investigators will explore whether the number of years
      residing in the U.S. influences treatment choices among study participants.

      The FACE intervention is informed by the American Academy of Pediatrics, the Institute of
      Medicine (IOM), institutional guidelines, and evolving practice and theory recommending: (1)
      that decisions about end-of-life (EOL) care be shared among the adolescent patient, family,
      and physician; (2) that these discussions take place when the patient is stable; (3) and that
      decisions be individualized. In the SUPPORT study physicians misunderstood the patient's
      preferences about CPR in 80% of the cases. Clinical reports suggest that parents and
      physicians sometimes disregard adolescents' previously expressed wishes, particularly with
      regard to forgoing life-sustaining treatment. One of the goals of this intervention is to
      increase the congruence in treatment preferences between Spanish speaking adolescents with
      cancer and their families. Investigators also hope to resolve potential conflict about these
      decisions within the structure of the intervention through referrals to the ethics committee
      and chaplaincy program. One way the proposed FACE-TC Sp intervention differs from the SUPPORT
      study is that investigators include both the patient and surrogate in the decision-making
      process by actively engaging interested adolescents and families in facilitated conversations
      by a highly trained/certified interviewer about the end-of-life preferences that adolescents
      have.

      Only three pediatric ACP (pACP) programs are reported in the peer reviewed literature.1 A
      qualitative study, FOOTPRINTS™, focused on patients aged 8-20 years with Duchennes' Muscular
      Dystrophy. The second involved conversations between an ethicist and parents of children who
      were dying about the parent's goals for their child's care. Voicing My CHOICES™ is a model
      currently being tested with young adults by Wiener and colleagues. Investigators are
      exploring whether completion of an ACP document, by seriously ill young adults will foster
      future discussions with family and the physician regarding the young adult's personal goals,
      values or beliefs. Only Lyon's (PI) pilot study of FAmily CEntered ACP for Teens with Cancer
      (FACE-TC) employed a randomized controlled trial (RCT) to evaluate a structured pACP
      intervention. Adolescents/family dyads were randomized to FACE-TC Sp or a Treatment as Usual
      condition. See Preliminary Studies. In a systematic review of children's engagement in health
      related decisions, only the FACE pilot focused on children's participation in decisions about
      their medical care with their family. The FACE pACP approach offers the following advantages
      over other previous approaches. It is family-centered and disease-specific. It integrates the
      Representational Approach to Patient Education, which focuses first on assisting individuals
      to understand their medical condition, to explore values and goals, and to begin weighing the
      benefits and burdens of any life-sustaining treatment compared to personal/family values and
      goals. It is delivered by trained/certified facilitators. It focuses on promoting
      psychological well-being in the face of serious illness, consistent with the recommendations
      of Folkman. This inclusion of families is a core value of Spanish speaking families, as is
      religion. A majority of Hispanic adults (55%) say they are Catholic, while 16% are
      evangelical Protestants and 5% are mainline Protestants.

      The adaptation and pilot test of FACE-TC Sp will advance scientific knowledge by contributing
      to understanding what Hispanic/Latino adolescents living with cancer want with respect to
      goals of care and treatment preferences in the context of family support and enable us to put
      into practice recommended policies and understand how culture and spiritual experiences
      influence pACP outcomes.
    

Intervention name(s): FACE-TC SP; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The current FACE-TC protocol consists of three weekly 60 to 90-minute sessions in a dyadic format facilitated by a trained/certified interviewer. If our community partners recommend otherwise, this structure could change. Each session is followed by a 10-minute assessment, using process measures to assess participants' ratings of the quality of communication and satisfaction.; Treatment as Usual comparison condition will also be assessed and measures administered at the same time intervals.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This pilot will use a randomized control trial (RCT) design with the intent to treat. Randomization will be generated by computer to ensure the same numbers will be recruited to the FACE-TC Sp intervention and Treatment As Usual comparison group without bias, using a 1:1 ratio. We estimate that 32 adolescents ever diagnosed with cancer, aged 14 to 21, and 32 guardians/surrogates (N=64) will be enrolled and receive secondary screening. They will complete a Demographic Data Sheet. The assent/consent process focuses on readiness to participate, potential barriers to participation, as well as enhancing motivation. Adolescents and families will then be screened for eligibility. Eligible dyads, estimated to be 30 dyads, will complete baseline data. Then, the adolescent/family dyad will be randomly assigned to one of two conditions: 15 dyads will be assigned to FACE-TC SP and 15 dyads to Treatment As Usual.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care