Journal of Adolescent Health 54 (2014) 710e717www.jahonline.org Original article A Longitudinal, Randomized, Controlled Trial of Advance Care Planning for Teens With Cancer: Anxiety, Depression, Quality of Life, Advance Directives, Spirituality Maureen E. Lyon, Ph.D. a, *, Shana Jacobs, M.D. b, Linda Briggs, M.S.N., R.N. c, Yao Iris Cheng, M.S. d, and Jichuan Wang, Ph.D. d a Children’s National Health System, Division of Adolescent and Young Adult Medicine, Children’s Research Institute, Center for Translational Science and George Washington University School of Medicine and Health Sciences, Washington, DC b Children’s National Health System, Division of Oncology/Children’s Research Institute, Center for Cancer and Immunology Research and George Washington University School of Medicine and Health Sciences, Washington, DC c Gundersen Medical Foundation, Inc., La Crosse, Wisconsin d Children’s National Health System, Children’s Research Institute, Center for Translational Science, Division of Biostatistics and Study Methodology and Department of Epidemiology and Biostatistics, George Washington University School of Medicine and Health Sciences, Washington, DC Article history: Received July 13, 2013; Accepted October 28, 2013 Keywords: Adolescent; Advance care planning; Advance directive; African-American; Cancer; Communication; Decision making; End of life; Family intervention; Pediatric palliative care A B S T R A C T Purpose: To test the feasibility, acceptability and safety of a pediatric advance care planning intervention, Family-Centered Advance Care Planning for Teens With Cancer (FACE-TC). Methods: Adolescent (age 14e20years)/family dyads (N ¼ 30) with a cancer diagnosis participated in a two-armed, randomized, controlled trial. Exclusion criteria included severe depression and impaired mental status. Acceptability was measured by the Satisfaction Questionnaire. General Estimating Equations models assessed the impact of FACE-TC on 3-month post-intervention outcomes as measured by the Pediatric Quality of Life Inventory 4.0 Generic Core Scale, the Pediatric Quality of Life Inventory 4.0 Cancer-Specific Module, the Beck Depression and Anxiety Inventories, the Spiritual Well-Being Scale of the Functional Assessment of Chronic Illness TherapyeIV, and advance directive completion. Results: Acceptability was demonstrated with enrollment of 72% of eligible families, 100% attendance at all three sessions, 93% retention at 3-month post-intervention, and 100% data completion. Intervention families rated FACE-TC worthwhile (100%), whereas adolescents’ ratings increased over time (65%e82%). Adolescents’ anxiety decreased significantly from baseline to 3 months postintervention in both groups (b ¼ 5.6; p ¼ .0212). Low depressive symptom scores and high quality of life scores were maintained by adolescents in both groups. Advance directives were located easily in medical records (100% of FACE-TC adolescents vs. no controls). Oncologists received electronic copies. Total Spirituality scores (b ¼ 8.1; p ¼ .0296) were significantly higher among FACE-TC adolescents versus controls. The FACE-TC adolescents endorsed the best time to Disclaimer: The contents of this study are solely the responsibility of the authors and do not necessarily represent the official views of the National Center for Advancing Translational Sciences or the National Institutes of Health or the American Cancer Society. Conflicts of Interest: The Lyon Advance Care Planning Survey is copyrighted by the first author and is available free of charge by request at mlyon@ childrensnational.org. Linda Briggs, MSN, RN, receives no royalties for training IMPLICATIONS AND CONTRIBUTION Family-Centered Advance Care Planning for Teens With Cancer is the first randomized clinical trial of pediatric advance care planning involving adolescents with cancer. This structured model meets the World Health Organization, Institute of Medicine, and American Academy of Pediatrics recommendations for early palliative care that involves the patient, surrogate decision makers, and physicians, moving the field of pediatric advance care planning forward. facilitators to use the Respecting Choices tool. This training is provided by the non-for-profit Gundersen Health System, which does charge fees for the on-line and face-to-face trainings. * Address correspondence to: Maureen E. Lyon, Ph.D., Center for Translational Science, Children’s Research Institute, Children’s National Health System, Room M7658, 111 Michigan Avenue, N.W., Washington, DC 20010-2970. E-mail address:
[email protected] (M.E. Lyon). 1054-139X/$ e see front matter Ó 2014 Society for Adolescent Health and Medicine. All rights reserved. http://dx.doi.org/10.1016/j.jadohealth.2013.10.206 completeness of data >90%. 19% at diagnosis. ACP conversations are frequently not initiated before a medical crisis because of the strong emotions evoked [10] or fear of taking away hope [11]. and >90% rating sessions as worthwhile. An age-appropriate communication model that includes adolescents with cancer and their families in making decisions about medical treatments that frequently precede death was recently tested for efficacy in a randomized controlled trial [21].E. Many young adolescents have as mature an understanding of death as those aged 18 years [7]. prolong survival [15]. Palliative care (PC) currently exists in the context of a changing health care delivery system in which death is medicalized. court battles. Courageous adolescents willingly participated in highly structured. 25% when dying. This was the first protocol to test pACP using a randomized clinical trial [13. Lyon et al. only if they are 18 years of age. (The development of FACE-TC is described in Appendix 1. Nonetheless. clinical trial in which adolescent/family . evidence supports the practice of allowing adolescents to make decisions about their health. which adapted the HIV protocol for teens with cancer [20]. decreased decisional conflict. Standard hospital practice is for hospital administrative personnel to inquire about the presence of an advance directive when the patient is hospitalized. When Children Die. and improve quality of life and mood among surviving relatives [16]. The third is FACE for Teens With Cancer (FACE-TC).19]. Adolescents want a voice in choices for their end-of-life (EOL) care. (3) Adolescents in the intervention group will have significantly increased spirituality compared with controls. Methods From January 2010 through July 2012. Conclusions: Family-Centered Advance Care Planning for Teens With Cancer demonstrated feasibility and acceptability. a marker for safety.M. All rights reserved. Nevertheless. Advance care planning (ACP) is one dimension of palliative care that provides support in decision making about limiting burdensome medical interventions and advance directives. and a willingness to limit treatments in some situations compared with controls [20]. none when first ill or hospitalized. Building on these findings. a model specific to adolescent patients with human immunodeficiency virus (HIV) (age 14e21 years) and their family. Unique challenges also arise from the adolescentefamily dynamic if there are disagreements in treatment preferences. increase congruence in treatment preferences between patients and their surrogate decision makers [14]. Legal guardian(s) or surrogate decision maker(s) are referred to as family/families from this point forward. followed by completion of an advance directive accessible in their medical chart. a model of pACP and coordination specific to patients with muscular dystrophy (age 8e21 years) [17]. The landmark SUPPORT study demonstrated that focusing on advance directives alone is insufficient to ensure that patients’ treatment preferences are honored at EOL [8]. compared with controls. Challenges to pACP unique to adolescents include their emerging intellectual and emotional maturity [22]. First is FOOTPRINTS. Among children with cancer 72% of those without PC died in the ICU versus 21% of those with PC [2]. Four of five children with complex chronic conditions in the United States die in the hospital [1]. Second is Family-Centered (FACE) Advance Care Planning. (2) Adolescents in the intervention group will be significantly more likely to engage in a robust pACP session. Cancer remains the leading illness causing death for adolescents [24]. Our aim was to demonstrate the feasibility. which contrasts with empirically based research that early palliative care can instill hope [12]. Ó 2014 Society for Adolescent Health and Medicine.18. / Journal of Adolescent Health 54 (2014) 710e717 711 bring up end-of-life decisions: 19% before being sick. 53% had a “do not resuscitate” order at the time of death [25]. Under the age of 18 years. maintain psychological well-being [13]. attendance >80% at all three sessions. We explored the influence of pACP on spirituality. Effective EOL care is a public health issue because of cancer’s high symptom burden and the potential to prevent suffering [26]. Many physicians believe that this is too late to begin this conversation [21]. In a review of 95 medical records of children with cancer who died. recommends that these conversations become a routine and structured part of standard of care [7]. Cognitive capacities required to make informed treatment decisions do not differ from those of adults [23]. controlled. Predetermined benchmarks for acceptability were enrollment >50% of eligible families. and even legislative intervention [6]. research identified the critical importance of including the surrogate decision maker in structured conversations with the patient about the patients’ goals for EOL care [9]. Only three structured pediatric ACP (pACP) programs are reported for adolescents with complex chronic conditions. Avoidance of EOL conversations can lead to miscommunication and disagreements. The Institute of Medicine’s report. randomized. retention >80% at 3-month follow-up. particularly in the context of the adolescents’ lack of legal authority to make treatment decisions under the age of 18 years in most states [6]. indepth pediatric advance care planning conversations safely. the pACP process is often triggered during a medical crisis. if they cannot speak for themselves [3e5]. which can be found in the on-line version of this article. and safety of a highly structured pACP conversation with teens with cancer and their families. Hypotheses at 3-month post intervention follow-up were: (1) Adolescent/family dyads in the intervention will maintain or increase quality of life and psychological adjustment compared with controls.) Immediate outcomes for FACE-TC replicated the previous findings from FACE [13] of increased congruence in treatment preferences between adolescents and their families. because being diagnosed with a life-limiting illness can inspire reflections on death and spirituality. which incorporated communication of the results to their oncologist and placement of an advance directive in the medical record. The 3-month post-intervention outcomes of this study are reported here. Spiritual quality of life is another important aspect of PC among dying children [7]. which may result in families charged with neglect. and 38% for all of the above. we conducted a small. acceptability. “I find comfort/strength in my faith spiritual beliefs. the main effect of time represents the outcome change from baseline to the 3-month follow-up.” “I feel a sense of thankfulness for my life”). severe developmental delays. Visit 4 (Session 3). Exclusion criteria were severe depression. Providers did not discuss the study directly with patients. Cary. and school). ranging from “strongly disagree” to “strongly agree. and 3month follow-up). the better the spiritual well-being. The integrated Pediatric Quality of Life Cancer-Specific Module measured cancer symptoms. quality of life..” after each of the three intervention sessions. and 26e63. Eligibility was not based on prognosis. retention.. emotional. which was extended upward to allow for one measure across participants.g. Higher scores indicate higher satisfaction. and Visit 5: 3-month post-intervention followup.E. minimal. Higher scores indicate better quality of life. The higher the score. The Spiritual Well-Being Scale of the Functional Assessment of Chronic Illness TherapyeVersion 4 [34]. Analyses used SAS 9. and the outcome change may depend on intervention status. mild. or impaired mental status. There are two subscales: Meaning/Peace (Items 1e8 [e. Sessions 1e3. the Lyon Family-Centered Advance Care Planning Survey [27. the Five Wishes [30].28]. The Beck Anxiety Inventory [31] is a 21-item measure of anxiety rated on a 4-point Likert scale of symptoms over the past week. Treatment as usual control All participants were given an ACP education brochure during baseline. Measures Analysis Demographic data and diagnosis were collected from patient report and confirmed by chart review. / Journal of Adolescent Health 54 (2014) 710e717 dyads were computer-randomized to either study arm. using an intention-to-treat design. a 23-item scale. “I feel hopeful. The Beck Depression InventoryeII [32] is a 21-item scale selfreport assessing the presence of symptoms of depression over the past 2 weeks on a 4-point Likert scale for adolescents >13 years of age. homicidality. attendance.” “My illness has strengthened my faith or spiritual beliefs”]). Inc. The institutional review board reviewed and approved the curriculum/protocol and measures. Signed assent and consent were obtained before eligibility screening. Assessments were administered at the same five time points as intervention dyads (baseline. Visit 3 (Session 2). female graduate students.” “I feel forgiven for any harm I may have ever caused. Clinical score interpretation of levels of anxiety is: 0e7. social. Lyon et al. Data were missing for two dyads for the 3-month postintervention follow-up. which included an on-line ACP course. The Satisfaction Questionnaire was developed and pilottested for the FACE protocol with HIV-positive adolescents [18]. The GEE model accommodates longitudinal data with attrition. Procedures Potential participants were identified with the help of oncology physicians and other providers. a 2-day face-to-face training with role plays. being in foster care. 20e28. severe. and validation of skills through the submission of a role play video to ensure competency and fidelity in implementing the Respecting Choices Interview [30]. minimal. moderate. Five study visits were conducted in the hospital in-patient unit.9 years.712 M. Training also was provided for highly structured Sessions 1 and 3. severe. Enrollment. We conducted the 3-month outcomes analysis . were age 14e21 years. and had an available legal guardian (if <18 years of age) or family member who was at least 21 years of age. 8e15. 14e19. the main effect of time only represents the outcome change in the control group. In the GEE models. NC). Visit 2 (Session 1). Potential participants were either actively treated or in long-term care. Clinical score interpretation of levels of depression is: 0e13. Thirteen items are answered on a 5-point Likert scale. When the interaction between time and intervention is statistically significant.g. Outcome change in the intervention group is the sum of the time main effect and the interaction effect between time and intervention. Facilitators debriefed with the first author. psychosis. 60-minute sessions in a dyadic format with a trained or certified facilitator (Table 1). ethnically diverse. “I feel peaceful. 16e25. but was signed by the family to be legal. Family-Centered Advance Care Planning for Teens With Cancer consists of three weekly. We extended downward to age 14 years to allow for consistency of data collection. to avoid risk of coercion. and spirituality over a 3-month observation period was assessed using the Generalized Estimating Equation (GEE) models.. The Beck Anxiety Inventory has demonstrated reliability and validity to assess anxiety in individuals aged 17e80 years. Most patients were receiving cure-directed treatments.2 (SAS Institute. The impact of FACE-TC on psychological well-being. Research assistants approached the adolescent or family only after clearance with the treating physician. The Pediatric Quality of Life Inventory 4. One patient died and another was too ill to participate. and completeness of data were gathered from the study database. Trained or certified facilitators Facilitators were four part-time. suicidality. Facilitators were trained or certified through the Respecting Choices competency-based Disease-Specific ACP Facilitator course. Five Wishes [30] is a legal document that facilitates expression of treatment preferences and served as a tool to facilitate the participation of adolescents under age 18 years. Participants Data were collected from 30 adolescents and 30 family members. focuses primarily on the existential aspects of spirituality (e.g. or patient’s home: Visit 1: baseline assessment.0 Generic Core Scales [33] is a 23-item measure of health-related quality of life (physical. The second author then confirmed diagnosis and relapse status. the Respecting Choices Disease-Specific Advance Care Planning Interview [29]. Measures were administered separately to the adolescent and family by a research assistant who was not the facilitator. moderate. Inclusion criteria for adolescents were that they knew the diagnosis. mild.. Norms exist for up to age 18. outpatient clinic. and 29e63.” “I have a reason for living”]) and Faith (Items 9e12 [e. Gaps in information are identified and referrals are made. Feasibility We achieved benchmarks.” “This was a relief . depending on the session. 18 of whom were interested but not ready. my decisions. How the teen wants people to treat him or her 5. 2 of whom had no surrogate. 100% attendance at all three sessions. To facilitate conversations and shared decision making between the adolescent and family about palliative care. the Five Wishes must be signed by their legal guardian. as well as finding solutions to any identified problem. Research assistant orients family to study and issues 2. The kind of medical treatment the teen wants 3. / Journal of Adolescent Health 54 (2014) 710e717 713 Table 1 Description of Family-Centered Advance Care Planning intervention [19] Session 1 Foundation Session 1 Goals Session 1 Process Lyon Family-Centered Advance Care Planning SurveyeAdolescent and Surrogate Versions. such as labeling feelings and concerns. Unique among living will and health agent forms. Adolescents’ worthwhile ratings increased over time from 65% for Session 1 (survey) to 71% for Session 2 (interview). Session 3 Foundation Session 3 Goals Session 3 Process The Five Wishes is a legal document that helps people express how they want to be treated if they are seriously ill and unable to speak for themselves. completeness for the 56 participants who completed the 3month follow-up. Comments from adolescents included: “I’m not use to talking about the dying part.” “It was a good session. To assess adolescents’ and surrogates’ values. How comfortable the teen wants to be 4. There were no statistically significant differences in baseline characteristics between study arms. spiritual and other beliefs.M. because they received no facilitated conversations. spiritual and other beliefs and goals with regard to death and dying 2.” “The Participant characteristics We approached 126 potential subjects. and life experiences with illness and EOL care 2. 1. including 72% of eligible families enrolled. 93% retention at 3-month post-intervention follow-up. and 10 of whom were ineligible. chaplain or their clergy). and spiritual. Surrogates are surveyed privately with regard to what they believe their adolescent prefers 4. Which person the teen wants to make health care decisions for him or her 2. complications Stage 2 explores adolescents’ philosophy regarding EOL decision making and their understanding of the facts Stage 3 reviews rationale for future medical decisions the adolescent would want the surrogate to understand or act upon Stage 4 uses the Statement of Treatment Preferences to describe clinical situations common to acquired immunodeficiency syndrome and related treatment choices Stage 5 summarizes the discussion or need for future discussions as situations or preferences change. values.. Research assistant highlights the similarities in their responses. Appropriate referrals are made to help resolve disagreements over decision making (e. To prepare the family to be able to fully represent the adolescent’s wishes Stage 1 assesses the adolescent’s understanding of current medical condition. Processes. To assess when to initiate EOL discussion and planning.” Comments from families included “I think this is very. 88%e 94% of adolescents found the intervention helpful. personal. prognosis.This session may include other family members or loved ones EOL ¼ end of life.g. which engage the participant in EOL questions 1. Adolescent is surveyed separately from the surrogate 3. I always want to know what my son thinks. emotional. 34 of whom declined. A similar analysis was not done in the control group.” “I think it just refocused . Participants were asked whether there was anything else they would like to add. and 100% data Satisfaction/worthwhile . We then randomized 30 dyads: 17 to FACE-TC and 13 to treatment as usual (Table 2). Results We evaluated and compared the Satisfaction Questionnaire [18] scores immediately after Sessions 1e3 between FACE-TC intervention adolescents and their families.E. providing an opportunity to express fears. A total of 31 dyads were screened for eligibility. What teen wants loved ones to know 6. I learned a lot about what to think aboutdgood thought process.g. it looks to all of a person’s needs: medical. Lyon et al. are facilitated.. for 16 adolescent/family dyads randomized to FACE-TC and 12 dyads randomized to treatment as usual. One adolescent did not complete the Spiritual Well-Being Scale of the Functional Assessment of Chronic Illness TherapyeVersion 4 Sp-EX. and to 82% for Session 3 (advance directive). a hospital ethicist or their doctor) or spiritual issues (e. building cohesion Session 2 Foundation Session 2 Goals Session 2 Process Respecting Choices Interview (Briggs and Hammes) 1. All intervention families rated each of the three sessions as worthwhile and universally found FACE-TC helpful (100%). very good and this is a way to bring up difficult topics to the table. Any spiritual or religious concerns teens may have For adolescents <age 18 years. one dyad failed screening because the teen did not know she had cancer. 1. 3 (7.2) 4. not shown in Table 5.0 22e62 12 (71) 5 (29) 6 (46) 7 (54) 18 (60) 12 (40) 1 (6) 16 (94) 1 (8) 12 (92) 2 (7) 28 (93) 1 (6) 7 (41) 9 (53) 1 (8) 6 (46) 6 (46) 2 (7) 13 (43) 15 (50) 0 0 1 (8) 6 (46) 6 (46) 0 1 13 15 1 (3) (43) (53) (3) 8 (62) 14 2 6 8 0 0 6 2 4 5 (35) (12) (24) (29) 14 (82) 1 (6) 2 (12) 0 0 2 (15) 3 (23) 10 (77) 1 (8) 2 (15) 0 7 (41) 9 (53) 1 (6) (47) (7) (20) (27) 24 (80) 2 (7) 4 (13) 0 1 1 10 5 (6) (6) (59) (29) 0 4 (31) 3 (23) 6 (46) 1 5 13 11 (3) (16) (43) (36) 2 1 6 5 3 (12) (6) (35) (29) (18) 2 1 0 9 1 4 2 6 14 4 (13) (7) (20) (47) (13) (15) (8) (69) (8) FACE ¼ Family-Centered Advance Care planning. The FACE-TC adolescents had a significantly lower depression score (b ¼ 5.9) to 94. Table 3 shows the means and SD and Table 5 lists the GEE results.8 (8.6) 6.2) 3.3 (5.4 46 36e62 42. Adolescents did not report significant differences in symptoms by group. Overall adolescents rated quality of communication with their providers very highly.4) 2.8 (10. 8.3 14 14e21 45.7) Higher scores represent higher symptom levels.2) 4.3) 5.4 (3. 9.8).649). School score evaluated by surrogate in the FACE-TC group improved significantly (b ¼ 15.4 (6. p ¼ . p ¼ .3 (8.5 16 14e21 16. SD ¼ standard deviation.2 þ 2.3) 5. timeeintervention interaction is not statistically significant [b ¼ 1. Quality of life There were no significant differences for adolescents in quality of life by group. questions asked were important questions [I] had not thought about and [I] can now discuss with [my] son.8) 5.0.9 (8.0 ¼ . the anxiety score dropped significantly (b ¼ 1.8 (5.9).0314) in the control group but increased in families in the intervention group (1. Table 4 reports mean scores and SD.0 14 14e20 16.1) 5. 0e126) Adolescent Surrogate’s own mood Beck Depression Inventory (range. nor were there significant differences over time.4 (4. Advance directive The FACE-TC adolescents completed the Five Wishes [31] advance directive with their families at a higher rate than .4 (SD.5 (8.4.5 (4. SOC: standard of care control.0268) at baseline and 3-month follow-up compared with controls. anxiety scores of adolescents dropped significantly (b ¼ 5.0 (5. The anxiety score of surrogates at 3-month follow-up dropped significantly Table 3 Descriptive statistics of psychological at the baseline and 3-month Post intervention Score Standard of care Family-Centered advance care planning control (N ¼ 13) for teens with cancer (N ¼ 17) Baseline 3 month Baseline 3 month Mean (SD) Mean (SD) Mean (SD) Mean (SD) Beck Anxiety Inventory (range.3 (SD.0287) compared with the control group. N (%) Male Female Race Asian Black White Declined Cancer diagnosis Leukemia Lymphoma Solid tumor Brain tumor Education In high school/no high school diploma High school grad/General Equivalency Diploma equivalent Some college/no bachelors College or higher education Income At or below federal poverty level 200% federal poverty level 300% federal poverty level >300% federal poverty line Unreported Family FACE SOC Total FACE SOC Total 16. Table 4 reports the mean scores and SD and Table 5 reports GEE results. That is. because the timeeintervention interaction is statistically significant (b ¼ 2. years Mean Mode Range Gender. with means ranging from 83. Tables 3 and 4 show the means and standard deviations (SD) and Table 5 displays the GEE results. p ¼ .039). controlling for baseline levels by intervention or time..8) 7.0) from baseline. Lyon et al.e. One control had just learned of a relapse before completing the baseline assessment and scored in the severe range. 0e63) Adolescent Surrogate’s own mood 6.9. p ¼ .” Anxiety and depression From baseline to 3-month follow-up. 15. p ¼ .0) 4.4. the time effect depends on intervention assignment.0 (3. / Journal of Adolescent Health 54 (2014) 710e717 Table 2 Baseline characteristics for adolescents with cancer (n ¼ 30) and their families (n ¼ 30) Characteristic Adolescent Age.9 46. With respect to change in the anxiety score of surrogates. p ¼ .7) 10. The patient was receiving psychological support and wanted to be in the study.714 M.3 (8.2.1) 5.E.6) 3.6 (2.6.1 38 22e56 43.0212) in both groups because time effect does not depend on intervention assignment (i. 1) (14.0 70.5 (16. Generalized increases in communication as the result of a pACP in-depth conversation merit further study.3 65.5 58. SD ¼ standard deviation. When asked. “When dying” (25%.1 82. whereas their teens did not.7 86. an underserved population who composed almost half of this sample. or all of the above (38%.9) 28.3) 77.8) 68.6 60. and safe.2) 89.3) Higher scores indicate better quality of life.4 (5.4 79. 66. controlled.7) (17. By whom? Trained or certified facilitators.9 60. adolescents’ experience of reflection on death and dying sustained high levels of peace and spirituality.8) (16. Future research should explore this phenomenon. n ¼ 4). and have the cognitive capacities necessary for an active role in decision making about their care [3e5.7 71.8) 25. Cure-directed care can be combined with pACP. because the time effect is statistically significant (b ¼ 2. p ¼ .0 85. Peace subscale scores of adolescents in the FACE-TC group were significantly higher (b ¼ 3.3) 74.9) (17.9) (19.35. and Functional Assessment of Chronic Illness TherapyeSpiritual WellBeing Scale. using highly structured conversations that adolescents with cancer and their families found feasible.6 (15.9 (13. intervention families were statistically more anxious than controls at 3-month post-intervention. n ¼ 3).9) (25.7) 70. suggesting to parents that their adolescents’ school quality of life had improved.5 (10.4) (23.1) (20.8) (17. This innovative model provided support in decision making about limiting burdensome medical interventions and completion of advance directives.4) 94.3) (16. p ¼ . Intervention families perceived improved school quality of life at follow-up.9) (11.8) 13. “Before getting sick” (19%.8) (14. Perhaps study communication generalized to the school domain. this study fills the gap in our knowledge about actual receipt of pACP by adolescents with cancer. Prognosis is not necessary.3 50. In contrast.4) 78. with 100% attendance at all three sessions.7 62.9 73.3) (27.8) (14. Intervention exposure appears to offer a protective effect regarding the general pattern of declining faith.5 91. Version 4 at baseline and 3-months post-intervention Quality of life Adolescent Total Physical School Emotional Social Surrogate perception of adolescent quality of life Total Physical School Emotional Social Quality of life: cancer symptom of adolescents Pain and hurt Nausea Procedural anxiety Treatment anxiety Worry Cognitive Perceived physical appearance Communication Quality of life: spirituality of adolescents Peace Faith Total score Family-Centered advance care planning for teens with cancer (N ¼ 17) Standard of care control (N ¼ 13) Baseline 3 month Baseline 3 month Mean (SD) Mean (SD) Mean (SD) Mean (SD) 71.1.9 57.4 (8. and Table 5 for GEE results). answering questions that have been persistent barriers to pACP: How? Evidence-based structured conversations with the adolescent and family.4) (29.8 (3.2 (4.4 (25. Low depressive symptom scores and high quality of life scores were maintained by adolescents in both groups.9) (13.7) (16. These findings confirm our HIV pilot results.3654]).4 86.7) (22.3 82. Where? Hospital based in-patient and outpatient settings.5 75.20.0296) at baseline and 3-month follow-up. This rise in anxiety is not surprising because the death of one’s child is one of life’s most stressful events [7].2 76. compared with controls.3 75.6 73. “When first hospitalized” (0%).7) (12.2) (17.0 67.9) (17.2.7 71.1 79.7 73.2 80.4 (4.3) 76.5) 68. but to an insignificant degree.0 70. adolescents with cancer were less satisfied with the FACE-TC intervention (ranging from 75% in Session 1%e82% in Session 3) than adolescents with HIV (ranging .6) (17. high retention at 3-month follow-up. When? From the onset of diagnosis. Family-Centered Advance Care Planning for Teens With Cancer demonstrated that participating in a pACP study alleviated adolescents’ anxiety significantly.2 (3. n ¼ 3). However.36].4) 78.8 (17.4) (16.0) (14.5 81.1) 24.8 (7.0466) and 715 the effect does not depend on intervention assignment (the timeeintervention interaction is not statistically significant [b ¼ 1.2) (19.2 69.6) (17.7) 75.5 (28.3) (20.2 (8.9 (13.7 70. Furthermore.6) 12.4 (11.2 55.0 91.5) 11. acceptable.0) 9.6 (3.0239) at baseline and at 3-month follow-up.9) 84.0) (15.4) (23.7) (12.3 84.0) 78. Although it had a small sample.4) (26.3 735.5) (22.0 (17.2 (4. but to clinically insignificant levels [13].8) (17.9 (4.9. yet increased families’ anxiety. 0%) and the advance directive documents were easily found in the medical record at 3-month postintervention. / Journal of Adolescent Health 54 (2014) 710e717 Table 4 Descriptive statistics of Pediatric Quality of Life Inventory: General and Cancer Symptom.1) 27.1 74.0 69. n ¼ 6).1 (18.8) 79.6 81. want to be involved in pACP decisions throughout the course of their illness.4) (25.25.9 65.0) (14.6) (17.M.2) (19.3) (20. Families especially valued the increased capacity to have EOL conversations with their children and to know what their child wanted.2 (14.5) 66.7) (13. “When do you think is the best time to bring up end-of-life decisions?” intervention adolescents responded. clinical trial of pACP for adolescents with cancer. p ¼ . these differences are clinically insignificant. which also found that pACP decreased adolescents’ anxiety.4) (22.2 76.4) (21.4) (15.9 87. Lyon et al.9) (21.6) (17.7 82.7 55.6 84.9) 74. Family-Centered Advance Care Planning for Teens With Cancer demonstrated acceptability to African-American adolescents with cancer and their families.8) (20.3 (15.1 72.8) (21.8 (30. with scores indicating minimal levels of anxiety.36].1 84.4) (19. As hypothesized.7 88. Contrary to the HIV pilot.6) 61.1 89.35.5) 83. Our findings also confirm that seriously ill adolescents understand treatment decisions [3e5. Only one adolescent reported ever talking to anyone about wishes for care at EOL before the study.2 77. and universal completion of advance directives. All treating oncologists received an electronic copy with a process note.5) (18. Spirituality Total score of adolescents in the FACE-TC group was significantly higher (b ¼ 8. “At diagnoses” (19%.9) 67.3 75. p ¼ .9 88.19.9 70.E. Discussion This is the first randomized. Faith subscale scores of adolescents at 3-month followup dropped significantly from baseline in both groups.9) (29.7 (22.7) (11.7) (25. standard of care (100% vs.4 (15.2) (23.9) (20.5 72.2 91. compared with controls (see Table 3 for means and SD.6 76.8) (17.0) (19.0 (18. 100% of intervention families rated each session as worthwhile.3) (10.8 88. 4 2.0 (.5389) The Generalized Estimating Equation results of scores about quality of life for cancer symptoms of adolescents are not included because both time and intervention did not have significant statistical effects. depressed individuals should not participate in ACP because of the likelihood of impaired decision making (e.0466)* 3.4380) 1. b Intervention was coded as 0 ¼ standard of care control and 1 ¼ Family-Centered Advance Care Planning Intervention. Sustainability of FACE-TC is unknown and the study was not blinded.0392)* 10.9 3.1594) (.1 (.0001) 1. Kathleen .9731) (. Cynthia Brawner-Jackson. Families ready to discuss pACP agreed to participate. The control arm may also have caused bias in the other direction by bringing up the topic of pACP.4 (. Although the sample size was small.4 (. which is often not addressed. almost three fourths of eligible dyads approached participated.4 (.0642) 1. although participants represent an ethnically diverse group in an urban children’s hospital.6228) 2.0212)* 1.3 75. (5) oncologists received e-mail communication about the process and pACP documents.4889) (.1 (.8445) (.6 76.5586) (. There was no active control group for time and attention.2 (.6 6. Joy Lere.5007) 98.6132) (.9 1.8 6. a higher rate than in comparable adult studies. suicidality).2 (. it was large compared with other pACP studies. and Brittney Lee.0239)* 1.0609) 5.716 M. Restriction of range in depression scores at recruitment may have decreased the chance of finding significant differences between groups. Lyon et al.6490) 2.8 (.0001) 3. and benefited from being a randomized clinical trial with an intent-to-treat design.0001) 3.9 (. so the discussion was not hypothetical.7339) (.0630) 3.3 (.3614) 3.0002) 4.2 (.0001) (<. The authors extend their gratitude to the research assistants who worked with the families: Jessica Gaines. Differences may have arisen because adolescents in the FACE-HIV study were medically stable outpatients. These findings may not generalize beyond this study site. whereas many adolescents in the FACE-TC study were not.0001) 5.3 3.5 (.7 7.1552) 61.1 9.8037) .0287)* (. / Journal of Adolescent Health 54 (2014) 710e717 Table 5 Selected results of Generalized Estimating Equation model Outcome Psychological score Beck Anxiety Inventory Adolescent Surrogate’s own mood Beck Depression InventoryeII Adolescent Surrogate’s own mood Quality of life Adolescent Total Physical School Emotional Social Surrogate perception of adolescent’s quality of life Total Physical School Emotional Social Quality of life: spirituality of adolescents Peace subscale Faith subscale Total Main effect of Timea (p value) Main effect of Interventionb (p value) 9.0001) (<.0001) (<.8 . (2) the patient and family/surrogate decision maker were present.5 (<.0001) (<.9643) (. from 92% to 100%) [18].2 7.0 (.6 (. randomized.8 (<. * p < .3286) 8. Fully powered.3249) (.2 (.0001) (<.9 (. and (6) advance directives were readily available in the medical record.1 (.1 82. disease-specific protocol to be developmentally appropriate and culturally sensitive.8 2. Jessica Greenberg. Adolescents with cancer recognized pACP as a process. a Time was coded as 0 ¼ baseline and 1 ¼ 3-month post-intervention follow-up.2435) (.3 9.0001) 70. which created sample selection bias.2 10.8424) 3. which confirms earlier findings with adolescents [3.1085) (.3 9.g.5375) 5.3654) 3.0 (.E.1007) .6373) (. so adolescents who prefer to have their doctor or their families make decisions for them do so. However. Acknowledgments In addition to the co-authors.8741) (.6973) 1.2 (. This study moves the field of pACP forward. longitudinal.05. (3) conversations first addressed adolescents’ values and goals of care before discussing treatment preferences.7 13. These findings should inform research directions and clinical care for teens with cancer and other serious illnesses.5 3.2741) (.8 (<.8 (. blinded studies are needed. (4) trained or certified facilitators conducted these conversations.2 (.0 (.8464) Intercept (p value) 24.2 (.0001) 5. which may have magnified differences. controlled trial is needed. implementing structured conversations in practice.6 (. which potentially created bias.0 69. especially Jessica Gaines and her mother. The authors thank their families for participation and the community for help in developing this protocol.6043) (.1 7.3674) (.0268)* . They thank their consultants.3 (.3 4..0001) (<. especially in children <18 years of age.0001) (<.2475) (. multisite. the following individuals contributed significantly to this work.0341)* 3.1123) (.28] and supports the American Academy of Pediatrics recommendation of the concurrent use of PC and curative care for children from the time of diagnosis of a life-threatening illness [37].9 (.0 4.9 (. the intention of pACP is to individualize the process.6 .5 58.4087) (.0296)* Interaction between time and intervention (p value) 1.8 (<. Enrolling sick adolescents in an active control group was judged to be too burdensome.7 2. with 75% preferring to discuss pACP early or throughout the illness trajectory.5179) (.3542) .0830) 1.3 1.9 (<.7 55.3784) (.3 50.3912) 7.9 3. Furthermore.0 15. A larger.4 (<. Nevertheless.5193) (.0 (. They thank Saeid Goudarzi for help with data management and Annie Fulton for help with creating Teleforms.0001) 11. The authors thank Jennie Perez for help with institutional review board submissions and modifications.0001) (<.8 (.7472) (.7 62. Safeguards [38] were put in place that represent effective ACP: (1) an iterative process of adapting a structured. Pediatric Academic Societies Annual Meeting. Pediatr Clin North Am 2007. An exploratory survey of end-of-life attitudes. Jacobs S. [37] American Academy of Pediatrics. J Adolesc Health 2004. April 30. Burwinkle TM. West J Nurs Res 2007.2:27. Supplementary Data Supplementary data related to this article can be found at http://dx. Table 9. Keenan HT. . Sheetz J. The competency of children and adolescents to make informed treatment decisions. Blumenthal J.27:595e600. Bethesda.60: 946e50. JAMA Pediatr 2013.” Society of Adolescent Health and Medicine Meeting. Greer JA. National Institute of Nursing Research/National Institutes of Health. on May 9 and 11. 2012. Pediatrics 2007. References [1] Feudtner C. 2006. JAMA 1995. trust. Silvester W. 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