Cancer worry and empathy moderate the effect of a survivorship-focused intervention on quality of life.

OBJECTIVE: This study examined the impact of a survivorship planning consultation (SPC) for patients with Hodgkin's lymphoma and diffuses large B-cell lymphoma on quality of life (QOL). We specifically assessed two potential moderators, cancer worry and perceived empathy, of the intervention effects on QOL. METHODS: This cluster randomized, four-site trial examined the efficacy of a SPC; physicians received communication skills training and applied these skills in a survivorship-focused office visit using a care plan vs a control arm in which physicians were trained to and subsequently provided a time-controlled, manualized wellness rehabilitation consultation focused only on discussion of healthy nutrition and exercise. We examined the effect of the intervention on patients' QOL and examined potential moderators-cancer worry and perceived physician empathy. RESULTS: Forty-two physicians and 198 patients participated. There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10). However, cancer worry was a significant moderator of the effects of the intervention on three QOL domains (physical P = .04; social P = .04; spiritual P = .01) and perceived empathy was a significant moderator of QOL (physical P = .004; psychological P = .04; social P = .01). Specifically, the beneficial effects of the intervention were more pronounced among patients who initially reported higher levels of cancer worry and lower levels of physician empathy. CONCLUSIONS: This study identified two factors, perceived empathy and cancer worry, that were found to impact the QOL of patients who participated in this communication-based survivorship intervention.

Patient Spirituality as a Component of Supportive Care: Assessment and Intervention.

OPINION STATEMENT: National supportive care guidelines for patients with cancer include recognition of patients' spirituality and spiritual needs. Experts differ on how best to address this dimension to our patients' lives. Some suggest that patients' medical team should take on spiritual care, and others suggest referral to chaplains or collaboration with outside clergy. In our view, the patient's medical team ought to best acknowledge patient spirituality when so desired by the patient, but intervention in the case of serious spiritual crisis ought to be the responsibility of those with specific training in this realm. For some patients, "concordance" between the specific spiritual tradition of the patient and chaplain is necessary where for others, non-denominational, secular, or inter-faith chaplaincy services are welcome. The central role for physicians and nurses in this area, is listening, awareness, respect, and where necessary, referral.

Efficacy of a survivorship-focused consultation versus a time-controlled rehabilitation consultation in patients with lymphoma: A cluster randomized controlled trial.

BACKGROUND: Survivors of cancer often describe a sense of abandonment after treatment along with heightened uncertainty and limited knowledge of what lies ahead. This study examined the efficacy of a survivorship care plan (SCP) intervention to help physicians to address survivorship issues through communication skills training plus a new consultation focused on the use of an SCP for patients with Hodgkin lymphoma and diffuse large B-cell lymphoma. METHODS: This 4-site cluster randomized trial examined the efficacy of a survivorship planning consultation (SPC) in patients who achieved complete remission after the completion of first-line therapy (for the SPC, physicians received communication skills training and, using an SCP, applied those skills in a survivorship-focused office visit) versus a control arm in which physicians were trained in and subsequently provided a time-controlled, manualized wellness rehabilitation consultation (WRC) focused only on discussion of healthy nutrition and exercise as rehabilitation after chemotherapy. The primary outcomes for patients were changes in knowledge about lymphoma and adherence to physicians' recommendations for vaccinations and cancer screenings. RESULTS: Forty-two physicians and 198 patients participated across the 4 sites. Patients whose physicians were in the SPC arm had greater knowledge about their lymphoma (P = .01) and showed greater adherence to physician recommendations for influenza vaccinations (P = .02) and colonoscopy (P = .02) than patients whose physicians were in the WRC arm. CONCLUSIONS: A dedicated consultation using an SCP and supported by communication skills training may enhance patients' knowledge and adherence to some health promotion recommendations.

Patient and caregiver characteristics related to completion of advance directives in terminally ill patients.

OBJECTIVE: There is a growing body of literature describing the characteristics of patients who plan for the end of life, but little research has examined how caregivers influence patients' advance care planning (ACP). The purpose of this study was to examine how patient and caregiver characteristics are associated with advance directive (AD) completion among patients diagnosed with a terminal illness. We defined AD completion as having completed a living will and/or identified a healthcare power of attorney. METHOD: A convenience sample of 206 caregiver-patient dyads was included in the study. All patients were diagnosed with an advanced life-limiting illness. Trained research nurses administered surveys to collect information on patient and caregiver demographics (i.e., age, sex, race, education, marital status, and individual annual income) and patients' diagnoses and completion of AD. Multivariate logistic regression was employed to model predictors for patients' AD completion. RESULTS: Over half of our patient sample (59%) completed an AD. Patients who were older, diagnosed with amyotrophic lateral sclerosis, and with a caregiver who was Caucasian or declined to report an income level were more likely to have an AD in place. SIGNIFICANCE OF RESULTS: Our results suggest that both patient and caregiver characteristics may influence patients' decisions to complete an AD at the end of life. When possible, caregivers should be included in advance care planning for patients who are terminally ill.

Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent.

BACKGROUND: Participants in early-phase clinical trials have reported high expectations of benefit from their participation. There is concern that participants misunderstand the trials to which they have consented, which is based on assumptions about what patients mean when responding to questions about likelihood of benefit. METHODS: Participants were 27 women and 18 men in early-phase oncology trials at 2 academic medical centers in the United States. To determine whether expectations of benefit differ depending on how patients are queried, the authors randomly assigned participants to 1 of 3 interviews corresponding to 3 questions about likelihood of benefit: frequency type, belief type, and vague. In semistructured interviews, participants were queried about how they understood and answered the question. Participants then answered and discussed 1 of the other questions. RESULTS: Expectations of benefit in response to the belief-type question were significantly greater than expectations in response to the frequency-type and vague questions (P=0:02). The most common justifications involved positive attitude (n=27 [60%]) and references to physical health (n=23 [51%]). References to positive attitude were most common among participants with higher (> 70%) expectations (n = 11 [85%]) and least common among those with lower ( < 50%) expectations (n = 3 [27%]). CONCLUSIONS: The wording of questions about likelihood of benefit shapes the expectations that patients express. Patients who express high expectations may not do so to communicate understanding but rather to register optimism. Ongoing research will clarify the meaning of high expectations and examine methods for assessing understanding.

Family health care decision making and self-efficacy with patients with ALS at the end of life.

OBJECTIVE: Persons with ALS differ from those with other terminal illnesses in that they commonly retain capacity for decision making close to death. The role patients would opt to have their families play in decision making at the end of life may therefore be unique. This study compared the preferences of patients with ALS for involving family in health care decisions at the end of life with the actual involvement reported by the family after death. METHODS: A descriptive correlational design with 16 patient-family member dyads was used. Quantitative findings were enriched with in-depth interviews of a subset of five family members following the patient's death. RESULTS: Eighty-seven percent of patients had issued an advance directive. Patients who would opt to make health care decisions independently (i.e., according to the patient's preferences alone) were most likely to have their families report that decisions were made in the style that the patient preferred. Those who preferred shared decision making with family or decision making that relied upon the family were more likely to have their families report that decisions were made in a style that was more independent than preferred. When interviewed in depth, some family members described shared decision making although they had reported on the survey that the patient made independent decisions. SIGNIFICANCE OF RESULTS: The structure of advance directives may suggest to families that independent decision making is the ideal, causing them to avoid or underreport shared decision making. Fear of family recriminations may also cause family members to avoid or underreport shared decision making. Findings from this study might be used to guide clinicians in their discussions of treatments and health care decision making with persons with ALS and their families.

On the disenchantment of medicine: Abraham Joshua Heschel's 1964 address to the American Medical Association.

In 1964, the American Medical Association invited liberal theologian Abraham Joshua Heschel (1907-1972) to address its annual meeting in a program entitled "The Patient as a Person" [1]. Unsurprisingly, in light of Heschel's reputation for outspokenness, he launched a jeremiad against physicians, claiming: "The admiration for medical science is increasing, the respect for its practitioners is decreasing. The depreciation of the image of the doctor is bound to disseminate disenchantment and to affect the state of medicine itself" [1, p. 35]. Heschel's reference to "disenchantment" suggests that he may have been familiar with the work, or at least the outlook, of sociologist Max Weber, whose 1917 address "Science as a Vocation" portrays the modern world as disenchanted by the progress of rationalism. Heschel's life's vocation had been to uncover the inner meaning of religious faith and to translate that faith into principled action. Heschel saw disenchantment not as an inescapable aspect of modern life but rather as the byproduct of physicians' conscious choices to seek worldly success and material comfort. Yet, because of their privileged position as witnesses to human vulnerability, physicians possess an obligation to develop their own personhood, to re-enchant medicine, and through medicine to spark a positive transformation in all of modern life. As Heschel says, "The doctor must realize the supreme nobility of his vocation, to cultivate a taste for the pleasures of the soul. … The doctor is a major source of moral energy affecting the spiritual texture and substance of the entire society" [1, pp. 34, 38]. While Heschel's conception of the physician's role is romanticized and idealized, changes in the organization and practice of medicine have validated his concerns.

Spiritual Needs and Perception of Quality of Care and Satisfaction With Care in Hematology/Medical Oncology Patients: A Multicultural Assessment.

CONTEXT: Assessment and response to patients' spiritual concerns are crucial components of high-quality supportive care. Better measures of spiritual needs across the cultural spectrum may help direct necessary interventions. OBJECTIVES: The objective of this study was to assess spiritual needs in a racially/ethnically and religiously mixed sample of hematology and oncology outpatients and examine the association between spiritual needs and perception of quality of care and satisfaction with care. METHODS: This is an observational study of 727 racially/ethnically and religiously diverse outpatients. Spiritual needs were measured using a validated, 23-item questionnaire, the Spiritual Needs Assessment for Patients. Scales were administered in four languages. RESULTS: Forty-four percent were white, 13% Hispanic, 25% black, and 14% Asian. English was the primary language for 57%; 59% considered themselves "spiritual but not religious." At least one spiritual need was reported by 79%. Forty-eight percent were comfortable having their physician inquire about spiritual needs. Compared with English-speaking patients, Russian-speaking patients reported lower spiritual needs (P = 0.003). Patients who considered themselves "spiritual but not religious" (P = 0.006) reported a higher level of spiritual needs. Higher spiritual needs were associated with less satisfaction with care (P = 0.018) and lower perception of quality of care (P = 0.002). CONCLUSION: Spiritual needs are common in an ethnically, religiously, and linguistically diverse cancer patient population but may differ by cultural background. High levels of spiritual need are associated with lower levels of satisfaction and diminished perception of quality of care. Training clinicians to address patients' spiritual concerns, with attention to cultural differences, may improve patients' experiences of care.

The Trial of Ascertaining Individual Preferences for Loved Ones' Role in End-of-Life Decisions (TAILORED) Study: A Randomized Controlled Trial to Improve Surrogate Decision Making.

CONTEXT: Patients with terminal illnesses often require surrogate decision makers. Prior research has demonstrated high surrogate stress, and that despite standards promoting substituted judgment, most patients do not want their surrogates to make pure substituted judgments for them. It is not known how best to help loved ones fulfill the surrogate role. OBJECTIVES: To test the effectiveness of an intervention to help surrogate decision makers. METHODS: One hundred sixty-six patients (41% with amyotrophic lateral sclerosis and 59% with gastrointestinal cancers) and their surrogates at two university medical centers were randomized to an intensive nurse-directed discussion of the end-of-life decision control preferences of the patient (TAILORED) or a discussion of nutrition (CONTROL); 163 completed baseline interviews and underwent the intervention. RESULTS: Twelve patients died during follow-up and 137 dyads completed the study. Post-intervention, using all available data, TAILORED patients and surrogates became more likely to endorse mutual surrogate decision making, that is, a balance of their own wishes and what the surrogate thinks best (adjusted odds compared with baseline for patients = 1.78, P = 0.04; adjusted odds for surrogates = 2.05, P = 0.03). CONTROL patients became 40% less likely to endorse mutual surrogate decision making (P = 0.08), and CONTROL surrogates did not change significantly from baseline (adjusted odds = 1.44, P = 0.28). Stress levels decreased for TAILORED surrogates (impact of events scale = 23.1 ± 14.6 baseline, 20.8 ± 15.3 f/u, P = 0.046), but not for CONTROL (P = 0.85), and post-intervention stress was lower for TAILORED than CONTROL (P = 0.04). Surrogates' confidence was uniformly high at baseline and did not change. Caregiver burden (Zarit) increased from 12.5 ± 6.5 to 14.7 ± 8.1 for TAILORED (P < 0.01), while not changing for CONTROL, yet satisfaction with involvement in decision making was higher at follow-up for TAILORED than for CONTROL (71% vs. 52%, P = 0.03). CONCLUSION: TAILORED patients and surrogates who completed the study adopted a more mutual decision-making style, balancing their own wishes with what the surrogate thinks would be best for them. Surrogates reported less stress and more satisfaction. Confidence was high at baseline and did not change. There was a modest increase in caregiver burden. These findings suggest that interventions like TAILORED might positively impact surrogate decision making.

Protocol for a cluster randomised trial of a communication skills intervention for physicians to facilitate survivorship transition in patients with lymphoma.

INTRODUCTION: Survivors of cancer often describe a sense of abandonment post-treatment, with heightened worry, uncertainty, fear of recurrence and limited understanding of what lies ahead. This study examines the efficacy of a communication skills training (CST) intervention to help physicians address survivorship issues and introduce a new consultation focused on the use of a survivorship care plan for patients with Hodgkin's lymphoma and diffuse large B-cell lymphoma. METHODS AND ANALYSIS: Specifically, this randomised, 4-site trial will test the efficacy of a survivorship planning consultation (physicians receive CST and apply these skills in a new survivorship-focused office visit using a survivorship plan) with patients who have achieved complete remission after completion of first-line therapy versus a control arm in which physicians are trained to subsequently provide a time-controlled, manualised wellness rehabilitation consultation focused only on discussion of healthy nutrition and exercise as rehabilitation postchemotherapy. The primary outcome for physicians will be uptake and usage of communication skills and maintenance of these skills over time. The primary outcome for patients is changes in knowledge about lymphoma and adherence to physicians' recommendations (eg, pneumococcus and influenza vaccinations); secondary outcomes will include perceptions of the doctor-patient relationship, decreased levels of cancer worry and depression, quality of life changes, satisfaction with care and usage of healthcare. This study will also examine the moderators and mediators of change within our theoretical model derived from Leventhal's Common-Sense Model of health beliefs. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Boards at Memorial Sloan Kettering Cancer Centers and all other participating sites. This work is funded by the National Cancer Institute (R01 CA 151899 awarded to DWK and SH as coprincipal investigators). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute (NCI) or the National Institutes of Health (NIH). The study findings will be disseminated to the research and medical communities through publication in peer-reviewed journals and through presentations at local, national and international conferences. TRIAL REGISTRATION NUMBER: NCT01483664.

When patients lack capacity: the roles that patients with terminal diagnoses would choose for their physicians and loved ones in making medical decisions.

Current approaches to end-of-life decision making are widely considered inadequate. We explored these complexities by examining how patients with terminal diagnoses would choose to involve their physicians and loved ones in making medical decisions, assuming they were able and unable to participate. Cross-sectional interviews of 130 patients recently diagnosed with fatal conditions were conducted. Patients were recruited from two academic medical centers using a modification of the Decision Control Preferences Scale, ranging from independent decision making to decision making that relies upon others. Patients were asked how they would balance their own wishes relative to the input of physician and loved ones in making medical decisions, and to weigh the input of loved ones relative to physician. Most patients (52%), assuming they had the capacity, would opt to share decision making with their physicians, but 15% would defer to their physicians and 34% would make decisions independently. Similarly, 44% would share decision making with their loved ones, but fewer (6%) would defer to their loved ones. Thirty-nine percent would rely upon their physicians' judgments about what would be best for them rather than their own wishes if they became unconscious, compared with 15% who would do so if they were conscious (P < 0.001). Nonetheless, patients were more likely to weigh their loved ones' input more heavily than their physicians' input if they were unconscious (33%) than if they were conscious (7%, P = 0.05). Race, religion, gender, diagnosis, and health status were largely unassociated with patients' decision control preferences. Patients with terminal diagnoses report a wide diversity of decision control preferences, but most would opt to share decision making with their physicians and loved ones. If unable to decide for themselves, they shift toward greater reliance on physician input relative to their own wishes but would weigh loved ones' input more heavily than physician input. Deciding for patients who cannot speak for themselves may be more complex than has previously been reflected in law, policy, or clinical ethics.

Pegylated liposomal doxorubicin replacing conventional doxorubicin in standard R-CHOP chemotherapy for elderly patients with diffuse large B-cell lymphoma: an open label, single arm, phase II trial.

BACKGROUND: The present multicenter phase II trial evaluated the safety and efficacy of pegylated liposomal doxorubicin (PLD) instead of conventional doxorubicin in standard R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine [Oncovin], and prednisone) therapy for elderly patients with diffuse large B-cell lymphoma. MATERIALS AND METHODS: Patients aged > 60 years who had stage II to IV disease were included. Treatment consisted of rituximab 375 mg/m(2) intravenously (I.V.); cyclophosphamide 750 mg/m(2) IV; PLD 40 mg/m(2) (maximum, 90 mg) I.V. over 1 hour; and vincristine 2.0 mg I.V., all on day 1. Additionally prednisone, 40 mg/m(2), was given orally on days 1 to 1 to 5 (DRCOP [rituximab, cyclophosphamide, PLD, vincristine, and prednisone]). The cycles were repeated every 3 weeks for 6 to 8 cycles. RESULTS: Eighty patients were enrolled and were evaluable for toxicity. The median age was 69 years. All except 1 had additional cardiac risk factors for anthracycline-induced cardiac toxicity beyond advanced age. From the intent-to-treat analysis of 79 eligible patients, the overall response rate was 86%, and the complete response rate was 78%. Cardiac events greater than grade 3 were identified in 3 patients (4%); grade 1 to 2 events, mostly asymptomatic declines in ejection fraction, were noted in another 16 patients. One death was attributed to cardiac failure. The estimated 5-year event-free and overall survival rate was 52% and 70%, respectively. CONCLUSION: DRCOP represents an effective strategy for potentially mitigating cardiotoxicity in elderly patients with aggressive B-cell lymphoma. Future studies incorporating baseline cardiac risk assessments, long-term follow-up data, and biospecimen collection for correlative science should be undertaken.

A Chinese version of the Spiritual Needs Assessment for patients survey instrument.

CONTEXT: Unmet spiritual needs have been associated with decreased patient ratings of quality of care, satisfaction, and quality of life. Few instruments exist to measure spiritual needs particularly among non-English speaking patients in the U.S. OBJECTIVE: To develop an internally consistent and reliable Chinese version of the Spiritual Needs Assessment for Patients (SNAP). METHODS: The SNAP consists of 23 total items in 3 domains: psychosocial (n=5), spiritual (n=13), and religious (n=5). The Chinese SNAP was developed through a translation-back translation process followed by cognitive pre-testing. The instrument was then administered to a convenience sample of 30 ambulatory predominantly Mandarin speaking cancer patients in New York. We tested for internal consistency, test-retest reliability, and degree of association with the question "Have your spiritual needs been met?" RESULTS: Mean participant age was 56 years, 70% had less than a high school education. Twenty three percent were Buddhist, 63% identified no religious affiliation, 83% described themselves as spiritual but not religious, 33% reported unmet spiritual needs, and 60% wanted help meeting their spiritual needs. The Cronbach's alpha for the total SNAP was 0.89. Test-retest correlation coefficient for the total SNAP=0.75. Unmet spiritual needs, as assessed through a single-item question, were not associated with higher SNAP scores in contrast to results of the English SNAP. CONCLUSION: The Chinese SNAP is an internally consistent and reliable instrument for measuring spiritual needs. The apparent lack of correlation between the SNAP score and the question on unmet spiritual needs may suggest that the SNAP captures patient needs considered by Westerners to be spiritual but that Chinese patients might not readily describe as spiritual.

The Spiritual Needs Assessment for Patients (SNAP): development and validation of a comprehensive instrument to assess unmet spiritual needs.

CONTEXT: Unmet spiritual needs have been associated with decreased patient ratings of quality of care, satisfaction, and quality of life. There is a need for a well-validated, psychometrically sound instrument to describe and measure spiritual needs. OBJECTIVES: To develop a valid and reliable instrument to assess patients' spiritual needs. METHODS: Instrument development was based on a literature review, clinical and pastoral evaluation, and cognitive pretesting (n=15 ambulatory cancer patients). Forty-seven ambulatory cancer patients completed cross-sectional and longitudinal surveys to test instrument validity and reliability. Internal reliability was assessed by Cronbach's α, test-retest reliability by Spearman's correlation coefficients, and construct validity by comparing instrument scores to a previously used single-item spiritual needs question. RESULTS: The Spiritual Needs Assessment for Patients (SNAP) comprises a total of 23 items in three domains: psychosocial (n=5), spiritual (n=13), and religious (n=5). Sixty percent of participants were white, 21% black, 13% Hispanic, and 6% Asian or other. Fifty-eight percent were Catholic, 13% Jewish, 11% Protestant, 2% Buddhist, 2% Muslim, and 2% Hindu. Sixty-eight percent described themselves as spiritual but not religious; 15% reported unmet spiritual needs; 19% wanted help meeting their spiritual needs. Cronbach's α for the total SNAP was 0.95, and for the subscales was psychosocial=0.74, spiritual=0.93, and religious needs=0.86. Test-retest correlation coefficients were total SNAP=0.69, psychosocial needs=0.51, spiritual needs=0.70, and religious needs=0.65. Participants reporting unmet spiritual needs had significantly higher mean scores on the total SNAP (66.3 vs. 49.4, P=0.03) and on the spiritual needs subscale (39.0 vs. 28.3, P=0.02). CONCLUSION: The results provide preliminary evidence that the SNAP is a valid and reliable instrument for measuring spiritual needs in a diverse patient population.

Research participants' high expectations of benefit in early-phase oncology trials: are we asking the right question?

PURPOSE: To determine whether patients' expectations of benefit in early-phase oncology trials depend on how patients are queried and to explore whether expectations are associated with patient characteristics. PATIENTS AND METHODS: Participants were 171 patients in phase I or II oncology trials in the United States. After providing informed consent for a trial but before receiving the investigational therapy, participants answered questions about expectations of benefit. We randomly assigned participants to one of three groups corresponding to three queries about expectations: frequency type, belief type, or both. Main outcomes were differences in expectations by question type and the extent to which expectations were associated with demographic characteristics, numeracy, dispositional optimism, religiousness/spirituality, understanding of research, and other measures. RESULTS: The belief-type group had a higher mean expectation of benefit (64.4 of 100) than the combination group (51.6; P = .01) and the frequency-type group (43.1; P < .001). Mean expectations in the combination and frequency groups were not significantly different (P = .06). Belief-type expectations were associated with a preference for nonquantitative information (r = -0.19; 95% CI, -0.19 to -0.36), knowledge about research (r = -0.21; 95% CI, -0.38 to -0.03), dispositional optimism (r = 0.20; 95% CI, 0.01 to 0.37), and spirituality (r = 0.22; 95% CI, 0.03 to 0.38). Frequency-type expectations were associated with knowledge about clinical research (r = -0.27; 95% CI, -0.27 to -0.51). CONCLUSION: In early-phase oncology trials, patients' reported expectations of benefit differed according to how patients were queried and were associated with patient characteristics. These findings have implications for how informed consent is obtained and assessed.