Placebo and nocebo effects in randomized double-blind clinical trials for fatigue in advanced cancer patients

9640 Background: We have previously reported significant placebo response in randomized controlled treatment trials for cancer related fatigue (CRF). We conducted a retrospective study to determine the frequency and predictors of response to placebo and nocebo effect in patients with CRF. Methods: We reviewed patients that received placebo in two previous randomized clinical trials conducted by our group and determined the proportion of patients who demonstrated clinical response to fatigue using an increase (ΔFACIT-F score) > 7 from baseline to day 8, and those with nocebo response as those who reported side effects. Baseline patient characteristics and symptoms recorded from the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects. Results: A total of 105 advanced cancer patients received placebo. 59 (56%) patients responded to placebo (median Δ FACIT-F score of 22). Worse baseline anxiety and well-being subscale score (univariate) and well-being (multivariate, MR) were significantly associated with placebo response. Common side effects reported were insomnia (79%), anorexia (53%), nausea (38%) and restlessness (34%). MR analysis showed that worse baseline (ESAS) sleep, appetite, nausea, and restless are associated with increased reporting of these side effects ( Table ). Conclusions: Nearly half of advanced cancer patients enrolled in the fatigue trials responded to placebo. Worse physical well-being score was associated with placebo response. Patients experiencing specific symptoms at baseline were more likely to report these as side effects of the medication. These findings should be considered in fatigue clinical trial design. [Table: see text] No significant financial relationships to disclose.

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Individual Meaning-Centered Psychotherapy for Advanced Cancer Patients

10.1093/med/9780199837229.003.0003 ◽

2017 ◽

Author(s):

William Breitbart ◽

Wendy G. Lichtenthal ◽

Allison J. Applebaum ◽

Melissa Masterson

Keyword(s):

Clinical Trials ◽

End Of Life ◽

Cancer Patients ◽

Advanced Cancer ◽

Therapeutic Intervention ◽

Well Being ◽

Existential Psychology ◽

Advanced Cancer Patients ◽

Spiritual Well Being ◽

Existential Concerns

Among the advanced cancer population, existential concerns are major issues that promote significant distress. For patients who are facing death, meaning and the preservation of meaning are not only clinically and existentially important but also central concepts to a therapeutic intervention. Based on Viktor Frankl’s logotherapy and the principles of existential psychology and philosophy, “meaning-centered psychotherapy” was developed to help patients with advanced cancer sustain or enhance a sense of meaning, peace, and purpose in their lives. This chapter provides an overview of work developing and testing individual meaning-centered psychotherapy (IMCP). It provides an overview of the session content in the IMCP intervention. It also presents findings from clinical trials, which support the efficacy of IMCP as an intervention to increase a sense of meaning, spiritual well-being, and hope while decreasing end-of-life despair. Furthermore, it presents difficult scenarios that may arise when delivering IMCP for clinicians interested in this work.

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Impact of an outpatient interdisciplinary team (IDT) consultation on symptom clusters in advanced cancer patients seen at a supportive care outpatient clinic (OSC) in a tertiary cancer center

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e20542 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e20542-e20542

Author(s):

S. Yennurajalingam ◽

D. L. Urbauer ◽

R. Chacko ◽

D. Hui ◽

Y. A. Amin ◽

...

Keyword(s):

Cancer Patients ◽

Advanced Cancer ◽

Interdisciplinary Team ◽

Well Being ◽

Symptom Clusters ◽

Advanced Cancer Patients ◽

Edmonton Symptom Assessment Scale ◽

Cluster Composition ◽

The Impact

e20542 Background: Advanced cancer patients develop severe physical and psychosocial symptom clusters. There is limited data on the impact of an outpatient interdisciplinary team (IDT) consultation lead by palliative care specialists on symptom clusters. Cluster composition and consistence, response rate and predictors of response are unknown. Methods: 914 consecutive patients with advanced cancer presenting in the OSC from Jan 2003 to Oct 2008 with a complete Edmonton symptom assessment scale at the initial and follow-up visit (median 14 days, range 1–4 wks), and CAGE status (alcohol screening) were reviewed. Wilcoxon ranked sign test was used to determine whether symptoms changed over time. Principal components factor analysis with varimax rotation was used to determine clusters of symptoms at baseline and at follow-up. The number of factors calculated was determined based upon the number of eigen values that were greater than one. Results: Median age was 59 yrs, female were 46%. The most common primary cancer was Lung (19%). Baseline and follow-up visit scores (mean, SD) were: fatigue 5.7 (2.1) and 5.2 (2.2, p<0.0001), pain 4.9 (2.6) and 4.1 (2.6 p<0.0001), nausea 1.8 (2.4) and 1.7 (2.3, p=0.1), depression 2.6 (2.5) and 2.2(2.4,p<0.0001), anxiety 2.9 (2.7) and 2.4 (2.4, p<0.0001), drowsiness 3.2 (2.8) and 3.2 (2.6, p=0.7), dyspnea 2.6 (2.7) and 2.4 (2.6), p=0.0027), appetite 4.2(2.7) and 3.9 (2.7, p<0.0001), sleep 4.2 (2.6) and 3.8 (2.6, p<0.0001) and well being 4.3 (2.5) and 3.9 (2.3, p<0.0001). During the follow- up the symptom clusters varied from a 3 factor to a 2 factor model, reflecting the impact of the IDT on symptom burden. CAGE positive and CAGE negative patients had a significantly different symptom cluster model. Conclusions: Cluster composition differs when patients are assessed and managed by an IDT and among patients who screen positive for alcoholism. [Table: see text] No significant financial relationships to disclose.

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Differences in performance status assessments between palliative care specialists, nurses, and oncologists.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.31_suppl.19 ◽

2014 ◽

Vol 32 (31_suppl) ◽

pp. 19-19

Author(s):

YuJung Kim ◽

Yi Zhang ◽

Ji Chan Park ◽

David Hui ◽

Gary B. Chisholm ◽

...

Keyword(s):

Palliative Care ◽

Cancer Patients ◽

Advanced Cancer ◽

Performance Status ◽

Well Being ◽

Assessment Tools ◽

Advanced Cancer Patients ◽

Care Clinic ◽

Edmonton Symptom Assessment Scale ◽

Ecog Ps

19 Background: The Eastern Cooperative Oncology Group (ECOG) performance status (PS) is one of the most commonly used assessment tools among oncologists and palliative care specialists caring advanced cancer patients. However, the inter-observer difference between the oncologist and palliative care specialist has never been reported. Methods: We retrospectively reviewed the medical records of all patients who were first referred to an outpatient palliative care clinic in 2013 and identified 278 eligible patients. The ECOG PS assessments by palliative care specialists, nurses, and oncologists, and the symptom burden measured by Edmonton Symptom Assessment Scale (ESAS) were analyzed. Results: According to the pairwise comparisons using Sign tests, palliative care specialists rated the ECOG PS grade significantly higher than oncologists (median 0.5 grade, P<0.0001) and nurses also rated significantly higher (median 1.0 grade, P<0.0001). The assessments of palliative care specialists and nurses were not significantly different (P=0.10). Weighted kappa values for inter-observer agreement were 0.26 between palliative care specialists and oncologists, and 0.61 between palliative care specialists and nurses. Palliative care specialists’ assessments showed a moderate correlation with fatigue, dyspnea, anorexia, feeling of well-being, and symptom distress score measured by ESAS. The ECOG PS assessments by all three groups were significantly associated with survival (P<0.001), but the assessments by oncologists could not distinguish survival of patients with PS 2 from 3. Independent predictors of discordance in PS assessments between palliative care specialists and oncologists were the presence of an effective treatment option (odds ratio [OR] 2.39, 95% confidence interval [CI] 1.09-5.23) and poor feeling of well-being (≥4) by ESAS (OR 2.38, 95% CI 1.34-4.21). Conclusions: ECOG PS assessments by the palliative care specialists and nurses were significantly different from the oncologists. Systematic efforts to increase regular interdisciplinary meetings and communications might be crucial to bridge the gap and establish a best care plan for each advanced cancer patients.

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Verbalized desire for death or euthanasia in advanced cancer patients receiving palliative care

Palliative & Supportive Care ◽

10.1017/s1478951514000121 ◽

2014 ◽

Vol 13 (2) ◽

pp. 295-303 ◽

Cited By ~ 7

Author(s):

Ernest Güell ◽

Adelaida Ramos ◽

Tania Zertuche ◽

Antonio Pascual

Keyword(s):

Palliative Care ◽

Cancer Patients ◽

Terminally Ill ◽

Well Being ◽

Semistructured Interview ◽

Advanced Cancer Patients ◽

Terminally Ill Cancer Patients ◽

Symptom Intensity ◽

Edmonton Symptom Assessment Scale ◽

Desire To Die

AbstractObjective:We aimed to address the prevalence of desire-to-die statements (DDSs) among terminally ill cancer patients in an acute palliative care unit. We also intended to compare the underlying differences between those patients who make desire-to-die comments (DDCs) and those who make desire-for-euthanasia comments (EUCs).Method:We conducted a one-year cross-sectional prospective study in all patients receiving palliative care who had made a DDC or EUC. At inclusion, we evaluated symptom intensity, anxiety and depression, and conducted a semistructured interview regarding the reasons for these comments.Results:Of the 701 patients attended to during the study period, 69 (9.8%; IC95% 7.7–12.3) made a DDS: 51 (7.3%) a DDC, and 18 (2.5%) an EUC. Using Edmonton Symptom Assessment Scale (ESAS) DDC group showed higher percentage of moderate-severe symptoms (ESAS > 4) for well-being (91 vs. 25%; p = 0.001), depression (67 vs. 25%; p = 0.055), and anxiety (52 vs. 13%; p = 0.060) than EUC group. EUC patients also considered themselves less spiritual (44 vs. 84%; p = 0.034). The single most common reason for a DDS was pain or physical suffering, though most of the reasons given were nonphysical.Significance of results:Almost 10% of the population receiving specific oncological palliative care made a DDC (7.3%) or EUC (2.5%). The worst well-being score was lower in the EUC group. The reasons for both a DDC and EUC were mainly nonphysical. We find that emotional and spiritual issues should be identified and effectively addressed when responding to a DDS in terminally ill cancer patients.

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Assessing hope at the end of life: Validation of an experience of hope scale in advanced cancer patients

Palliative & Supportive Care ◽

10.1017/s1478951504040337 ◽

2004 ◽

Vol 2 (3) ◽

pp. 243-253 ◽

Cited By ~ 26

Author(s):

CHERYL L. NEKOLAICHUK ◽

EDUARDO BRUERA

Keyword(s):

Palliative Care ◽

Cancer Patients ◽

Advanced Cancer ◽

Symptom Assessment ◽

Well Being ◽

Assessment System ◽

Validity Evidence ◽

Advanced Cancer Patients ◽

Factor I ◽

Factor Ii

Objective:The purpose of this study was to gather validity evidence for an innovative experience of hope scale, theHope Differential-Short (HDS), and evaluate its clinical utility for assessing hope in advanced cancer patients.Methods:A consecutive sampling approach was used to recruit 96 patients from an inpatient tertiary palliative care unit and three hospice settings. Each participant completed an in-person survey interview, consisting of the following measures: HDS (nine items), Herth Hope Index (HHI), hope visual analog scale (Hope-VAS) and Edmonton Symptom Assessment System (ESAS).Results:Using factor analytic procedures, a two-factor structure for the HDS was identified, consisting ofauthentic spirit(Factor I) andcomfort(Factor II). The HDS factors had good overall internal consistency (α = 0.83), with Factor I (α = 0.83) being higher than Factor II (α = 0.69). The two factors positively correlated with the HHI, Hope-VAS, and one of the ESAS visual analog scales, well-being (range: 0.38 to 0.64) and negatively correlated with depression and anxiety, as measured by the ESAS (range: −0.25 to −0.42).Significance of results:This is the first validation study of the HDS in advanced cancer patients. Its promising psychometric properties and brief patient-oriented nature provide a solid initial foundation for its future use as a clinical assessment measure in oncology and palliative care. Additional studies are warranted to gather further validity evidence for the HDS before its routine use in clinical practice.

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Pharmacological management update: clinical significance of anamorelin clinical trials for the treatment of cancer cachexia in advanced cancer patients

Translational Cancer Research ◽

10.21037/tcr.2016.09.10 ◽

2016 ◽

Vol 5 (S3) ◽

pp. S491-S496

Author(s):

Terence Rong De Ng ◽

Eduardo Bruera ◽

Sriram Yennurajalingam

Keyword(s):

Clinical Trials ◽

Cancer Patients ◽

Clinical Significance ◽

Advanced Cancer ◽

Cancer Cachexia ◽

Advanced Cancer Patients ◽

Pharmacological Management

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Advanced cancer patients’ changes in terminal illness understanding (TIU) and their psychological well-being.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.11617 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 11617-11617

Author(s):

Megan Johnson Shen ◽

Paul K. Maciejewski ◽

Andrew S. Epstein ◽

Holly Gwen Prigerson

Keyword(s):

Life Expectancy ◽

Cancer Patients ◽

Advanced Cancer ◽

Psychological Symptoms ◽

Treatment Decision ◽

Well Being ◽

Advanced Cancer Patients ◽

Psychological Well Being ◽

Change Scores

11617 Background: Although accurate TIU is necessary for informed treatment decision-making, clinicians worry that patients’ recognition of the terminal nature of their illness may lower psychological well-being. This study examines if such recognition is associated with lowered psychological well-being, that persists over time. Methods: Data came from 87 advanced cancer patients, with a life expectancy of less than 6 months. Patients were assessed pre and post an oncology visit to discuss cancer restaging scan results, and again one month later (follow-up). TIU was assessed at pre and post as the sum of four indicator variables — understanding of terminal nature of illness, curability, stage, and life-expectancy — and a TIU change score was computed (post minus pre). Psychological well-being (psychological symptoms subscale, McGill questionnaire) was assessed at pre, post, and follow-up, and two change scores were computed (post minus pre; follow-up minus post). Results: Changes toward more accurate TIU was associated with a corresponding decline in psychological well-being ( r = -0.33, p < .01), but thereafter was associated with subsequent improvements in psychological well-being ( r = .40, p < .001). This pattern persisted even after adjustment for relevant demographic factors, prognostic discussion, scan results, and physical well-being change. TIU change scores ranged from positive to negative, with some participants showing improvements in TIU ( n = 19), some showing decrements in TIU ( n = 14), and others showing stable TIU ( n = 54). Among patients with improved TIU, psychological well-being initially decreased, but subsequently recovered [7.03 (2.23) to 6.30 (1.80), to 7.63 (2.08)]; the stable TIU group showed relatively unchanged well-being [7.34 (2.37) to 7.45 (2.32), to 7.36 (2.66)], and the less accurate TIU group showed an initial improvement followed by a subsequent decline [6.30 (2.62) to 7.36 (2.04), to 5.63 (3.40)]. Conclusions: Improved TIU may be associated with initial decrements in psychological well-being, followed by patients rebounding to baseline levels. Concerns about psychological harm may not need to be a deterrent to having prognostic discussions with patients.

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Chronic conditions among advanced cancer patients and their spouse caregivers.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.31_suppl.20 ◽

2019 ◽

Vol 37 (31_suppl) ◽

pp. 20-20

Author(s):

Dana Ketcher ◽

Amy Otto ◽

Maija Reblin

Keyword(s):

Cancer Patients ◽

Advanced Cancer ◽

Chronic Conditions ◽

Well Being ◽

Medical Decision ◽

Depression Symptoms ◽

Multiple Chronic Conditions ◽

Psychological Consequences ◽

Advanced Cancer Patients ◽

Spouse Caregivers

20 Background: Chronic conditions and multimorbidity have been recognized to have negative impacts on costs of healthcare, quality of care, and well-being. The interdependence of patients and caregivers has also been highlighted, in that patient factors can impact caregiver outcomes and vice versa. Yet little research has been conducted on how the number of other health conditions among spouse caregivers (CGs) and advanced cancer patients impact their own and their partners’ well-being. Methods: Data were gathered as part of a prospective observational study of couples coping with advanced cancer. Patients had to have a cohabiting spouse/partner who identified as providing some care and also agreed to participate. Results: Patients rated their overall health slightly worse (scale 1-5, M = 2.85, SD = 0.95) than CGs ( M = 2.27, SD = 0.75). Patients also reported more total conditions ( M = 2.59, SD = 1.42) than CGs ( M = 1.4, SD = 1.14). Most patients (81%) reported at least one chronic condition other than cancer (44% of patients reported at least two other conditions); the most common conditions among patients were hypertension (43%), lung disease (36%), arthritis, and diabetes (both 24%). About 23% of CGs reported having no chronic conditions; 36% reported at least one and 41% reported at least two. The most common conditions among CGs were arthritis (40%), hypertension (39%), and heart disease, diabetes, and cancer (13% each). A greater number of CG conditions predicted greater depression symptoms in the patient ( B = 0.60, p = .040), controlling for patient conditions. More conditions among patients was a significant predictor of less patient social support ( B = -0.67, p = .017) and a marginally-significant predictor of greater perceived stress among caregivers ( B = -0.27, p = .064). A history of CG cancer predicted greater depression symptoms in the patient ( B = 2.3, p = .02). Conclusions: Chronic conditions and multimorbidity can have significant psychological consequences for both patient and CG. Clinicians, in addition to making an active effort to incorporate CGs into medical decision making and treatment planning, should also be aware of patient and caregiver multiple chronic conditions in order to provide more holistic care for patients.

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