Communicating the introduction of psychology services in the palliative care (PC) cancer setting: A randomized double blind trial.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 129-129
Author(s):  
Sujin Ann-Yi ◽  
Kimberson Cochien Tanco ◽  
Cindy L. Carmack ◽  
Diane D. Liu ◽  
Swati Bansal ◽  
...  

129 Background: Despite high distress and empirical support for psychosocial services for cancer patients, the utilization of these services continue to be low. Our aims are to ascertain if the manner of introducing psychology services impact patients’ acceptance of services and identify factors associated with acceptance and barriers of psychology utilization. Methods: 100 PC cancer patients who have not received prior psychology services were randomized to observe two video vignettes: one showed a physician introducing a counselor and psychology services to the patient (PI); another showed a counselor entering and introducing psychology services alone (CI). Randomization was stratified using baseline Hospital Anxiety and Depression Scale scores. After viewing both videos, patients completed a survey regarding preference, attitudes, and barriers for psychology services. Patients were blinded regarding the purpose of the study and investigators were blinded to content and order of videos presented. Results: 64 patients reported a preference with 34 preferring PI (p=0.37) and 36 reporting no difference. Younger patients preferred PI (85.7%) versus CI (14.3%, p=0.03). Most reported being aware of available psychology services (N=63), and half (N=50) had been offered psychology services by their physician. Only 40 (40%) patients felt psychology services would be helpful for them, and 43 (43%) reported it would be beneficial for their family/caregivers. Those who found it helpful for themselves or family had higher anxiety than those who did not find it helpful (p=0.03 and p=.02 respectively). The most commonly endorsed barriers for psychology services were travel (N=25) and finances (N=21). Conclusions: We found no significant difference in preference of introduction of psychology services except in patients less than 40 years old who preferred PI. Patients with higher anxiety felt psychology services were helpful for self and family. Only 40% perceived psychology services as useful for self and family. More research is needed to investigate the most effective approach for introducing psychology services to increase perception of usefulness and utilization in cancer patients. Clinical trial information: NCT03035448.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
Amelie Sylvia Mary Harle ◽  
Jaclyn A Smith ◽  
Alex Molassiotis ◽  
Kimberley Lofthouse ◽  
Rachel Dockry ◽  
...  

2 Background: There are no evidence-based therapies for cough in lung cancer (LC).The neurokinin-1 (NK-1) pathway is implicated in cough. Aprepitant is an NK-1 antagonist used as an antiemetic. We assess aprepitant as an antitussive, using objective daytime ambulatory cough monitoring (ACM) as the primary endpoint. Methods: LC patients with a “bothersome” cough were enrolled on an exploratory single-arm randomised double-blind crossover trial and received 125mg aprepitant on day 1 and 80mg on days 2 and 3 or matched placebo capsules. After a 3 day wash out,patients crossed over to placebo or aprepitant for 3 days (days 7-9). They completed ACM and validated subjective cough tools. Results: 20 LC patients were enrolled between 7th Oct 2013-3rd Nov 2014; mean age 66 yrs (SD 7.69); 60% (n=12) female; 70% (n=14) ex, 25% (n=5) current and 5% (n=1) never smokers respectively. 20% (n=4), 55% (n=11) and 25% (n=5) had a performance status of 0, 1 and 2 respectively. The majority (80% n=16) had non-small cell LC; half (n=10) had advanced stage; 20% (n=4) were on anticancer therapy. Daytime cough frequency was 15.9 (95%CI 10.1-28.3 n=19), 12.8 (95% CI 8.7-18.8 n=18) and 16.2 (11.3-23.0 n=19) coughs/hr at baseline, on aprepitant and on placebo respectively: p=0.03. Visual analogue scale scores (range 0-100, high score=worse severity) were 57.0mm (95% CI 47.4-67.2 n=19), 40.8mm, (95%CI 34.3-47.3 n=18), and 49.8mm (95%CI 44.2-55.4 n=19) at baseline, on aprepitant and on placebo respectively: p=0.008. The Manchester Cough in Lung Cancer Scale score (range 1-50, high score = worse cough impact) was 25.2 (95%CI 23.0-28.0 n=19), 19.5 (95%CI 17.8-21.2 n=18) and 21.7 (20.3-23.1 n=18) at baseline, on aprepitant and on placebo respectively: p<0.001.There were no serious adverse events. Conclusions: This is the first trial to assess the efficacy of a novel antitussive using validated subjective and objective cough tools in LC and the first to investigate a centrally acting NK-1 antagonist in humans. Aprepitant treatment was associated with statistically significant improvements in objective and subjective scores. The NK-1 receptors may be key mediators in cough in LC. It is possible to run a robust trial using validated measures with clinically meaningful endpoints in a LC population. Clinical trial information: ISRCTN16200035.


2018 ◽  
Vol 52 (6) ◽  
Author(s):  
Roland Dominic G. Jamora ◽  
Rosalia A. Teleg ◽  
Cynthia P. Cordero ◽  
Rodelyn F. Villareal-Jordan ◽  
Lillian V. Lee ◽  
...  

Objective. X-linked dystonia parkinsonism (XDP) is an adult-onset, progressive and debilitating movement disorder described among Filipino males from Panay Island. The available oral medications have been ineffective. While chemodenervation with botulinum toxin A works and deep brain stimulation surgery is promising, these are not affordable for the vast majority of patients. Thus, we decided to look into the efficacy, safety and tolerability of levodopa+carbidopa (levodopa) versus placebo among patients with XDP. Methods. This was a double blind, randomized, placebo-controlled clinical trial. Patients were randomized to receive levodopa or placebo for 6 months. The dose was increased gradually until 1000 mg levodopa/day is reached or until side effects appear. Results. A total of 86 out of 94 randomized patients (91.5%) were included in the intention-to-treat cohort for the primary efficacy analysis. Nineteen patients (9 in levodopa, 10 in placebo) dropped out or were lost to follow up. There was no significant difference in the baseline and last visit Burke Fahn Marsden Dystonia Rating Scale and the part III of the Unified Parkinson’s Disease Rating Scale scores between levodopa and placebo. The most common adverse events in the levodopa group were increased movements, pain and nausea/ vomiting. Conclusion. While levodopa is safe and well-tolerated, it does not have any effect in alleviating the dystonia or parkinsonism in XDP


2018 ◽  
Vol 1 (1) ◽  
pp. 42
Author(s):  
Perjuangan Dapot Hamonangan Simbolon ◽  
Selvi Nafianti ◽  
Pertin Sianturi ◽  
Bidasari Lubis ◽  
Aznan Lelo

Background Chemotherapy-induced nausea and vomiting are some of the most disturbing side effects in pediatric cancer patients. The standard recommendation is the use of 5-hydroxytryptamine 3 receptor antagonist, such as ondansetron, to treat these symptoms. Despite this treatment, more than 50% of patients still experience nausea and vomiting.Objective To evaluate the effect of the addition of omeprazole to ondansetron in the treatment of chemotherapy-induced nausea and vomiting.Methods A double-blind, randomized, controlled trial was conducted at Haji Adam Malik Hospital, Medan, North Sumatera, from March to May 2016. Subjects were children aged 1 to 18 years, diagnosed with cancer, and who received intravenous chemotherapy. Patients were randomized to receive either a single dose of ondansetron (0.5 mg/kg) plus placebo or ondansetron (0.5 mg/kg) plus omeprazole (0.5 mg/kg). The severity of nausea and vomiting were measured using the Rhodes index of nausea, vomiting, and retching during the 24 hours after initiation of emetogenic chemotherapy. The primary outcome of efficacy was the proportion of patients who achieved complete response (lack of nausea/vomiting). Statistical analysis was performed by Chi-square and Fischer’s exact tests.Results Seventy eligible pediatric patients were randomized into two groups: 32 subjects in the ondansetron + placebo group and 38 others in the ondansetron + omeprazole group. The therapy failed in 50% (16/32) of the ondansetron + placebo group and 18.4% (7/38) of the ondansetron + omeprazole group. There was a significant difference in the clinical response between groups (P=0.01).Conclusion The addition of omeprazole to ondansetron for the treatment of chemotherapy-induced nausea and vomiting is more effective than administration of ondansetron alone.


2020 ◽  
Author(s):  
yuan hu ◽  
yichen wang ◽  
chao chen ◽  
wenshan yang ◽  
weiyu zhu ◽  
...  

Abstract Objective: Kaixinsan (KXS) decoction, as an ancient’s herbal formula, has been demonstrated to be active in various animal models resembling human depression with multi-target effects. This very first study evaluated the efficacy and tolerability of Shen Zhi Ling (SZL) tables (KXS preparation), compared with fluoxetine (FLX, positive comparator), in patients with mild to moderate depressive disorder.Methods: In this randomized double-blind parallel-group study, 156 patients with mild to moderate depression without taken any antidepressants in the past 6 months or 4 straight weeks were randomized to receive either 3.2g/d SZL plus 20mg/d FLX placebo (SZL group) or 20mg/d FLX plus 3.2g/d SZL placebo (FLX group), for 8 weeks. Their clinical presentations and some metabolic indexes were assessed during the 8 weeks visiting period.Results: Patients in SZL group showed a statistically significant improvement after 8 weeks of treatment in HAMD-17 score (18.79±2.09 to 4.43±4.71, p<0.001) and self-rating depression scale (SDS) score (58.49±8.89 to 39.84±12.09, p<0.001), but not in N-back total respond time (1145.55±608.26 to 1128.47±387.49, p>0.05). In addition, no significant difference at 8 weeks of treatment was found between SZL and FLX groups in SDS score (39.84±12.09 vs. 36.63±12.44) and N-back respond time (1128.47±387.49 vs. 1089.43±352.08) as well as reduction of HAMD-17 score (14.79±4.88 vs. 15.24±4.29) (p>0.05 for all). However, the serum APOB, APOC3 and ALB levels and HDL-C/LDL-C ratio decreased significantly in patients after SZL treatment, while only APOB/APOA1 ratio decreased significantly in FLX group. Other metabolic indexes did not alter significantly after treated with SZL or FLX.Conclusion: The efficacy and safety profile of SZL are comparable to that of fluoxetine in patients with mild to moderate depression. The beneficial effect of SZL is probably associated with improvement of lipid metabolic balance.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9103-9103
Author(s):  
Ting Bao ◽  
Kelly Betts ◽  
Karineh Tarpinian ◽  
Ling Cai ◽  
Jeff Gould ◽  
...  

9103 Background: Aromatase Inhibitors (AIs) have been associated with worsening of patient related outcomes (PROs) such as AIMSS, menopausal symptoms and depression. Acupuncture has been reported to alleviate such symptoms. We hypothesized that real acupuncture (RA) would improve PROs more than sham acupuncture (SA). Methods: We collected PROs at baseline, 4, 8, and 12 weeks (wks), from women enrolled in a multi-center double blind RCT designed to assess the effect of acupuncture in reducing PROs. Patients were randomized to 8 wkly RA or SA. PROs were measured by the revised National Surgical Adjuvant Breast and Bowel Project (NSABP) menopausal symptoms questionnaire, Center for Epidemiological Studies Depression Scale (CESD), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), Hot Flash Daily Diary, Hot Flash Related Daily Interference Scale (HFRDI) and EuroQoL survey. We measured estrogen and cytokines concentrations at baseline and wk 8. We used Wilcoxon rank sum and signed-rank tests to make comparisons between and within group, respectively. Results: We included 23 patients from RA and 24 from SA arms in the intent-to-treat analysis. We have previously reported no significant difference in reduction of AIMSS between two arms. RA caused reduction of CESD scores compared to SA (median: -2 vs 0, p = 0.057). When compared to baseline, there were statistically significant improvements at wk 8 in hot flash severity score (p=0.006), hot flash frequency (p=0.011), HFRDI (p=0.014) and NSABP menopausal symptoms (p=0.022) scores in RA arm; for EuroQoL (p=0.022), HFRDI (p=0.043) and NSABP menopausal symptoms (p=0.005) scores in SA arm. The majority of patients’ estradiol concentrations were undetectable at baseline and wk 8. Changes in other time points, data and analysis of cytokines changes will be presented at the meeting. Conclusions: Real and sham acupuncture were both associated with improvement in PROs in breast cancer patients taking AIs. We detected no significant difference in the change of PROs between real and sham acupuncture, except for CESD.


2021 ◽  
pp. 1-11
Author(s):  
Wenying Du ◽  
Changchang Ding ◽  
Jiehui Jiang ◽  
Ying Han

Background: Mounting evidence suggests that sex differences exist in cognitive reserve (CR) for cognitively unimpaired (CU) elderly individuals. Global left frontal connectivity (gLFC connectivity) is a reliable neural substrate of CR. Objective: The purpose of this study was to explore sex differences in gLFC connectivity among CU elderly individuals. Methods: One hundred thirteen normal controls (NCs) (women = 66) and 132 individuals with subjective cognitive decline (SCD) (women = 92) were recruited from the Sino Longitudinal Study on Cognitive Decline (SILCODE) (data 1). Among them, 88 subjects underwent amyloid-β (Aβ) imaging, including 32 Aβ+ and 56 Aβ–subjects. Forty-six subjects underwent another rs-fMRI examination (data 2) to validate the repeatability of the calculation of gLFC connectivity, which was determined through seed-based functional connectivity between the LFC and voxels throughout the whole brain. Independent-sample t-tests were used to evaluate the sex differences in gLFC connectivity across different subgroups (NC versus SCD, Aβ+ versus Aβ–). Partial correlation analysis was used to calculate the correlations between gLFC connectivity and cognitive assessments. Results: Women exhibited lower gLFC connectivity in both the NC (p = 0.001) and SCD (p = 0.020) subgroups than men. Women also exhibited lower gLFC connectivity in both the Aβ–(p = 0.006) and Aβ+ (p = 0.025) groups. However, the significant difference disappeared in the Aβ+ group when considering the covariates of age, education, total intracranial volume, and APOE4-carrying status. In addition, gLFC connectivity values were negatively correlated with Geriatric Depression Scale scores in the SCD group (r = –0.176, p = 0.047). Conclusion: Women showed lower gLFC connectivity among CU elderly individuals.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19643-e19643
Author(s):  
Kalyan Pulivarthi ◽  
Rony Dev ◽  
Jose Garcia ◽  
J. Lynn Palmer ◽  
Eduardo Bruera ◽  
...  

e19643 Background: Hypogonadism affects two thirds of men with advanced cancer. Uncontrolled studies show fatigue, anorexia, depression,and insomnia are associated with low testosterone in men with cancer. Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions. The primary goal of this study was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)at day 29. Methods: Randomized, double-blinded placebo controlled at two centers. Clinic outpatients with advanced cancer, bioavailable testosterone (BT) <70ng/dL, hemoglobin>9g/dL, and moderate to severe fatigue assessed by a score >3/10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible.Contraindications to testosterone therapy or other causes of fatigue such as hypothyroidism, hypercalcemia, or chronic kidney disease excluded subjects. Weight-based intra-muscular testosterone or a sesame seed oil placebo administered every 14 days to achieve a BT level 70-270ng/dL. Initial sample size was for fifty evaluable patients per group. One-sided t test was used to analyze differences in FACIT scores between arms. Results: Accrual was slower than anticipated with a final total of 43 eligible males randomized to testosterone(19) or placebo(24). Neither age nor site was statistically significant (<0.05) between arms. 14 placebo and 12 testosterone treated patients were evaluable for the primary outcome.No statistically significant difference was found for FACIT-F total scores between arms, with a trend for testosterone to improve scores (-5.5±19 for placebo, 3.9±14 for testosterone, p=0.09) using a one-sided t test. Adverse events were similar between groups. There were no significant differences in secondary outcomes of ESAS scores, Hospital Anxiety and Depression Scale, hand-grip or 6 minute walk. Conclusions: Testosterone replacement in hypogonadal male patients with advanced cancer had a trend to improve fatigue and quality of life in this preliminary trial.


2013 ◽  
Vol 127 (3) ◽  
pp. 285-294 ◽  
Author(s):  
L A Joseph ◽  
J A Routledge ◽  
M P Burns ◽  
R Swindell ◽  
A J Sykes ◽  
...  

AbstractBackground:Few studies have prospectively investigated psychological morbidity in UK head and neck cancer patients. This study aimed to explore changes in psychological symptoms over time, and associations with patients' tumour and treatment characteristics, including toxicity.Methods:Two hundred and twenty patients were recruited to complete the Hospital Anxiety and Depression Scale and the Late Effects on Normal Tissue (Subjective, Objective, Management and Analytic) (‘LENT-SOMA’) questionnaires, both pre- and post-treatment.Results:Anxiety was highest pre-treatment (38 per cent) and depressive symptoms peaked at the end of treatment (44 per cent). Anxiety significantly decreased and depression significantly increased, comparing pre- versus post-treatment responses (p < 0.001). Hospital Anxiety and Depression Scale scores were significantly correlated with toxicity, age and chemotherapy (p < 0.01 for all).Conclusion:This is the first study to analyse the relationship between Hospital Anxiety and Depression Scale scores and toxicity scores in head and neck cancer patients. It lends support for the use of the Hospital Anxiety and Depression Scale and the Late Effects on Normal Tissue (Subjective, Objective, Management and Analytic) questionnaire in routine clinical practice; furthermore, continued surveillance is required at multiple measurement points.


1995 ◽  
Vol 13 (4) ◽  
pp. 1004-1008 ◽  
Author(s):  
F De Conno ◽  
C Ripamonti ◽  
L Saita ◽  
T MacEachern ◽  
J Hanson ◽  
...  

PURPOSE The aim of this double-blind, double-dummy, crossover study was to compare the efficacy, tolerability, and time of onset of analgesia after the administration of 10 mg of morphine hydrochloride via the oral and rectal routes in opioid-naive cancer patients with pain. PATIENTS AND METHODS Thirty-four patients with cancer pain and no previous opioid treatment were randomized to receive morphine hydrochloride 10 mg orally or rectally (in the form of a microenema) for 2 days. During days 3 and 4, a crossover took place. The scores of pain, nausea, and sedation (visual analog scale of 0 to 100) calculated as the percentage change from baseline (before opioid administration) were assessed at different intervals up to 240 minutes. The number of vomiting episodes was recorded. Parity tests and analysis of variance (ANOVA) were performed to compare the two administration routes. RESULTS A significant difference in pain intensity was achieved 10 minutes after rectal administration compared with 60 minutes after oral administration. There was still a significant reduction in pain via the rectal route after 180 minutes versus via the oral route after 120 minutes. No significant difference was observed in the intensity of sedation, nausea, or number of vomiting episodes between the oral and rectal routes. CONCLUSION A liquid solution of morphine is well absorbed via the rectal route. Rectal morphine is safe, effective, easy to manage, and inexpensive, with a rapid onset of action. Rectal morphine can be considered a valid alternative route for opioid administration and may also be used when rescue doses of morphine are required in patients regularly treated with oral or parenteral opioids.


2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Fiona L. Mackie ◽  
Helen Pattison ◽  
Jelena Jankovic ◽  
R. Katie Morris ◽  
Mark D. Kilby

Abstract Background Twin-twin transfusion syndrome (TTTS) is a highly morbid condition in which treatment exists, but the pregnancy remains high-risk until delivery. It may have serious sequelae, including fetal death, and in the longer term, neurodevelopmental problems. The aim of this study is to assess antenatal and postnatal parental attachment and depressive symptoms in those with pregnancies affected by TTTS. Methods Couples attending for fetoscopic laser ablation treatment of TTTS were asked to complete Condon’s Maternal/Paternal Antenatal/Postnatal Attachment Scale as appropriate, and the Edinburgh Depression Scale the day before ablation, 4 weeks post-ablation, and 6–10 weeks postnatally. Results 25/27 couples completed the pre-ablation questionnaire (median gestational age 19 + 3 weeks [interquartile range 18 + 2–20 + 6]). 8/18 eligible couples returned the post-ablation questionnaire. 5/17 eligible couples returned the postnatal questionnaire. There was no significant difference in parento-fetal attachment when mothers were compared to fathers at each time point, however parento-fetal attachment did increase over time in mothers (p = 0.004), but not fathers. Mothers reported more depressive symptoms antenatally compared to fathers (p < 0.02), but there was no difference postnatally. 50% women reported Edinburgh Depression Scale scores above the cut-off (≥15) 4 weeks post-ablation. Over time maternal depressive symptoms decreased (p = 0.006), however paternal depressive symptoms remained the same. Conclusions This is the first attachment and depression study in a UK cohort of parents with pregnancies affected by TTTS. Although this was a small cohort and the questionnaires used had not been validated in these circumstances, the results suggest that centres caring for these couples should be aware of the risk of maternal and paternal antenatal depression, and screen and refer for additional psychological support. Further work is needed in larger cohorts. Trial registration ISRCTN 13114861 (retrospectively registered).


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