Fluoxetine Versus Placebo in Advanced Cancer Outpatients: A Double-Blinded Trial of the Hoosier Oncology Group

2003 ◽  
Vol 21 (10) ◽  
pp. 1937-1943 ◽  
Author(s):  
Michael J. Fisch ◽  
Patrick J. Loehrer ◽  
Jean Kristeller ◽  
Steven Passik ◽  
Sin-Ho Jung ◽  
...  

Purpose: To determine whether fluoxetine improves overall quality of life (QOL) in advanced cancer patients with symptoms of depression revealed by a simple survey. Patients and Methods: One hundred sixty-three patients with an advanced solid tumor and expected survival between 3 and 24 months were randomly assigned in a double-blinded fashion to receive either fluoxetine (20 mg daily) or placebo for 12 weeks. Patients were screened for at least minimal depressive symptoms and assessed every 3 to 6 weeks for QOL and depression. Patients with recent exposure to antidepressants were excluded. Results: The groups were comparable at baseline in terms of age, sex, disease distribution, performance status, and level of depressive symptoms. One hundred twenty-nine patients (79%) completed at least one follow-up assessment. Analysis using generalized estimating equation modeling revealed that patients treated with fluoxetine exhibited a significant improvement in QOL as shown by the Functional Assessment of Cancer Therapy–General, compared with patients given placebo (P = .01). Specifically, the level of depressive symptoms expressed was lower in patients treated with fluoxetine (P = .0005), and the subgroup of patients showing higher levels of depressive symptoms on the two-question screening survey were the most likely to benefit from treatment. Conclusion: In this mix of patients with advanced cancer who had symptoms of depression as determined by a two-question bedside survey, use of fluoxetine was well tolerated, overall QOL was improved, and depressive symptoms were reduced.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS6651-TPS6651
Author(s):  
Gillian Gresham ◽  
Andrew Eugene Hendifar ◽  
Jun Gong ◽  
Arash Asher ◽  
Christine S. Walsh ◽  
...  

TPS6651 Background: Advanced cancer patients undergo dynamic changes in their functionality and physical activity over the course of their treatment. Monitoring patient function is important because it can inform treatment decisions and allow for timely and appropriate intervention. Current scales that assess patient function, such as the ECOG Performance Status (PS), are limited in their ability to capture the wide range in activity that cancer patients can experience on a daily basis outside of the clinic setting. Given recent technological advances in wearable activity monitors, we can collect real-time, objective information about a patient’s daily activity including steps, stairs, heart rate, sleep, and activity intensity. Thus, the primary objective of this study is to determine whether longitudinal changes in objectively-assessed activity are associated with change in physician-rated ECOG PS. Methods: This is a prospective, single cohort trial being conducted at Cedars-Sinai Medical Center. Stage 3/4 cancer patients who are English or Spanish-speaking, ambulatory (assistive walking devices are allowed) and expected to be seen for treatment or follow-up with their oncologist at least every 8 weeks are eligible for study. Consenting patients will be asked to wear a Fitbit Charge HR continuously for 8 weeks during the study period and for one week prior to the 6 month and 1 year follow-up visits. Primary outcomes are change in average daily step counts and ECOG PS at 8 weeks from baseline. Secondary outcomes include: 1) Change in NIH PROMIS patient-reported outcomes (physical function, pain, sleep, emotional distress, and fatigue), 2) Change in frailty status at 8 weeks, 3) Occurrence of adverse events, and 4) 6-month and 1-year survival outcomes. Baseline assessments include a physical exam, medical history, and frailty assessment. The attending oncologist will rate the patient's ECOG PS at baseline and at the end-of-study visit. Weekly NIH PROMIS questionnaires will be administered online over the 8-week study and again at 6 months and 1 year follow-up. The occurrence of serious cancer-related adverse events, chemotherapy-associated toxicities, and hospitalizations will be documented up to 12 weeks from baseline. Survival will be assessed at 6 months and 1 year. Accrual is ongoing with 20 patients currently enrolled of a target sample size of 60 patients. Clinical trial information: NCT03757182.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Johanna Sommer ◽  
Christopher Chung ◽  
Dagmar M. Haller ◽  
Sophie Pautex

Abstract Background Patients suffering from advanced cancer often loose contact with their primary care physician (PCP) during oncologic treatment and palliative care is introduced very late. The aim of this pilot study was to test the feasibility and procedures for a randomized trial of an intervention to teach PCPs a palliative care approach and communication skills to improve advanced cancer patients’ quality of life. Methods Observational pilot study in 5 steps. 1) Recruitment of PCPs. 2) Intervention: training on palliative care competencies and communication skills addressing end-of-life issues. 3) Recruitment of advanced cancer patients by PCPs. 4) Patients follow-up by PCPs, and assessment of their quality of life by a research assistant 5) Feedback from PCPs using a semi-structured focus group and three individual interviews with qualitative deductive theme analysis. Results Eight PCPs were trained. Patient recruitment was a challenge for PCPs who feared to impose additional loads on their patients. PCPs became more conscious of their role and responsibility during oncologic treatments and felt empowered to take a more active role picking up patient’s cues and addressing advance directives. They developed interprofessional collaborations for advance care planning. Overall, they discovered the role to help patients to make decisions for a better end-of-life. Conclusions While the intervention was acceptable to PCPs, recruitment was a challenge and a follow up trial was not deemed feasible using the current design but PCPs reported a change in paradigm about palliative care. They moved from a focus on helping patients to die better, to a new role helping patients to define the conditions for a better end-of-life. Trial registration The ethics committee of the canton of Geneva approved the study (2018–00077 Pilot Study) in accordance with the Declaration of Helsinki.


2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 77-77
Author(s):  
Stephanie Gilbertson-White ◽  
Michelle Weckmann ◽  
Heidi Donovan ◽  
Paula R Sherwood

77 Background: Patients with advanced cancer often need specialized palliative care (PC) for aggressive symptom management as their cancer progresses. The purpose of this study is to evaluate the feasibility of following patients with advanced cancer referred to PC for symptom management. The aims are to: 1) describe survival status at 12-wks post PC referral, and 2) compare time to PC referral, performance status, and quality-of-life (QOL) at baseline across survival status groups. Methods: Patients (N=20) with advanced cancer newly referred to PC were recruited. Date of cancer diagnosis, date of referral to PC, and survival status were abstracted from the medical record. The number of weeks was calculated from the date of cancer diagnosis to the date of PC referral. Palliative Performance Status (PPS) scale was used to measure performance status. Higher % scores indicate better performance status. SF-36 was used to measure QOL. Higher scores indicate higher perceived QOL. Results: At 12-weeks post PC referral, 6 patients were alive, 8 patients were lost to follow-up, and 6 patients had died. Missed appointments with PC or cessation of cancer treatments were primary reasons patients were lost to follow-up. Patients alive at 12-wks had the best PPS scores at baseline (mean=58%) and the shortest length of time between cancer diagnosis and PC referral (mean=81.5 wks). Patients lost to follow-up had the worst PPS scores at baseline (mean=44%) and the longest time to PC referral (mean=745 wks). No differences were found on the SF-36 subscale scores. Conclusions: Performance status was a strong predictor of survival status at 12-wks post PC referral. Patients with the longest time between diagnosis and PC referral were most likely to be lost to follow-up. All patients with advanced cancer reported significant declines in QOL. Further research is needed to understand how time to PC referral is associated with missed appointments or decisions to stop cancer treatments. Prospective research from the time of diagnosis with advanced cancer through the end-of-life is needed to better understand how PC can help maintain performance status and QOL for as long as possible.


Author(s):  
Franca Tani ◽  
Simon Ghinassi ◽  
Lucia Ponti

Abstract. Background: Depression during pregnancy is a severe risk factor for negative outcomes in women and children. In particular, prenatal symptoms of depression are linked to a more complicated labor experience, characterized by more painful labor and more frequent recourse to epidural analgesia and/or oxytocin. Although this link is evident, less is known about possible mediators of this relationship. Aims: This study investigated the mediating role of perceived maternal social support on the relationship between prenatal maternal depression and labor experience. Methods: Participants were 152 Italian nulliparous women ( Mage = 31.68 years, SD = 4.94). Data were collected at two different times: T1 (at week 30–33 of gestation) women completed the Beck Depression Inventory and the Maternal Social Support Scale; T2 (at childbirth) clinical data regarding labor was registered from hospital records (duration of labor in hours and administration of oxytocin and epidural analgesia in hours). Results: The Structural Equation Modeling showed that prenatal symptoms of depression are linked to a more complicated labor experience (β = .31, p < .001). However, the quality of the maternal social support can mediate this relationship (indirect effect: β = .17, p < .000). Limitations: The complexity of the proposed model, the characteristics of the sample, the variables investigated, and the questionnaires used are discussed. Conclusion: The perception of having a good social network is an important predictor of women’s health in the transition to motherhood, decreasing the negative effect of maternal prenatal depressive symptoms on the quality of women’s labor experience.


1996 ◽  
Vol 14 (10) ◽  
pp. 2836-2842 ◽  
Author(s):  
F De Conno ◽  
L Groff ◽  
C Brunelli ◽  
E Zecca ◽  
V Ventafridda ◽  
...  

PURPOSE The aims of this study were to describe the analgesia, side effects, and dosage and the causes of suspension of treatment in a large sample of advanced cancer patients with pain after treatment with oral methadone from 7 to 90 days. PATIENTS AND METHODS In a retrospective study, data collected for 196 advanced cancer outpatients with moderate to severe pain treated at 8-hour intervals with oral methadone in solution form from February 1993 to February 1995 were analyzed at baseline (time 0) and then at 7, 15, 30, 45, 60, and 90 days. The following parameters were assessed: Karnofsky Performance Status, intensity of pain (using the Integrated Pain Score [IPS], intensity of pain, insomnia, drowsiness, confusion, dry mouth, nausea, vomiting, constipation, and dyspnea (using the Therapy Impact Questionnaire [TIQ], mean daily dose of drug administered, and reasons for withdrawal from study. The period when pain was reduced by > or = 35% with respect to baseline was evaluated with the Palliation Index. The association of the degree of palliation of pain with the age of the patients, tumor site, analgesic treatment taken at baseline, and daily mean dose of methadone administered during the follow-up period was analyzed by means of the Kruskal-Wallis test. RESULTS A reduction in pain intensity with respect to baseline occurred at each analysis time, and in 55.1% of the patients the reduction during the follow-up period was > or = 35% according to the Palliation Index. The mean dose of oral methadone ranged from 14 mg at day 7 to 23.65 mg at day 90. There was an overall worsening of the other symptoms, but a high percentage of the patients reported an amelioration of insomnia with respect to baseline. There was a statistically significant association (P < .0001) between the Palliation Index and the analgesic therapy administered at baseline. Only 11.2% of the patients withdrew from the study due to analgesic inefficacy and 6.6% due to methadone-related side effects (10 patients with drowsiness and three with severe constipation. CONCLUSION Oral methadone administered every 8 hours was shown to be an appropriate analgesic therapy in the treatment of advanced cancer-related pain. The worsening of the other symptoms under study can be considered linked to the progression of the disease, and in fact, only a small percentage of the patients reported methadone-related side effects that warranted suspension of treatment. We consider oral methadone to be a useful analgesic therapy, and it should be considered in clinical practice for the treatment of cancer pain.


Crisis ◽  
2003 ◽  
Vol 24 (2) ◽  
pp. 73-78 ◽  
Author(s):  
Yves Sarfati ◽  
Blandine Bouchaud ◽  
Marie-Christine Hardy-Baylé

Summary: The cathartic effect of suicide is traditionally defined as the existence of a rapid, significant, and spontaneous decrease in the depressive symptoms of suicide attempters after the act. This study was designed to investigate short-term variations, following a suicide attempt by self-poisoning, of a number of other variables identified as suicidal risk factors: hopelessness, impulsivity, personality traits, and quality of life. Patients hospitalized less than 24 hours after a deliberate (moderate) overdose were presented with the Montgomery-Asberg Depression and Impulsivity Rating Scales, Hopelessness scale, MMPI and World Health Organization's Quality of Life questionnaire (abbreviated versions). They were also asked to complete the same scales and questionnaires 8 days after discharge. The study involved 39 patients, the average interval between initial and follow-up assessment being 13.5 days. All the scores improved significantly, with the exception of quality of life and three out of the eight personality traits. This finding emphasizes the fact that improvement is not limited to depressive symptoms and enables us to identify the relative importance of each studied variable as a risk factor for attempted suicide. The limitations of the study are discussed as well as in particular the nongeneralizability of the sample and setting.


Author(s):  
Livia Costa de Oliveira ◽  
Karla Santos da Costa Rosa ◽  
Ana Luísa Durante ◽  
Luciana de Oliveira Ramadas Rodrigues ◽  
Daianny Arrais de Oliveira da Cunha ◽  
...  

Background: Advanced cancer patients are part of a group likely to be more susceptible to COVID-19. Aims: To describe the profile of advanced cancer inpatients to an exclusive Palliative Care Unit (PCU) with the diagnosis of COVID-19, and to evaluate the factors associated with death in these cases. Design: Retrospective cohort study with data from advanced cancer inpatients to an exclusive PCU, from March to July 2020, with severe acute respiratory syndrome. Diagnostic of COVID-19 and death were the dependent variables. Logistic regression analyses were performed, with the odds ratio (OR) and 95% confidence interval (CI). Results: One hundred fifty-five patients were selected. The mean age was 60.9 (±13.4) years old and the most prevalent tumor type was breast (30.3%). Eighty-three (53.5%) patients had a diagnostic confirmation of COVID-19. Having diabetes mellitus (OR: 2.2; 95% CI: 1.1-6.6) and having received chemotherapy in less than 30 days before admission (OR: 3.8; 95% CI: 1.2-12.2) were associated factors to diagnosis of COVID-19. Among those infected, 81.9% died and, patients with Karnofsky Performance Status (KPS) < 30% (OR: 14.8; 95% CI 2.7-21.6) and C-reactive protein (CRP) >21.6mg/L (OR: 9.3; 95% CI 1.1-27.8), had a greater chance of achieving this outcome. Conclusion: Advanced cancer patients who underwent chemotherapy in less than 30 days before admission and who had diabetes mellitus were more likely to develop Coronavirus 2019 disease. Among the confirmed cases, those hospitalized with worse KPS and bigger CRP were more likely to die.


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