scholarly journals Performance status and trial site-level factors are associated with missing data in palliative care trials: An individual participant-level data analysis of 10 phase 3 trials

2021 ◽  
pp. 026921632110409
Author(s):  
Jamilla A Hussain ◽  
Ian R White ◽  
Miriam J Johnson ◽  
Martin Bland ◽  
David C Currow
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Missing Data ◽  
Primary Outcome ◽  
Performance Status ◽  
Phase 3 ◽  
Level Data ◽  
Individual Participant

Background: Missing data compromise the internal and external validity of trial findings, however there is limited evidence on how best to reduce missing data in palliative care trials. Aim: To assess the association between participant and site level factors and missing data in palliative care trials. Design and setting: Individual participant-level data analysis of 10 phase 3 palliative care trials using multi-level cross-classified models. Results: Participants with missing data at the previous time-point and poorer performance status were more likely to have missing data for the primary outcome and quality of life outcomes, at the primary follow-up point and end of follow-up. At the end of follow-up, the number of site randomisations and number of study site personnel were significantly associated with missing data. Trial duration and the number of research personnel explained most of the variance at the trial and site-level respectively, except for the primary outcome where the amount of data requested was most important at the trial-level. Variance at the trial level was more substantial than at the site level across models and considerable variance remained unexplained for all models except quality of life at the end of follow-up. Conclusion: Participants with a poorer performance status are at higher risk of missing data in palliative care trials and require additional support to provide complete data. Performance status is a potential auxiliary variable for missing data imputation models. Reducing trial variability should be prioritised and further factors need to be identified and explored to explain the residual variance.

scholarly journals Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial

2015 ◽  
Vol 25 (3) ◽  
pp. 235-246 ◽  
Author(s):  
Beate Schrank ◽  
Tamsin Brownell ◽  
Zivile Jakaite ◽  
Charley Larkin ◽  
Francesca Pesola ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Group Intervention ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Esteem ◽  
Positive Psychotherapy ◽  
Main Effect ◽  
Randomised Controlled

Aims.Third-wave psychological interventions have gained relevance in mental health service provision but their application to people with psychosis is in its infancy and interventions targeting wellbeing in psychosis are scarce. This study tested the feasibility and preliminary effectiveness of positive psychotherapy adapted for people with psychosis (WELLFOCUS PPT) to improve wellbeing.Methods.WELLFOCUS PPT was tested as an 11-week group intervention in a convenience sample of people with psychosis in a single centre randomised controlled trial (ISRCTN04199273) involving 94 people with psychosis. Patients were individually randomised in blocks to receive either WELLFOCUS PPT in addition to treatment as usual (TAU), or TAU only. Assessments took place before randomisation and after the therapy. The primary outcome was wellbeing (Warwick-Edinburgh Mental Well-Being Scale, WEMWBS). Secondary outcomes included symptoms (Brief Psychiatric Rating Scale), depression (Short Depression-Happiness Scale), self-esteem, empowerment, hope, sense of coherence, savouring beliefs and functioning, as well as two alternative measures of wellbeing (the Positive Psychotherapy Inventory and Quality of Life). Intention-to-treat analysis was performed. This involved calculating crude changes and paired-sample t-tests for all variables, as well as ANCOVA and Complier Average Causal Effect (CACE) Analysis to estimate the main effect of group on all outcomes.Results.The intervention and trial procedures proved feasible and well accepted. Crude changes between baseline and follow-up showed a significant improvement in the intervention group for wellbeing according to all three concepts assessed (i.e., WEMWBS, Positive Psychotherapy Inventory and Quality of Life), as well as for symptoms, depression, hope, self-esteem and sense of coherence. No significant changes were observed in the control group. ANCOVA showed no main effect on wellbeing according to the primary outcome scale (WEMWBS) but significant effects on symptoms (p = 0.006, ES = 0.42), depression (p = 0.03, ES = 0.38) and wellbeing according to the Positive Psychotherapy Inventory (p = 0.02, ES = 0.30). Secondary analysis adapting for therapy group further improved the results for symptom reduction (p = 0.004, ES = 0.43) and depression (p = 0.03, ES = 0.41) but did not lead to any more outcomes falling below the p = 0.05 significance level. CACE analysis showed a non-significant positive association between the intervention and WEMWBS scores at follow-up (b = 0.21, z = 0.9, p = 0.4).Conclusions.This study provides initial evidence on the feasibility of WELLFOCUS PPT in people with psychosis, positively affecting symptoms and depression. However, more work is needed to optimise its effectiveness. Future research might evaluate positive psychotherapy as a treatment for comorbid depression in psychosis, and consider alternative measurements of wellbeing.

Quality of Life after High Dose Chemotherapy with Autologous Hematopoietic Progenitor Cell Support Long Term Follow-Up.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3331-3331
Author(s):  
Marylou Nesbitt ◽  
Kenneth A. Ault ◽  
Fred Aronson ◽  
Marjorie A. Boyd ◽  
Delvyn Caedren Case ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Performance Status ◽  
Exercise Program ◽  
High Dose Chemotherapy ◽  
Hematopoietic Progenitor Cell ◽  
High Dose ◽  
Cell Support

Abstract Background: High Dose Chemotherapy with Autologous Hematopoietic Progenitor Cell Support (HDC/AutHPCS) is a cancer treatment which provides potential for improved survival and risk for short and long term treatment side effects. Self report of QOL outcomes can guide risk assessment and system improvements to optimize care and rehabilitation. Purpose: This study examined and compared over time, the quality of life outcomes for patients who have undergone this treatment. Design: The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT v.3) was the survey instrument used to measure QOL. Respondents were also asked to report their performance status based on the Eastern Co-operative Oncology Group (ECOG) and the New York Heart Association (NYHA) Performance status scales. Two open-ended questions were asked: what ”Good”, or “Bad” things occurred related to the treatment. Additional questions were asked about sleep problems that occurred after transplant, and whether a structured exercise program would have helped after discharge. Method: A survey was mailed in November, 2005. Sample: Patients (n=145) who had this treatment at our institution were contacted by mail. Diagnoses included acute myeloid leukemia, lymphoma, multiple myeloma, amyloid, breast cancer, and testicular cancer. Data analysis: Scores for the FACT-BMT were analyzed using SPSS 14 (SPSS Inc., Chicago IL). Qualitative responses were analyzed using NVivo v.7 software. Results: The return rate was 57% (n=81). The FACT-BMT Scores, subscales and total scores were comparable to other findings in similar studies and populations. FACT BMT SCORES 2006 FactG Score (Mean+/−SD) Range(0–112) 89.24+/−17.32 (45–112) FACT BMT Score (Mean+/−SD Range (0–40) 29.14+/−6.37 (16–40) FACTG/BMT Total (Mean+/−SD) Range (0–152) 118.29+/−22.78 (61–152) There were no statistically significant differences in scores from past studies with this population at this institution. Significant correlations were found between the scores of items in the FACT-BMT for which ≥ 25% of respondents reported low item ratings and the self rating ECOG and/or NYHA performance scales. Significant differences were also found when comparing the FACT-BMT Scores, subscales and total scores with demographic attributes such as, marital status, living situation, health insurance, employment status, and income. Twenty-five per cent (n=21) of respondents described new problems with sleep and 54% (n= 41) of respondents reported that a structured exercise program would have been beneficial for recovery. There were 21 respondents who participated in this survey (2006) and two prior surveys (1997 and 1999). Content and themes of their unsolicited and solicited written responses of their self reported lived experiences over time will be presented. Conclusions: Overall, participants reported good quality of life. Based on demographics, there were subgroups identified potentially needing assessments and interventions focused on physical, social, emotional, and functional well being. This could be accomplished through a more focused pre-admission and follow-up needs assessment to identify patients who would potentially benefit from additional resources for psychosocial support, sleep and exercise/activity issues.

Pulmonary lymphangitis and cancer: Prospective series of 37 patients in palliative care

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18600-18600 ◽  
Author(s):  
A. A. Dettino ◽  
E. M. Negri ◽  
T. Pagano
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Short Form ◽  
Primary Tumors ◽  
Patients With Cancer ◽  
The Moment ◽  
In The Beginning ◽  
Minor Criteria

18600 Background: Lymphangitis of the lungs is an uncommon type of metastasis, mainly in breast, lung and gastric cancers, and has major impact in quality of life and an unfavorable prognosis. Survival is very poor: 50% in 3 and 15% in 6 months. Our objective was to evaluate prospectively quality of life in cancer patients with pulmonary lymphangitis, under palliative care. Methods: Patients with pulmonary lymphangitis, diagnosed either by lung biopsy (major criteria) or 3 minor criteria (cyto or histotologically proven cancer, clinical picture and image exam) were followed in 3 tertiary services, in a cohort series study. Primary end point was quality of life (QoL), measured with questionnaires in the beginning of the study and monthly afterwards (Saint George Respiratory Questionnaire -SGRQ- and Medical Outcomes Study 36-Item Short-Form Health Survey -SF36). Clinical and complementary aspects were also followed, in addition to treatment and outcome. Results: Thirty-seven patients were included from Aug/2004 to Jan/2006 - 23 female and 14 male; age from 41 to 84 (mean: 62) years. Primary tumors were: lung (20), breast (11), esophagus (2), pancreas, rectum and bone. Of those patients, 33 were able to respond QoL questionnaires in the beginning of follow-up and monthly thereafter. Median follow-up was of one month (range: 0–13); at the moment, 9 patients are still alive. Median survival was 2.5 months (range: 0,1–33), with 38% with a survival of at least 6 months. In general, QoL was poor, but improved after palliative care. Notice that values get higher as QoL improves in SF-36; however, they get lower as QoL improves in SGRQ - values were 61.5, 50.5, 61.7, and 47.5% for SGRQ and 38.1, 32.1, 32.8, 61.6 for SF36 in 0, 1, 3 and 6 months, respectively. Palliative care included: corticosteroids (65%), oxygen (51%), opioids (51%), diuretics (47%), inhalations with beta2-agonists and/or ipatropium (57%), chemo and/or hormonotherapy (51%), physical therapy (43%), antidepressants and benzodiazepines (37% each), thoracocentesis (35%), and blood transfusions. Conclusions: Even though QoL is poor and survival is short for patients with cancer lymphangitis in lungs, some improvement is possible with active palliative care. No significant financial relationships to disclose.

Moving palliative care upstream for patients diagnosed with head and neck cancers.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 227-227
Author(s):  
Tamara M Day
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Head And Neck ◽  
Symptom Burden ◽  
Psychosocial Distress ◽  
Head And Neck Cancers ◽  
Improve Quality ◽  
Convenience Sample

227 Background: Adults with cancer face complex treatment choices and symptom burden that impact their quality of life. Goals of palliative care (PC) are to reduce symptom burden and improve quality of life. Strong evidence exists that PC helps reduce symptom burden, decreases hospital utilization, and improve quality of life. Yet, PC remains underutilized, especially in the context of cancer care. Methods: This descriptive longitudinal study evaluated whether use of a psychosocial distress screening tool would help identify patients eligible for PC. A convenience sample of adults with diagnosis of head and neck cancers presenting to an otolaryngology clinic, located in the cancer center of a Midwestern academic health system, were screened for eligibility for PC referral. If eligible, the provider was notified and introduced PC to the patient. Upon acceptance, a PC referral was ordered. The project consisted of baseline (n = 61) and follow-up chart reviews (n = 60) of patients seen in clinic during over a 3-month period. Results: We found an increase in PC referrals from 14.6% at baseline to 30.8% in follow-up, a 227% increase. Psychosocial distress screenings increased from 5% at baseline to 45% in follow-up, an increase of 200%. Of patients who received a PC referral, 85.6% accepted. There were statistically significant differences found between the pre- and post-intervention groups for marital status, χ2 (3) = 9.67, ( p = .02); and cancer stage χ2 (4) = 21.35, ( p = .00) with increased referrals for married patients at higher cancer stages in the prospective group. Conclusions: This study has shown physicians maybe more likely to offer PC referrals based on cancer stages, and not based on psychosocial distress symptoms. Potential barriers to early referral to PC were identified and could serve as useful information for future studies.

scholarly journals Outcomes following lymphaticovenous anastomosis (LVA) for 100 cases of lymphedema: results over 24-months follow-up

2020 ◽  
Vol 184 (1) ◽  
pp. 173-183
Author(s):  
Shan S. Qiu ◽  
Tim Pruimboom ◽  
Anouk J. M. Cornelissen ◽  
Rutger M. Schols ◽  
Sander M. J. van Kuijk ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lower Extremity ◽  
Upper Extremity ◽  
Primary Outcome ◽  
Lymphatic Drainage ◽  
Long Term Outcomes ◽  
Compression Garments

Abstract Purpose Lymphedema is a debilitating condition that significantly affects patient’s quality of life (QoL). The aim of this study was to assess the long-term outcomes after lymphaticovenous anastomosis (LVA) for extremity lymphedema. Methods A single-center prospective study on upper and lower extremity lymphedema patients was performed. All LVA procedures were preceded by outpatient Indocyanine Green (ICG) lymphography. Quality of life measured by the Lymph-ICF was the primary outcome. Limb circumference, use of compression garments, and frequency of cellulitis episodes and manual lymphatic drainage (MLD) sessions were secondary outcomes. Results One hundred consecutive patients, predominantly experiencing upper extremity lymphedema following breast cancer (n = 85), underwent a total of 132 LVAs. During a mean follow-up of 25 months, mean Lymph-ICF score significantly decreased from 43.9 preoperative to 30.6 postoperative, representing significant QoL improvement. Decrease in upper and lower limb circumference was observed in 52% of patients with a mean decrease of 6%. Overall mean circumference was not significantly different. Percentage of patients that could reduce compression garments in the upper and lower extremity group was 65% and 40%, respectively. Number of cellulitis episodes per year and MLD sessions per week showed a mean decrease of respectively 0.6 and 0.8 in the upper extremity and 0.4 and 1.0 in the lower extremity group. Conclusions LVA resulted in significant QoL improvement in upper and lower extremity lymphedema patients. Limb circumference did not significantly improve but good results concerning compression garments, cellulitis episodes, and MLD sessions were obtained. Additionally, a simple and patient-friendly method for outpatient ICG lymphography is presented.

scholarly journals Therapist-Guided Internet-Based Treatments for Loneliness: A Randomized Controlled Three-Arm Trial Comparing Cognitive Behavioral Therapy and Interpersonal Psychotherapy

2021 ◽  
pp. 1-8
Author(s):  
Anton Käll ◽  
Malin Bäck ◽  
Camilla Welin ◽  
Hanna Åman ◽  
Rasmus Bjerkander ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cognitive Behavioral Therapy ◽  
Primary Outcome ◽  
Behavioral Therapy ◽  
Interpersonal Psychotherapy ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Wait List

<b><i>Introduction:</i></b> Chronic loneliness has been linked to many adverse outcomes, including mental health problems. Psychological treatment of loneliness can be effective, but the evidence base is limited. <b><i>Objective:</i></b> To investigate the efficacy of 2 internet-based interventions based on cognitive behavioral therapy (ICBT) and interpersonal psychotherapy (IIPT) relative to a wait-list control group and each other. <b><i>Methods:</i></b> A total of 170 participants were recruited and randomized to either 9 weeks of ICBT (<i>n</i> = 68), IIPT (<i>n</i> = 68), or a wait-list condition (<i>n</i> = 34). The primary outcome was loneliness, measured using the UCLA Loneliness Scale before, during, and after treatment. Secondary measures of psychiatric disorders and quality of life were administered before and after treatment. Follow-up was conducted 4 months after the treatment had ended. Primary outcome data were analyzed using growth curve modeling. Secondary outcomes were analyzed using robust regression models. The trial was preregistered (ClinicalTrials.gov ID: NCT03807154). <b><i>Results:</i></b> The ICBT condition had a significantly greater impact on loneliness compared to the wait-list and IIPT conditions. Effect sizes were moderate to large (Cohen <i>d</i> = 0.71) compared to the wait-list and moderate (<i>d</i> = 0.53) compared to IIPT. The IIPT condition did not differ significantly from the wait-list. Both active treatments led to significant increases in quality of life. Only the ICBT group had significantly lower symptoms of depression and generalized anxiety compared to the wait-list group. Treatment gains were maintained but not improved at follow-up. <b><i>Conclusions:</i></b> ICBT can be an efficacious option for alleviating loneliness. The IIPT intervention was not as effective.

scholarly journals Shifting palliative care paradigm in primary care from better death to better end-of-life: a Swiss pilot study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Johanna Sommer ◽  
Christopher Chung ◽  
Dagmar M. Haller ◽  
Sophie Pautex
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Palliative Care ◽  
Pilot Study ◽  
End Of Life ◽  
Advanced Cancer ◽  
Communication Skills ◽  
Advanced Cancer Patients

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.

scholarly journals Quantification of quality of life improvement after appropriate symptoms control in cancer patients with breakthrough pain: A four-week follow-up study in a palliative care unit

2019 ◽  
Vol 19 (4) ◽  
Author(s):  
Miguel Ángel Núñez Viejo ◽  
Carmen Areses Manrique ◽  
Leticia Iglesias Rey ◽  
Antonio Iglesias Rey ◽  
Antonio Javier Jiménez López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Cancer Patients ◽  
Breakthrough Pain ◽  
Palliative Care Unit ◽  
Follow Up Study ◽  
Life Improvement

Validity and utility of the University of Texas M. D. Anderson Symptom Inventory (MDASI) among prostate cancer patients: Data from E2Z02: Symptom Outcomes and Practice Patterns (SOAPP).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15173-e15173
Author(s):  
Linda J. Patrick-Miller ◽  
Fengmin Zhao ◽  
Charles S. Cleeland ◽  
Lynne I. Wagner ◽  
Michael Fisch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Medical Oncology ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Symptom Assessment ◽  
Severe Nausea ◽  
Patient Reported

e15173 Background: Optimal treatment outcomes for patients (pts) with prostate cancer are dependent upon rigorous symptom assessment. The MDSAI, a patient-reported outcome measure of symptoms (sxs) and their impact validated in a sample of patients of diverse cancer types has the potential to inform symptom experience and guide treatment specific to prostate cancer pts. Methods: SOAPP, an Eastern Cooperative Oncology Group (ECOG) study, was conducted at academic and community medical oncology clinics and included pts with prostate cancer of all stages and phases of care. At baseline and 4 weeks, pts completed a measure of symptom severity and functional interference (MDASI). Symptom experiences and psychometric properties of the MDASI in prostate cancer pts (n = 320) were analyzed. Results: The 5 most prevalent moderate/severe sxs reported at baseline were fatigue (34%), disturbed sleep (25%), drowsiness (18%), pain (17%), and dry mouth (15%); moderate/severe nausea (5%) and vomiting (2%) were the least prevalent. At baseline ECOG performance status (PS) was ≥2 in 9% of pts. Pain, sadness, and difficulty remembering things occurred in 17%, 14%, and 13% respectively, and among pts whose PS worsened, severity of these sxs had the highest change scores at follow-up. Internal consistency and test-retest reliability of the MDASI were good, with Cronbach coefficient alphas ≥0.84 and intra-class correlations ≥0.78 for all subscales. Significantly higher scores and moderately large effects for the MDASI severity scale were reported by pts with poorer PS (2.2 vs 1.0, ES=.83) and tumor progression (2.4 vs 1.2, ES=.73) p<.05. Results were similar for the interference scale, demonstrating MDASI known-group validity. Pts whose quality of life declined showed significantly greater increase in severity (1.1 vs .14, p<.01) and interference (1.9 vs .28, p<.004) from baseline to follow-up than pts whose quality of life was unchanged, demonstrating MDASI sensitivity to change. Conclusions: The MDASI is a valid, reliable, and sensitive symptom assessment method for descriptive and clinical studies, and patient care in medical oncology outpatients with prostate cancer.

Sign in / Sign up

Export Citation Format

Share Document