scholarly journals Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial

2017 ◽  
Vol 31 (9) ◽  
pp. 814-824 ◽  
Author(s):  
Mogens Groenvold ◽  
Morten Aagaard Petersen ◽  
Anette Damkier ◽  
Mette Asbjoern Neergaard ◽  
Jan Bjoern Nielsen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Palliative Care ◽  
Advanced Cancer ◽  
Standard Care ◽  
Primary Outcome ◽  
Randomised Clinical Trial ◽  
Sensitivity Analyses ◽  
Specialist Palliative Care ◽  
Beneficial Effects ◽  
Secondary Outcomes

Background: Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal. Aim: To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments. Setting/participants: The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient’s primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0–100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival. Results: Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (−4.9 points (95% confidence interval −11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect. Conclusion: We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.

Binocular game versus part-time patching for treatment of anisometropic amblyopia in Chinese children: a randomised clinical trial

2019 ◽  
Vol 104 (3) ◽  
pp. 369-375
Author(s):  
Jing Yao ◽  
Hye-Won Moon ◽  
Xiaomei Qu
Keyword(s):  
Clinical Trial ◽  
Primary Outcome ◽  
Randomised Clinical Trial ◽  
Chinese Children ◽  
Interocular Suppression ◽  
Anisometropic Amblyopia ◽  
Minimum Angle ◽  
Part Time ◽  
Secondary Outcomes ◽  
The Difference

AimsTo compare amblyopic-eye visual acuity (VA) and binocularity improvement of a binocular game with part-time patching in the treatment of Chinese children with anisometropic amblyopia.Methods103 Chinese children aged 3–13 years with anisometropic amblyopia were recruited in a randomised clinical trial. Eligible participants were randomly assigned to the binocular, patching and combined groups. Primary outcome was amblyopic-eye VA improvement at 3 months. Secondary outcomes included reduction of suppression and change of stereoacuity.ResultsOf 85 completed participants, 44 (52%) were women and mean (SD) age was 5.99 (2.33) years. At 3 months, mean (95% CI) amblyopic-eye VA improved 0.18 (0.10–0.26), 0.28 (0.19–0.36) and 0.30 (0.21–0.39) logarithm of the minimum angle of resolution in the binocular, patching and combined groups, respectively. After adjusting for baseline VA, the difference was statistically significant (F=6.29, p=0.003), favouring as follows: the combined group, the patching group and the binocular group. After treatment, Titmus (x2binocular=9.75, p=0.007; x2combined=9.35, p=0.009) and dynamic stereoacuity (x2binocular=12.56, p=0.01; x2combined=12.66, p=0.01) improved only in the binocular and combined groups. Among groups, only Titmus improvement differed significantly (F=49.55, p<0.001). Changes of other types of stereoacuity and interocular suppression were similar.ConclusionsThe binocular game used in this study could improve amblyopic-eye VA and binocularity in Chinese children with anisometropic amblyopia, but it was less effective than patching in amblyopic-eye VA improvement and showed no superiority in binocularity over patching. It remains unclear whether the low treatment response of this binocular game was due to limitations of the study or its low treatment effect.

scholarly journals The effect of weekly specialist palliative care teleconsultations in patients with advanced cancer –a randomized clinical trial

BMC Medicine ◽  
2017 ◽  
Vol 15 (1) ◽  
Author(s):  
Patrick D. Hoek ◽  
Henk J. Schers ◽  
Ewald M. Bronkhorst ◽  
Kris C. P. Vissers ◽  
Jeroen G. J. Hasselaar
Keyword(s):  
Clinical Trial ◽  
Palliative Care ◽  
Randomized Clinical Trial ◽  
Advanced Cancer ◽  
Specialist Palliative Care

A single-center randomized clinical trial of palliative rehabilitation versus standard care alone in patients with newly diagnosed non-resectable cancer.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 75-75 ◽  
Author(s):  
Lise Nottelmann ◽  
Mogens Groenvold ◽  
Morten Aagard Petersen ◽  
Tove Vejlgaard ◽  
Lars Henrik Jensen
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Palliative Care ◽  
Standard Care ◽  
Primary Outcome ◽  
Absolute Difference ◽  
Group Program ◽  
Rehabilitation Intervention ◽  
Oncology Care

75 Background: Palliative care and rehabilitation may both improve quality of life, but research on their combination and early integration into oncology care is sparse. Methods: Adults diagnosed with non-resectable cancers within the last 8 weeks were randomized to standard oncology care alone or an additional offer of individually tailored palliative rehabilitation. Two mandatory consultations and a 12 week open contact with a specialized palliative care team were offered. An additional opportunity was participation in a multidisciplinary group program combining a patient/caregiver school with physical exercise, individual consultations, or both. Participants were assessed at baseline and after 6 and 12 weeks with an extended version of the EORTC QLQ-C30 questionnaire using the item banks for computer-adaptive testing to obtain improved measurement. At baseline participants were asked to choose what they needed help with the most from a list of possible 'primary problems' corresponding to 12 of the 15 QLQ-C30 scales. The primary outcome was the change in that "primary problem" scale measured as area under the curve across the 12 weeks. Group differences were tested in an adjusted linear regression model. Results: 301 patients with lung- (40%), gastrointestinal- (27%), prostatic- (18%), and various other solid tumors (15%) were included. 139 patients were allocated to the intervention group and 149 to the standard care group. The palliative rehabilitation intervention was received by 132. Of those, 26 received the two mandatory consultations only, 59 additionally participated in a group program, and 47 additionally received individual consultations without participation in a group. The intervention showed an effect for the primary outcome with an absolute between-group difference of 3.0 (0.0;6.0) p = 0.047. The result was confirmed by a sensitivity analysis of the change from baseline to 12 weeks showing an absolute difference of 3.3 (1.0; 5.6) p = 0.005. Conclusions: A palliative rehabilitation intervention initiated soon after diagnosis and integrated in the standard oncology treatment improved quality of life. Clinical trial information: NCT02332317.

scholarly journals In-Patient Treatment of Fibromyalgia: A Controlled Nonrandomized Comparison of Conventional Medicine versus Integrative Medicine including Fasting Therapy

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Andreas Michalsen ◽  
Chenying Li ◽  
Katharina Kaiser ◽  
Rainer Lüdtke ◽  
Larissa Meier ◽  
...  
Keyword(s):  
Integrative Medicine ◽  
Multimodal Treatment ◽  
Primary Outcome ◽  
Conventional Medicine ◽  
Fibromyalgia Impact Questionnaire ◽  
Treatment Strategies ◽  
Well Being ◽  
Patient Treatment ◽  
Beneficial Effects ◽  
Secondary Outcomes

Fibromyalgia poses a challenge for therapy. Recent guidelines suggest that fibromyalgia should be treated within a multidisciplinary therapy approach. No data are available that evaluated multimodal treatment strategies of Integrative Medicine (IM). We conducted a controlled, nonrandomized pilot study that compared two inpatient treatment strategies, an IM approach that included fasting therapy and a conventional rheumatology (CM) approach. IM used fasting cure and Mind-Body-Medicine as specific methods. Of 48 included consecutive patients, 28 were treated with IM, 20 with CM. Primary outcome was change in the Fibromyalgia Impact Questionnaire (FIQ) score after the 2-week hospital stay. Secondary outcomes included scores of pain, depression, anxiety, and well being. Assessments were repeated after 12 weeks. At 2 weeks, there were significant improvements in the FIQ (P<0.014) and for most of secondary outcomes for the IM group compared to the CM group. The beneficial effects for the IM approach were reduced after 12 weeks and no longer statistically significant with the exception of anxiety. Findings indicate that a multimodal IM treatment with fasting therapy might be superior to CM in the short term and not inferior in the mid term. Longer-term studies are warranted to assess the clinical impact of integrative multimodal treatment in fibromyalgia.

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