scholarly journals Prevalence of adjustment disorder among cancer patients, and the reach, effectiveness, cost-utility and budget impact of tailored psychological treatment: study protocol of a randomized controlled trial

2019 ◽  
Vol 7 (1) ◽  
Author(s):  
Florie E. van Beek ◽  
Lonneke M. A. Wijnhoven ◽  
Femke Jansen ◽  
José A. E. Custers ◽  
Eline J. Aukema ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Budget Impact ◽  
Psychological Intervention ◽  
Psychological Treatment ◽  
Controlled Trial ◽  
Adjustment Disorder ◽  
Cost Utility ◽  
Adjustment Disorders ◽  
Randomized Controlled

Abstract Background Information on the prevalence of adjustment disorders among cancer patients and the value of psychological interventions in this group of patients is limited. This study investigates the prevalence of adjustment disorders among cancer patients as well as the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. Method This study consists of two parts. Part 1 is an observational study among a representative group of mixed cancer patients after cancer treatment on the prevalence of adjustment disorder as well as the uptake (i.e. reach) of psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial. Patients will be randomized to the intervention (access to the tailored psychological intervention) or control group (waitlist period of 6 months). The psychological intervention consists of three modules: one module containing psycho-education (3 sessions, all patients) and two additional modules (maximum of 6 sessions per module) provided as continuum, in case needed. Module 2 and 3 can consist of several evidence-based interventions (e.g. group interventions, mindfulness, eHealth) The primary outcome is psychological distress (HADS). Secondary outcomes are mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). To assess the cost-utility and budget impact, quality of life (EQ-5D-5 L) and costs (iMCQ and iPCQ) will be measured. Measures will be completed at baseline and 3 and 6-months after randomization. Discussion This study will provide data of the prevalence of adjustment disorders and the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. Trial registration Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.

Effect of medical Qigong on cognitive function, quality of life, and a biomarker of inflammation in cancer patients: a randomized controlled trial

2011 ◽  
Vol 20 (6) ◽  
pp. 1235-1242 ◽  
Author(s):  
Byeongsang Oh ◽  
Phyllis N. Butow ◽  
Barbara A. Mullan ◽  
Stephen J. Clarke ◽  
Philip J. Beale ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cognitive Function ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals A Randomized Controlled Trial of the Effects of Transcendental Meditation on Quality of Life in Older Breast Cancer Patients

2009 ◽  
Vol 8 (3) ◽  
pp. 228-234 ◽  
Author(s):  
Sanford I. Nidich ◽  
Jeremy Z. Fields ◽  
Maxwell V. Rainforth ◽  
Rhoda Pomerantz ◽  
David Cella ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Transcendental Meditation ◽  
Controlled Trial ◽  
Breast Cancer Patients ◽  
Randomized Controlled

scholarly journals Patient Empowerment Improved Perioperative Quality of Care in Cancer Patients Aged ≥ 65 Years – A Randomized Controlled Trial

PLoS ONE ◽  
2015 ◽  
Vol 10 (9) ◽  
pp. e0137824 ◽  
Author(s):  
Maren Schmidt ◽  
Rahel Eckardt ◽  
Kathrin Scholtz ◽  
Bruno Neuner ◽  
Vera von Dossow-Hanfstingl ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Quality Of Care ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Patient Empowerment ◽  
Randomized Controlled

Intensive versus minimalist follow-up in patients treated for endometrial cancer: A multicentric randomized controlled trial (The TOTEM study—NCT00916708).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5506-5506
Author(s):  
Paolo Zola ◽  
Giovannino Ciccone ◽  
Elisa Piovano ◽  
Luca Fuso ◽  
Elena Peirano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Endometrial Cancer ◽  
Cancer Patients ◽  
Early Recognition ◽  
Controlled Trial ◽  
Physical And Mental Health ◽  
Randomized Controlled

5506 Background: Intensive follow-up in cancer patients, which absorbs a lot of health system resources and can be a source of increased stress for patients, are often proposed on the assumption that an early recognition of relapse will translate in better outcomes. In endometrial cancer few randomized controlled trials were conducted to assess the role of a reduced number of the scheduled visits and of different settings of the follow-up, but did not investigate the contribution of routine serum, cytological or imaging follow-up investigations in improving overall survival or quality of life. The TOTEM study was planned to compare an intensive (INT) vs minimalist (MIN) 5- year follow-up regimen in endometrial cancer patients in terms of overall survival (OS). Methods: Patients surgically treated for endometrial cancer, in complete clinical remission confirmed by imaging, FIGO stage I-IV, were stratified by center and in low (LoR) or high (HiR) risk of recurrence and then randomized to INT or MIN hospital-based follow-up regimens. The main study hypothesis was to demonstrate an improvement from 75% to 80% (expected hazard ratio, HR = 0.78) of the 5-year OS with the INT regimen. Secondary objectives were to compare relapse free survival (RFS), health-related quality of life (HRQL) assessed at baseline, at 6 and 12 months and then yearly (with the SF-12 Physical and Mental Health Summary Scale) and costs. Results: 1884 patients were randomized in 42 centers between 2008 and 2018, and 1847 patients were available for the final analysis (60% LoR). Compliance with the follow-up scheduled visits was 75.3%, similar between INT (74.7%) and MIN (75.9%) arms, whereas the mean number of recorded exams (laboratory or imaging) was markedly higher in the INT than in the MIN arms (9.7 vs 2.9, p < 0.0001). After a median follow-up of 66 months, the overall 5-year OS was 91.3%, 90.6% in the INT and 91.9% in the MIN arms, respectively (HR = 1.12, 95%CI 0.85-1.48, p = 0.429). Comparing the INT vs MIN arms, the 5-year OS were 94.1% and 96.8% (HR = 1.48, 0.92-2.37, p = 0.104) in the LoR and 85.3% and 84.7% (HR = 0.96, 0.68-1.36, p = 0.814) in the HiR group. No relevant differences emerged in RFS between INT and MIN regimens, (HR = 1.13, 0.87-1.48, p = 0.365). At the time of the relapse most women were asymptomatic (146/228, 64.0%), with a tendency of higher proportions in the INT than in the MIN arm, both in the LoR group (78.8% vs 61.1%, p = 0.070) and in the HiR one (64% vs 60%, p = 0.754). HRQL was available only for a subgroup of patients (50% at baseline) and did not differ between arms. Conclusions: Intensive follow-up in endometrial cancer treated patients showed a weak and uncertain advantage in detecting earlier asymptomatic relapses but did not improve OS, even in HiR patients, nor influenced HRQL. Frequent routine use of imaging and laboratory exams in these patients should be discouraged. Clinical trial information: NCT00916708.

scholarly journals Efficacy of Expressive Helping in Adult Hematologic Cancer Patients Undergoing Stem Cell Transplant: Protocol for the Writing for Insight, Strength, and Ease (WISE) Study’s Two-Arm Randomized Controlled Trial.

2021 ◽  
Author(s):  
Lauren A Whitmore ◽  
Taylor Schulte ◽  
Katrin Bovbjerg ◽  
Madison Hartstein ◽  
Jane Austin ◽  
...  
Keyword(s):  
Stem Cell ◽  
Cancer Patients ◽  
Stem Cell Transplant ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Cell Transplant ◽  
Hematopoietic Stem ◽  
Randomized Controlled ◽  
Related Quality

Abstract Background: During, shortly after, and sometimes for years after hematopoietic stem cell transplant, a large proportion of hematological cancer patients undergoing transplant report significant physical and psychological symptoms and reduced health-related quality of life. To address these survivorship problems, we developed a low-burden, brief psychological intervention called expressive helping that includes two theory- and evidence-based components designed to work together synergistically: emotionally expressive writing and peer support writing. Building on evidence from a prior randomized control trial showing reductions in physical symptoms and distress in long-term transplant survivors with persistent survivorship problems, the Writing for Insight, Strength, and Ease (WISE) trial will evaluate the efficacy of expressive helping when used during transplant and in the early post-transplant period, when symptoms peak and when intervention could prevent development of persistent symptoms.Methods: WISE is a multi-site, two-arm randomized controlled efficacy trial. Adult hematological cancer patients scheduled for a hematopoietic stem cell transplant will complete baseline measures and then, after hospitalization but prior to transplant, they will be randomized to complete either expressive helping or a time and attention “neutral writing” task. Both expressive helping and neutral writing involve four brief writing sessions, beginning immediately after randomization and ending approximately four weeks after hospital discharge. Measures of symptom burden (primary outcome), distress, health-related quality of life, and fatigue (secondary outcomes) will be administered in seven assessments coinciding with medically relevant time points from baseline and to a year post-intervention. Discussion: The steady and continuing increase in use of stem cell transplantation has created growing need for efficacious, accessible interventions to reduce the short- and long-term negative physical and psychosocial effects of this challenging but potentially life-saving treatment. Expressive helping is a psychological intervention that was designed to fill this gap. It has been shown to be efficacious in long-term transplant survivors, but could have even greater impact if it is capable of reducing symptoms during and soon after transplant. The WISE study will evaluate these benefits in a rigorous randomized controlled trial. Trial registration: Clinicaltrial.gov: NCT03800758. Expressive Helping for Stem Cell Transplant Patients, registered January 11, 2019. https://www.clinicaltrials.gov/ct2/show/NCT03800758?term=expressive+helping&draw=2&rank=2

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