The development of a brief 5-minute mindful breathing therapy for the reduction of distress in palliative cancer patients

2017 ◽  
Vol 41 (S1) ◽  
pp. s499-s499
Author(s):  
C.G. Ng ◽  
S.B. Tan ◽  
K.T. Lai ◽  
N.Z. Zainal ◽  
A.H. Sulaiman ◽  
...  
Keyword(s):  
Palliative Care ◽  
Cancer Patients ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Skin Surface ◽  
Phase Iii ◽  
Pilot Test ◽  
Rapid Reduction ◽  
Breathing Therapy ◽  
Competing Interest

IntroductionAlthough psychological distress is highly prevalent, palliative cancer patients are mostly too lethargic to undergo many sessions of the conventional psychotherapy.ObjectivesThe study aims to develop a brief, quick and easy to administer psychological intervention for rapid reduction of distress in palliative care patients.MethodsIn phase I, an expert panel of multidisciplinary team was formed. The theory of mindfulness-based intervention was simplified into a 5-minute mindful breathing technique that can be learnt and practiced by palliative care patients.In phase II, the efficacy of 5-minute mindful breathing was investigated in a pilot test that comprised of nine palliative cancer patients and eleven care takers.In Phase III, the efficacy of 5-minute mindful breathing was further examined in a non-blinded, randomized controlled trial (RCT) that included 60 cancer patients under palliative care. Apart from perceived distress, physiological measures were assessed.ResultsThe effect of 5-minute mindful breathing in rapidly reducing distress among palliative care patients was confirmed in both the pilot test (Tan et al., 2015) and RCT (Ng et al., 2016). The finding was further supported by the significant physiological changes associated with distress reduction such as decreased breathing rate, blood pressure, pulse rate, galvanic skin and increased skin surface temperature (Ng et al., 2016) with the 5-minute mindful breathing.ConclusionThe 5-minute mindful breathing is a quick and easy to administer intervention that is useful for reducing acute suffering or distress in palliative care patients.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Onur M. Orun ◽  
Myrick C. Shinall ◽  
Aimee Hoskins ◽  
Ellis Morgan ◽  
Mohana Karlekar ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Specialist Palliative Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Scope Trial

Abstract Background The impact of specialist palliative care intervention in patients undergoing surgery for cancer has not been studied extensively. The SCOPE randomized controlled trial will investigate the effect of specialist palliative care intervention in cancer patients undergoing surgery for selected abdominal malignancies. The study protocol of the SCOPE Trial was published in December 2019. Methods and design The SCOPE Trial is a single-center, single-blind, prospective, randomized controlled trial that will investigate specialist palliative care intervention for cancer patients undergoing surgery for selected abdominal malignancies. The study plans to enroll 236 patients that will be randomized to specialist palliative care (intervention arm) and usual care (control arm) in a 1:1 ratio. Results The primary outcome of the study is the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI) at 90 days postoperatively. Secondary outcomes of the study include the total FACT-G score at 90 days postoperatively, days alive at home without an emergency room visit within 90 days of operation, and all-cause mortality at 1 year after operation. Time frames for all outcomes will start on the day of surgery. Conclusion This manuscript serves as the formal statistical analysis plan (version 1.0) for the SCOPE randomized controlled trial. The statistical analysis plan was completed on 6 April 2021. Trial registration ClinicalTrials.gov NCT03436290. Registered on 16 February 2018

scholarly journals Effect of home-based specialised palliative care and dyadic psychological intervention on caregiver anxiety and depression: a randomised controlled trial

2018 ◽  
Vol 119 (11) ◽  
pp. 1307-1315 ◽  
Author(s):  
Annika von Heymann-Horan ◽  
Pernille Bidstrup ◽  
Mai-Britt Guldin ◽  
Per Sjøgren ◽  
Elisabeth Anne Wreford Andersen ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Anxiety And Depression ◽  
Home Based ◽  
Randomised Controlled ◽  
Caregiver Anxiety

scholarly journals Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia

2020 ◽  
Vol 18 ◽  
pp. 100564
Author(s):  
Eleanor Reid ◽  
Ephrem Abathun ◽  
Jilcha Diribi ◽  
Yoseph Mamo ◽  
Peter Hall ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Study Design ◽  
Addis Ababa ◽  
Controlled Trial ◽  
Newly Diagnosed ◽  
Early Palliative Care ◽  
Randomized Controlled

scholarly journals The efficacy of specialised rehabilitation using the Op-reha Guide for cancer patients in palliative care units: protocol of a multicentre, randomised controlled trial (JORTC-RHB02)

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Nanako Nishiyama ◽  
Yoshinobu Matsuda ◽  
Noriko Fujiwara ◽  
Keisuke Ariyoshi ◽  
Shunsuke Oyamada ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Cancer Patients ◽  
Group Performance ◽  
Controlled Trial ◽  
Care Group ◽  
Terminal Cancer ◽  
Terminal Cancer Patients ◽  
Palliative Care Units ◽  
Randomised Controlled

Abstract Background Although rehabilitation is recommended for terminal cancer patients, the specific components and methods of such programs are poorly documented. No studies to date have examined the effectiveness of rehabilitation for terminal cancer patients. This study aims to evaluate the efficacy of a new intervention for rehabilitation therapists, using the Op-reha Guide (Guide to Optimal and Patient-Centred Rehabilitation Practice for Patients in Palliative Care Units [PCUs]) in rehabilitation practice. This guide consists of recommended actions and attitudes for rehabilitation therapists and aims to optimise therapists’ actions according to the patient’s needs and condition. It shares goals with terminal cancer patients to maintain their activities of daily living (ADL). Methods This study uses a multicentre, prospective, randomised controlled trial (RCT) design with two parallel groups in PCUs where specialised rehabilitation will be routinely performed for terminal cancer patients by rehabilitation therapists. Participants will be randomised (1:1) to intervention (the Op-reha Guide) and control groups (usual rehabilitation). We will then conduct an observational study in PCUs that do not perform specialised rehabilitation for terminal cancer patients; this will be considered the usual care group, and the efficacy of usual rehabilitation will be quantitatively evaluated. Inclusion criteria are hospitalisation in PCU, European Cooperative Oncology Group Performance Status of 2 or 3, and clinical estimation of life expectancy of 3 weeks or more. Patients with severe symptom burden will be excluded. We hypothesise that the Op-reha Guide will be more effective in maintaining the ADL of terminal cancer patients hospitalised in PCUs than usual rehabilitation. The primary endpoint is defined as the change in (total) modified Barthel Index from baseline to Day 22. Quality of life will be a secondary endpoint. In total, 135 patients will be recruited from 16 Japanese sites between July 2019 and December 2021. Discussion This will be the first trial to evaluate the efficacy of specialised rehabilitation for terminal cancer patients hospitalised in PCUs, and will contribute to the evidence on the efficacy of implementing rehabilitation for terminal cancer patients. Trial registration UMIN-CTR, UMIN000037298 R000042525 (date of registration 7 July 2019).

scholarly journals Complementary music therapy for cancer patients in at-home palliative care and their caregivers: protocol for a multicentre randomised controlled trial

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Inmaculada Valero-Cantero ◽  
Francisco Javier Martínez-Valero ◽  
Milagrosa Espinar-Toledo ◽  
Cristina Casals ◽  
Francisco Javier Barón-López ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Music Therapy ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Randomised Controlled ◽  
At Home

VICTOR: A phase III placebo-controlled trial of rofecoxib in colorectal cancer patients following surgical resection

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 4038-4038 ◽  
Author(s):  
D. J. Kerr ◽  
J. A. Dunn ◽  
M. J. Langman ◽  
J. L. Smith ◽  
R. S. Midgley ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Surgical Resection ◽  
Controlled Trial ◽  
Phase Iii ◽  
Colorectal Cancer Patients

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

Sign in / Sign up

Export Citation Format

Share Document