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

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).

Download Full-text

Does hospital at home for palliative care facilitate death at home? Randomised controlled trial

BMJ ◽

10.1136/bmj.319.7223.1472 ◽

1999 ◽

Vol 319 (7223) ◽

pp. 1472-1475 ◽

Cited By ~ 80

Author(s):

G. E Grande ◽

C. J Todd ◽

S. I G Barclay ◽

M. C Farquhar

Keyword(s):

Palliative Care ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Hospital At Home ◽

Randomised Controlled ◽

At Home

Download Full-text

Faculty Opinions recommendation of Effects of a transitional palliative care model on patients with end-stage heart failure: a randomised controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.726213930.793517382 ◽

2016 ◽

Author(s):

Janet Abrahm

Keyword(s):

Heart Failure ◽

Palliative Care ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Care Model ◽

End Stage Heart Failure ◽

Randomised Controlled ◽

End Stage

Download Full-text

Early Interdisciplinary Palliative Care in Patients with Previously Untreated Metastatic Oesophagogastric Cancer: A Phase 3 Randomised Controlled Trial

SSRN Electronic Journal ◽

10.2139/ssrn.3582831 ◽

2020 ◽

Author(s):

Zhihao Lu ◽

Yu Fang ◽

Chang Liu ◽

Xiaotian Zhang ◽

Xiaowei Xin ◽

...

Keyword(s):

Palliative Care ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Phase 3 ◽

Randomised Controlled ◽

Oesophagogastric Cancer

Download Full-text

Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

BMJ Open ◽

10.1136/bmjopen-2018-025692 ◽

2019 ◽

Vol 9 (1) ◽

pp. e025692 ◽

Cited By ~ 3

Author(s):

Corita R Grudzen ◽

Deborah J Shim ◽

Abigail M Schmucker ◽

Jeanne Cho ◽

Keith S Goldfeld

Keyword(s):

Quality Of Life ◽

Older Adults ◽

Palliative Care ◽

Randomised Controlled Trial ◽

Case Management ◽

Controlled Trial ◽

Chronic Obstructive ◽

Randomised Controlled ◽

End Stage

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03325985; Pre-results.

Download Full-text

Design and evaluation of a theory-based intervention of knowledge and perceptions to improve self-care amongst relatives of esophageal cancer patients: A randomised controlled trial study protocol

International Journal of Surgery Protocols ◽

10.1016/j.isjp.2020.09.001 ◽

2020 ◽

Vol 24 ◽

pp. 12-16

Author(s):

Sakineh Gerayllo ◽

Mohammad Ali Morowatisharifabad ◽

Leila Jouybari ◽

Zohreh Karimiankakolaki ◽

Reza Sadeghi

Keyword(s):

Esophageal Cancer ◽

Randomised Controlled Trial ◽

Cancer Patients ◽

Study Protocol ◽

Controlled Trial ◽

Self Care ◽

Randomised Controlled

Download Full-text

PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽

10.1136/bmjopen-2021-050582 ◽

2021 ◽

Vol 11 (6) ◽

pp. e050582

Author(s):

Annette Mollerup ◽

Sofus Christian Larsen ◽

Anita Selmer Bennetzen ◽

Marius Henriksen ◽

Mette Kildevaeld Simonsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Hospital Admission ◽

Usual Care ◽

Pulmonary Disease ◽

Controlled Trial ◽

Self Care ◽

Secondary Outcome ◽

Link Type ◽

Randomised Controlled ◽

At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

Download Full-text