A Randomized Study of Early Palliative Care
Ontology highlight
ABSTRACT:
DISEASE(S): Palliative Care
PROVIDER: 2179858 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:In this trial, patients with cancer in the upper gastrointestinal canal who are going to receive first line palliative chemotherapy and patients with colorectal cancer who are going to receive second line palliative chemotherapy will be included. Participating patients will be randomized between early contact with a palliative care unit, or contact with a palliative care unit when needed. The objectives with the trial is to investigate if an early establishment with a palliative care unit will have a positive impact on the patients quality of life, this also applies for the nearest relative, survival, and if a difference in numbers of chemotherapy cycles can be detected.
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Project description:Background and study aims
Cancer is one of the main causes of illness, burden and death in Europe. The Joint Research Centre (JRC) of the EU estimated 2.7 million new cancer cases. For all cancers, between 53-79% of men and 41-62% of women are diagnosed with incurable disease. Their cancer treatment is life-prolonging but will not cure the disease.
Cancer is also a major and growing contributor to disability (loss of function). Recent global estimates suggest a loss of 382 disability-adjusted life years per 1000 individuals. Disability is a poorly recognised and undertreated consequence of incurable cancer. Over time, loss of function results in people not being able to continue with valued roles and routines, to manage usual household and social activities, and to self-care. One-third of adults with cancer require assistance to perform basic activities like washing and dressing, and half need help with extended activities like shopping and transportation. Disability reduces quality of life and well-being. Disability related to daily activity is closely related to unplanned hospital admissions and mortality.
Palliative rehabilitation empowers people with incurable conditions to actively manage their condition themselves, enabling them to live fully and enjoy the best health-related quality of life possible, including cancer towards the end of life. It aims to reduce symptoms and help people to stay independent and socially active. WHO policy on Universal Health Coverage states both rehabilitation and palliative care as essential, quality health services. It recommends they be integrated within and between primary, secondary, and tertiary health systems using a multi-professional workforce. While integrated rehabilitation has been achieved for people with chronic respiratory, cardiac and stroke conditions, this is not the case for people with cancer, especially those living with incurable disease. Access to palliative care services has increased but access to rehabilitation remains varied.
In this study, we are evaluating a rehabilitation intervention that has been designed to meet the needs of people living with advanced cancer. The study is taking place in countries across Europe, and we plan to recruit 340 patients from hospitals. We aim to find out if and how the rehabilitation intervention affects the people who take part in the study. We will also study how it fits in with current healthcare services.
Who can participate?
This study is suitable for patients aged 18 or over, diagnosed with advanced solid cancer: lung, colorectal, breast, prostate or other, irrespective of timing in relation to any oncology or palliative care treatments.
What does the study involve?
After signing the informed consent, the participation in this trial will last 16 weeks. Participation in this trial is voluntary and the participants can withdraw any time.
During the first face to face visit, participants will be randomly allocated to receive either INSPIRE rehabilitation intervention + usual care or usual care only. The random allocation will be done using a software maintained by the King’s Clinical Trials Unit.
The trial schedule depends on group allocation:
Participants allocated to usual care only will be asked to complete questionnaires at weeks 4, 8 and 16 either on their own, with a help of a friend or family member, or with the researcher over the telephone or in person. It should take 30 – 45 minutes to compete all the questions.
Participants allocated to the INSPIRE rehabilitation + usual care will be offered up to 3 rehabilitation visits in addition to the questionnaire completion at weeks 4, 8 and 16. Each visit will last 30 -90 minutes.
- 1st rehabilitation visit will be face to face and will be scheduled no later than 14 days after joining the trial. During this visit, a rehabilitation action plan will be put together.
- 2nd rehabilitation will be scheduled around 4 weeks, but no later than 5 weeks after joining the trial.
- 3rd rehabilitation visit will be scheduled around 6 weeks, but no later than 7 weeks after joining the trial.
Both visits 2 and 3 can be face to face, via telephone or via video call and participants will have the opportunity to review and, if needed, change their rehabilitation action plan.
There won’t be any changes in usual care for participants that have been allocated to the rehabilitation intervention group.
Participants allocated to the INSPIRE rehabilitation intervention may also be invited to an optional one-to-one interview with a member of a research team. The interview will last around 30-60 minutes
At the week 28 the research team will look at the participants medical notes to see how they’re getting on; however participants will not need to do anything at this time.
The trial team will collect participants’ medical history and demographic data; however demographic data will be anonymised and only year of birth and initials will be shared with the research teams. All data will be stored on a password-protected database to which only authorised individuals will have access.
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Project description:RATIONALE: Palliative care may help patients with advanced cancer live more comfortably.
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2011-08-09 | E-GEOD-31287 | biostudies-arrayexpress
Project description:The purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients’ and caregivers’ quality of life, mood, coping and understanding of their illness.
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Project description:Leiomyosarcoma (LMS) is a mesenchymal neoplasm with complex copy number alterations and characteristic loss of tumor suppressor genes without known recurrent activating oncogenic mutations. Clinical management of advanced LMS relies on cytotoxic chemotherapy and complementary palliative approaches, and research efforts to date have had limited success identifying clinically actionable biomarkers or targeted therapeutic vulnerabilities. To explore the distinctive biological underpinning of LMS, we evaluated gene expression patterns of LMS cell lines and correlated results with primary tumor samples.
2020-01-22 | GSE143968 | GEO
Project description:Primary outcome(s): To evaluate the effectiveness of early integration of Palliative care in adult patients with HG relapsed/refractory NHL and elderly with newly diagnosed HG NHL by measuring the change in the quality of life using the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) scale and subscales at T1 and T2 when compared to T0.
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Project description:Hepatectomy generally offers the best chance of long-term survival for patients with hepatocellular carcinoma (HCC). Many studies have shown that hepatectomy accelerates tumor metastasis, but the mechanism remains unclear. In this study, palliative hepatectomy was performed in an orthotopic nude mice model of HCC (MHCC97H) with high metastatic potential. Using Human Tumor Metastasis Microarray, we screened the metastasis-related genes in tumor tissues following palliative resection, and found that Metastasis suppressor 1 (MTSS1) located in the central position of gene function net of residual HCC; MTSS1 was up-regulated in residual tumor after palliative resection. Further studies found that MTSS1 enhanced the metastasis of residual HCC. In hepatitis B-related HCC patients undergone palliative hepatectomy, those with higher MTSS1 mRNA expression accompanied by the activation of matrix metalloproteinase 2 (MMP2) in residual HCC, had earlier residual HCC detection after hepatectomy and poorer survival when compared to those with lower MTSS1 level. In different cell lines, the levels of MTSS1 mRNA increased in parallel with metastatic potential. MTSS1 down regulation via siRNA decreased MMP2 activity, reduced invasive potentials of HCC by 28.9% in vitro, and averted the deteriorated lung metastatic extent in vivo. In conclusion, the poor prognosis of hepatitis B-related HCC patients following palliative hepatectomy associates with elevated MTSS1 mRNA expression; therefore, MTSS1 may provide a new research field for HCC diagnosis and treatment. Eighteen nude mice bearing HCC xenografts were randomized into three groups 14 days after orthotopic implantation: palliative resection group (mice received partial HCC resection with preservation of 2 mm tumor pedicles), sham operation group (mice only undergone an exposure of liver but without resection), and blank control group (mice without further surgical intervention). All mice were sacrificed by cervical dislocation 14 days following palliative resection based on pre-experimental results. The first time surgically removed HCC tissues were named tumor tissues T1; the second time surgically removed HCC tissues from sham operation group were named tumor tissues T2; Tissues from blank control group were named tumor tissues T3; Tissues from palliative resection group were named tumor tissues T4 that was residual HCC. Randomly selected 5 tumor specimens from each group were used for the screen of genes related to metastasis by microarray techniques.
2015-12-15 | E-GEOD-75965 | biostudies-arrayexpress
Project description:The aim of this research is to evaluate the quality of life of patients over 75 years of age undergoing palliative chemotherapy for digestive cancer. It is a non-interventional study that evaluates the quality of life before and after a cycle of chemotherapy with a composite criterion including: a standardized questionnaire "Cancer specific quality of Life questionnaire" (QLQC30), an assessment of autonomy by "Activity of daily living" questionnaire (ADL), and the number of days of hospitalization.
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