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A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol.

ABSTRACT: The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation in a 12-week individually tailored, palliative rehabilitation program initiated shortly after a diagnosis of advanced cancer.This single center, randomized, controlled trial will include 300 patients with newly diagnosed advanced cancer recruited from the Department of Oncology, Vejle Hospital. The patients are randomized to a specialized palliative rehabilitation intervention integrated in standard oncology care or to standard oncology care alone. The intervention consists of a multidisciplinary group program, individual consultations, or a combination of both. At baseline and after six and 12 weeks the patients will be asked to fill out questionnaires on symptoms, quality of life, and symptoms of depression and anxiety. Among the symptoms and problems assessed, patients are asked to indicate the problem they need help with to the largest extent. The effect of the intervention on this problem is the primary outcome measure of the study. Secondary outcome measures include survival and economic consequences.To our knowledge the Pal-Rehab study is the first randomized, controlled, phase III trial to evaluate individually tailored, palliative rehabilitation in standard oncology care initiated shortly after an advanced cancer diagnosis. The study will contribute with evidence on the effectiveness of implementing early palliative care in standard oncology treatment and hopefully offer new knowledge and future directions as to the content of palliative rehabilitation programs.Clinicaltrials.gov Identifier: NCT02332317 , registered retrospectively on December 30, 2014. One study participant had been enrolled at the time.

SUBMITTER: Nottelmann L

PROVIDER: S-EPMC5569500 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol.

Nottelmann Lise L Groenvold Mogens M Vejlgaard Tove Bahn TB Petersen Morten Aagaard MA Jensen Lars Henrik LH

BMC cancer 20170823 1

<h4>Background</h4>The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation in a 12-week individually tailored, palliative rehabilitation program initiated shortly after a diagnosis of advanced cancer.<h4>Methods</h4>This single center, randomized, controlled trial will inc ...[more]

PMID: 28835218

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Project description:ObjectiveTo determine the feasibility of universal genetic testing of women with newly diagnosed breast cancer, to estimate the incidence of pathogenic gene variants and their impact on patient management, and to evaluate patient and clinician acceptance of universal testing.Design, setting, participantsProspective study of women with invasive or high grade in situ breast cancer and unknown germline status discussed at the Parkville Breast Service (Melbourne) multidisciplinary team meeting. Women were recruited to the pilot (12 June 2020 - 22 March 2021) and expansion phases (17 October 2021 - 8 November 2022) of the Mutational Assessment of newly diagnosed breast cancer using Germline and tumour genomICs (MAGIC) study.Main outcome measuresGermline testing by DNA sequencing, filtered for nineteen hereditary breast and ovarian cancer genes that could be classified as actionable; only pathogenic variants were reported. Surveys before and after genetic testing assessed pilot phase participants' perceptions of genetic testing, and psychological distress and cancer-specific worry. A separate survey assessed clinicians' views on universal testing.ResultsPathogenic germline variants were identified in 31 of 474 expanded study phase participants (6.5%), including 28 of 429 women with invasive breast cancer (6.5%). Eighteen of the 31 did not meet current genetic testing eligibility guidelines (probability of a germline pathogenic variant ≥ 10%, based on CanRisk, or Manchester score ≥ 15). Clinical management was changed for 24 of 31 women after identification of a pathogenic variant. Including 68 further women who underwent genetic testing outside the study, 44 of 542 women carried pathogenic variants (8.1%). Acceptance of universal testing was high among both patients (90 of 103, 87%) and clinicians; no decision regret or adverse impact on psychological distress or cancer-specific worry were reported.ConclusionUniversal genetic testing following the diagnosis of breast cancer detects clinically significant germline pathogenic variants that might otherwise be missed because of testing guidelines. Routine testing and reporting of pathogenic variants is feasible and acceptable for both patients and clinicians.

Project description:People with disabilities face challenges accessing basic rehabilitation health care. In 2006, the United Nations Convention on the Rights of Persons with Disabilities (CRPD) outlined the global necessity to meet the rehabilitation needs of people with disabilities, but this goal is often challenged by the undersupply and inequitable distribution of rehabilitation workers. While the aggregate study and monitoring of the physical rehabilitation workforce has been mostly ignored by researchers or policy-makers, this paper aims to present the 'challenges and opportunities' for guiding further long-term research and policies on developing the relatively neglected, highly heterogeneous physical rehabilitation workforce.The challenges were identified through a two-phased investigation. Phase 1: critical review of the rehabilitation workforce literature, organized by the availability, accessibility, acceptability and quality (AAAQ) framework. Phase 2: integrate reviewed data into a SWOT framework to identify the strengths and opportunities to be maximized and the weaknesses and threats to be overcome.The critical review and SWOT analysis have identified the following global situation: (i) needs-based shortages and lack of access to rehabilitation workers, particularly in lower income countries and in rural/remote areas; (ii) deficiencies in the data sources and monitoring structures; and (iii) few exemplary innovations, of both national and international scope, that may help reduce supply-side shortages in underserved areas.Based on the results, we have prioritized the following 'Six Rehab-Workforce Challenges': (1) monitoring supply requirements: accounting for rehabilitation needs and demand; (2) supply data sources: the need for structural improvements; (3) ensuring the study of a whole rehabilitation workforce (i.e. not focused on single professions), including across service levels; (4) staffing underserved locations: the rising of education, attractiveness and tele-service; (5) adapt policy options to different contexts (e.g. rural vs urban), even within a country; and (6) develop international solutions, within an interdependent world.Concrete examples of feasible local, global and research action toward meeting the Six Rehab-Workforce Challenges are provided. Altogether, these may help advance a policy and research agenda for ensuring that an adequate rehabilitation workforce can meet the current and future rehabilitation health needs.

Project description:BackgroundAdvanced heart failure (HF) is characterized by high morbidity and mortality. Conventional therapy may not sufficiently reduce patient suffering and maximize quality of life.ObjectivesThe authors investigated whether an interdisciplinary palliative care intervention in addition to evidence-based HF care improves certain outcomes.MethodsThe authors randomized 150 patients with advanced HF between August 15, 2012, and June 25, 2015, to usual care (UC) (n = 75) or UC plus a palliative care intervention (UC + PAL) (n = 75) at a single center. Primary endpoints were 2 quality-of-life measurements, the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary and the Functional Assessment of Chronic Illness Therapy-Palliative Care scale (FACIT-Pal), assessed at 6 months. Secondary endpoints included assessments of depression and anxiety (measured via the Hospital Anxiety and Depression Scale [HADS]), spiritual well-being (measured via the FACIT-Spiritual Well-Being scale [FACIT-Sp]), hospitalizations, and mortality.ResultsPatients randomized to UC + PAL versus UC alone had clinically significant incremental improvement in KCCQ and FACIT-Pal scores from randomization to 6 months (KCCQ difference = 9.49 points, 95% confidence interval [CI]: 0.94 to 18.05, p = 0.030; FACIT-Pal difference = 11.77 points, 95% CI: 0.84 to 22.71, p = 0.035). Depression improved in UC + PAL patients (HADS-depression difference = -1.94 points; p = 0.020) versus UC-alone patients, with similar findings for anxiety (HADS-anxiety difference = -1.83 points; p = 0.048). Spiritual well-being was improved in UC + PAL versus UC-alone patients (FACIT-Sp difference = 3.98 points; p = 0.027). Randomization to UC + PAL did not affect rehospitalization or mortality.ConclusionsAn interdisciplinary palliative care intervention in advanced HF patients showed consistently greater benefits in quality of life, anxiety, depression, and spiritual well-being compared with UC alone. (Palliative Care in Heart Failure [PAL-HF]; NCT01589601).

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A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol.

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A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol.

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