Lise Nottelmann1,2, Mogens Groenvold3,4, Tove Bahn Vejlgaard2, Morten Aagaard Petersen3, Lars Henrik Jensen5. 1. Institute of Regional Health Research, OPEN, Odense Patient data Explorative Network, Odense University Hospital, University of Southern Denmark, Odense, Denmark. 2. Department of Oncology, Palliative Team, Vejle University Hospital, Vejle, Denmark. 3. The Research Unit, Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, Copenhagen University Hospital, Copenhagen, Denmark. 4. Department of Public Health, University of Copenhagen, Copenhagen, Denmark. 5. Danish Colorectal Cancer Center South, Vejle University Hospital, Denmark and Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark.
Abstract
BACKGROUND: Early integration of palliative care into oncology treatment is widely recommended. Palliative rehabilitation has been suggested as a paradigm which integrates enablement, self-management, and self-care into the holistic model of palliative care. AIM: We hypothesized that early integration of palliative rehabilitation could improve quality of life. DESIGN: The Pal-Rehab study (ClinicalTrials.gov NCT02332317) was a randomized controlled trial. The 12-week intervention offered by a specialized palliative care team was two mandatory consultations and the opportunity of participating in an interdisciplinary group program. Supplementary individual consultations were offered, if needed. SETTING/PARTICIPANTS: At Vejle University Hospital, Denmark, adults diagnosed with advanced cancer within the last 8 weeks were randomized 1:1 to standard oncology care or standard care plus intervention. Assessments at baseline and after six and 12 weeks were based on the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). At baseline participants were asked to choose a "primary problem" from a list of QLQ-C30 domains. The primary endpoint was the change in that "primary problem" measured as area under the curve across 12 weeks (T-scores, European mean value = 50, SD = 10). RESULTS: In all, 288 were randomized of whom 279 were included in the modified intention-to-treat analysis (146 in the standard care group and 133 in the intervention group). The between-group difference for the primary outcome was 3.0 (95% CI [0.0-6.0]; p = 0.047) favoring the intervention. CONCLUSION: Early integration of palliative rehabilitation into standard oncology treatment improved quality of life for newly diagnosed advanced cancer patients. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02332317, registered on December 30, 2014.
RCT Entities:
BACKGROUND: Early integration of palliative care into oncology treatment is widely recommended. Palliative rehabilitation has been suggested as a paradigm which integrates enablement, self-management, and self-care into the holistic model of palliative care. AIM: We hypothesized that early integration of palliative rehabilitation could improve quality of life. DESIGN: The Pal-Rehab study (ClinicalTrials.gov NCT02332317) was a randomized controlled trial. The 12-week intervention offered by a specialized palliative care team was two mandatory consultations and the opportunity of participating in an interdisciplinary group program. Supplementary individual consultations were offered, if needed. SETTING/PARTICIPANTS: At Vejle University Hospital, Denmark, adults diagnosed with advanced cancer within the last 8 weeks were randomized 1:1 to standard oncology care or standard care plus intervention. Assessments at baseline and after six and 12 weeks were based on the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). At baseline participants were asked to choose a "primary problem" from a list of QLQ-C30 domains. The primary endpoint was the change in that "primary problem" measured as area under the curve across 12 weeks (T-scores, European mean value = 50, SD = 10). RESULTS: In all, 288 were randomized of whom 279 were included in the modified intention-to-treat analysis (146 in the standard care group and 133 in the intervention group). The between-group difference for the primary outcome was 3.0 (95% CI [0.0-6.0]; p = 0.047) favoring the intervention. CONCLUSION: Early integration of palliative rehabilitation into standard oncology treatment improved quality of life for newly diagnosed advanced cancerpatients. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02332317, registered on December 30, 2014.
Authors: Jens Lehmann; Maria Rothmund; David Riedl; Gerhard Rumpold; Vincent Grote; Michael J Fischer; Bernhard Holzner Journal: Cancers (Basel) Date: 2021-12-24 Impact factor: 6.639
Authors: Fódhla N Ní Chéileachair; Bridget M Johnston; Cathy Payne; Fiona Cahill; Lisa Mannion; Lisa McGirr; Karen Ryan Journal: HRB Open Res Date: 2022-05-06