A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials
Abstract Purpose Patients enrolled in Phase 1 clinical trials have typically exhausted standard therapies and often are choosing between a clinical trial and hospice care. Significant symptom burden can result in early trial discontinuation and confound trial outcomes. This study aimed to examine di...
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doaj-9e808bed63da48019eec6c5bd13559532021-07-09T04:54:54ZengWileyCancer Medicine2045-76342021-07-0110134312432110.1002/cam4.3971A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trialsMichelle Treasure0Barbara Daly1Shufen Cao2Pingfu Fu3Augustine Hong4Elizabeth Weinstein5Jessica Surdam6Neal J. Meropol7Afshin Dowlati8Department of Medicine University Hospitals Cleveland Medical CenterSeidman Cancer Center and Case Western Reserve University Cleveland OH USAFrances Payne School of Nursing Case Comprehensive Cancer CenterCase Western Reserve University Cleveland OH USADepartment of Population and Quantitative Health Sciences Case Western Reserve UniversityCase Comprehensive Cancer Center Cleveland OH USADepartment of Population and Quantitative Health Sciences Case Western Reserve UniversityCase Comprehensive Cancer Center Cleveland OH USADepartment of Medicine University Hospitals Cleveland Medical CenterSeidman Cancer Center and Case Western Reserve University Cleveland OH USADepartment of Medicine University Hospitals Cleveland Medical CenterSeidman Cancer Center and Case Western Reserve University Cleveland OH USAUniversity Hospitals Cleveland Medical Center Seidman Cancer CenterCase Comprehensive Cancer CenterCase Western Reserve University Cleveland OH USADepartment of Medicine University Hospitals Cleveland Medical CenterSeidman Cancer Center and Case Western Reserve University Cleveland OH USADepartment of Medicine University Hospitals Cleveland Medical CenterSeidman Cancer Center and Case Western Reserve University Cleveland OH USAAbstract Purpose Patients enrolled in Phase 1 clinical trials have typically exhausted standard therapies and often are choosing between a clinical trial and hospice care. Significant symptom burden can result in early trial discontinuation and confound trial outcomes. This study aimed to examine differences in study duration, symptom burden, adverse events (AE), and quality of life (QOL) between those receiving structured palliative care versus usual supportive care. Patients and methods Sixty‐eight patients enrolled in phase 1 clinical trials and 39 of their CGs were randomly assigned to receive structured palliative care or usual supportive care. Patient QOL was measured monthly using the Functional Assessment of Cancer Therapy and Memorial Symptom Assessment Scale. The Quality of Life in Life‐Threatening Illness–Family Care Version and Caregiver Reaction Assessment were used for CGs. AEs and use of palliative care resources were compared between arms. Results Mean duration of the phase 1 study was 142 days in the palliative care arm versus 116 days in the usual care arm (p = 0.55). Although not statistically significant, patients in the palliative care arm experienced fewer AEs and better QOL, as did their CGs, compared to those receiving usual care. Conclusions Phase 1 patients and their CGs have physical and psychosocial needs warranting palliative care services. Results suggest that structured palliative care is associated with the increased duration of the study and improved patient and CG QOL.https://doi.org/10.1002/cam4.3971 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Michelle Treasure Barbara Daly Shufen Cao Pingfu Fu Augustine Hong Elizabeth Weinstein Jessica Surdam Neal J. Meropol Afshin Dowlati |
spellingShingle |
Michelle Treasure Barbara Daly Shufen Cao Pingfu Fu Augustine Hong Elizabeth Weinstein Jessica Surdam Neal J. Meropol Afshin Dowlati A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials Cancer Medicine |
author_facet |
Michelle Treasure Barbara Daly Shufen Cao Pingfu Fu Augustine Hong Elizabeth Weinstein Jessica Surdam Neal J. Meropol Afshin Dowlati |
author_sort |
Michelle Treasure |
title |
A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials |
title_short |
A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials |
title_full |
A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials |
title_fullStr |
A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials |
title_full_unstemmed |
A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials |
title_sort |
randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials |
publisher |
Wiley |
series |
Cancer Medicine |
issn |
2045-7634 |
publishDate |
2021-07-01 |
description |
Abstract Purpose Patients enrolled in Phase 1 clinical trials have typically exhausted standard therapies and often are choosing between a clinical trial and hospice care. Significant symptom burden can result in early trial discontinuation and confound trial outcomes. This study aimed to examine differences in study duration, symptom burden, adverse events (AE), and quality of life (QOL) between those receiving structured palliative care versus usual supportive care. Patients and methods Sixty‐eight patients enrolled in phase 1 clinical trials and 39 of their CGs were randomly assigned to receive structured palliative care or usual supportive care. Patient QOL was measured monthly using the Functional Assessment of Cancer Therapy and Memorial Symptom Assessment Scale. The Quality of Life in Life‐Threatening Illness–Family Care Version and Caregiver Reaction Assessment were used for CGs. AEs and use of palliative care resources were compared between arms. Results Mean duration of the phase 1 study was 142 days in the palliative care arm versus 116 days in the usual care arm (p = 0.55). Although not statistically significant, patients in the palliative care arm experienced fewer AEs and better QOL, as did their CGs, compared to those receiving usual care. Conclusions Phase 1 patients and their CGs have physical and psychosocial needs warranting palliative care services. Results suggest that structured palliative care is associated with the increased duration of the study and improved patient and CG QOL. |
url |
https://doi.org/10.1002/cam4.3971 |
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