Relationship between phase I study duration and symptom burden

Treasure, Michelle; Daly, Barbara J.; Fu, Pingfu; Kerpedjieva, Svetoslava; Dowlati, Afshin

doi:10.1007/s00520-017-3879-1

Cited by 11 publications

(11 citation statements)

References 17 publications

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“…Symptom burden has been previously reported to increase as patients participate in clinical trials, which was also true in our study. 23 We did not see significant differences between intervention and control groups in symptoms, as measured by the FACT-G physical well-being (PWB) subscale.…”

Section: Dropoutsmentioning

confidence: 66%

“…Finally, patients often have worsening performance status and increasing symptoms as their cancer progresses. [19][20][21][22][23][24] We previously tested a palliative care intervention (PCI) delivered by nurses who recruited and consented patients and caregivers, did baseline PC assessments, worked with an interdisciplinary team (IDT) to create a care plan, and did two teaching sessions with a standardized workbook. 25 In this study, we applied the PCI to a new population of Phase I patients.…”

Section: Introductionmentioning

confidence: 99%

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A Palliative Care Intervention for Patients on Phase 1 Studies

Ferrell

Chung

Hughes

et al. 2021

Journal of Palliative Medicine

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Background: Phase 1 clinical trials remain vital for oncology care. Patients on these trials require supportive care for quality-of-life (QOL) concerns. Objective: To test a Palliative Care Intervention (PCI) for patients with solid tumors enrolled in Phase I therapeutic trials with a priori hypothesis that psychological distress, QOL, satisfaction, symptoms, and resource utilization would be improved in the PCI group. Design: This unblinded randomized trial compared the PCI with usual care in patients accrued to Phase I Clinical Trials. Subjects (n = 479) were followed for 24 weeks, with 12 weeks as the primary outcome. Setting: Two Comprehensive Cancer Centers in the United States. Subjects: A consecutive sample, 21 years or older, English fluency, with solid tumors initiating a Phase 1 trial. Measurements: Psychological Distress (Distress Thermometer), QOL total and subscales (FACT-G), satisfaction (FAM-CARE), survival, and resource utilization (chart audit). Results: PCI subjects showed improved Psychological Distress (-0.47, p = 0.015) and Emotional Well-Being (0.81, p = 0.045), with differences on variables of QOL and distress between sites. High rates of symptommanagement admissions (41.3%) and low rates of Advance Directive completion (39.0%), and hospice enrollment (30.7%), despite a median survival in both groups of 10.1 months from initiating a Phase 1 study. Conclusions: A nurse-delivered PCI can improve some QOL outcomes and distress for patients participating in Phase 1 trials. Greater integration of PC is needed to provide quality care to these patients and to support transitions from treatment to supportive care, especially at the end of life. ClinicalTrials.gov Identifier: NCT01612598.

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Section: Dropoutsmentioning

confidence: 66%

Section: Introductionmentioning

confidence: 99%

A Palliative Care Intervention for Patients on Phase 1 Studies

Ferrell

Chung

Hughes

et al. 2021

Journal of Palliative Medicine

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“…Hui et al [52] found that patients referred for ECMTs have a similar symptom burden to those who were not, despite the perception of higher levels of fitness. A high symptom burden has also been associated with early discontinuation from trials [53], highlighting the potential role for supportive care. Br edart et al [54] suggested that this patient group is more likely to accept increased toxicity to facilitate continued access to trial drugs.…”

Section: The Importance Of Supportive Care In Experimental Cancer Medicinementioning

confidence: 99%

Supportive Care: An Indispensable Component of Modern Oncology

et al. 2020

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The advent of new cancer therapies, alongside expected growth and ageing of the population, better survival rates and associated costs of care, is uncovering a need to more clearly define and integrate supportive care services across the whole spectrum of the disease. The current focus of cancer care is on initial diagnosis and treatment, and end of life care. The Multinational Association of Supportive Care in Cancer defines supportive care as ‘the prevention and management of the adverse effects of cancer and its treatment’. This encompasses the entire cancer journey, and necessitates involvement and integration of most clinical specialties. Optimal supportive care can assist in accurate diagnosis and management, and ultimately improve outcomes. A national strategy to implement supportive care is needed to acknowledge evolving oncology practice, changing disease patterns and the changing patient demographic.

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“…Patients who could continue after two cycles may have had less aggressive deterioration of their disease or experienced clinical benefit. Earlier research showed that the patients who continued could have experienced fewer side-effects of the investigated agents, since they had fewer symptoms of their disease to start with (Anwar et al, 2017;Treasure et al, 2018).…”

Section: Discussionmentioning

confidence: 99%

Self-reported quality of life and hope in phase-I trial participants: An observational prospective cohort study

et al. 2018

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For advanced cancer patients deliberating early clinical trial participation, adequate information about expected effect on quality of life (HRQoL) and hope, may support decision making. The aim was to assess the potential relation of HRQoL to eligibility for phase-I trial participation, and to observe the variations in patient-reported outcomes. Patients completed questionnaires at preconsent (n = 124), baseline (n = 96), and after first evaluation of a phase-I trial (n = 76). The Mann-Whitney U test was used to test differences between eligible and ineligible patients. Univariate logistic regression was performed for eligibility. Factorial repeated-measures ANOVA compared the outcomes of patients continuing vs. stopping participation after first evaluation over time. Eligibility is associated with significant better global health OR = 0.946, 95% CI [0.918, 0.975], p = 0.001, physical functioning OR = 0.959, 95% CI [0.933, 0.985], p = 0.002, role functioning OR = 0.974, 95% CI [0.957, 0.991] and better appetite OR = 1.114 95% CI [1.035, 1.192]. HRQoL outcomes like global health, social functioning and appetite decline in all patients and differ between patients continuing or having to end participation. Over time, hope and tenacity decline in all patients and coping strategies alter in patients stopping participation. Trial participation influences patient-reported outcomes. Global health may predict for eligibility and trial continuation. Informing patients could affect patients' decision making.

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Relationship between phase I study duration and symptom burden

Cited by 11 publications

References 17 publications

A Palliative Care Intervention for Patients on Phase 1 Studies

A Palliative Care Intervention for Patients on Phase 1 Studies

Supportive Care: An Indispensable Component of Modern Oncology

Self-reported quality of life and hope in phase-I trial participants: An observational prospective cohort study

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