Palliative care consultants’ ethical concerns with advanced cancer patients participating in phase 1 clinical trials. A case study

Comoretto, Nunziata; Larumbe, Ana; Arantzamendi, María; Centeno, Carlos

doi:10.1080/09699260.2017.1364894

Cited by 3 publications

(3 citation statements)

References 27 publications

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“…This study's primary purpose was to test a PCI for patients with solid tumors undergoing Phase I therapeutic clinical trials in a randomized, two-center study. The study's aims were to compare the intervention versus control groups to: (1) test the effects of a PCI on patients' quality of life (QOL), psychological distress, and satisfaction with oncology care and communication; (2) test the effects of a PCI on patients' symptoms, comparing the intervention versus control groups;…”

Section: Aimsmentioning

confidence: 99%

“…P atients and families participating in Phase I trials can be especially vulnerable and, therefore, may need special attention. [1][2][3][4] Palliative care (PC) has helped in serious illness with better communication, symptom control, knowledge about treatment options and goals, and improved survival. [5][6][7][8][9][10] Phase I patients are generally among the most ''well'' of advanced cancer patients, but even so, in one study they had a symptom burden similar to other oncology patients.…”

Section: Introductionmentioning

confidence: 99%

“…[14][15][16][17] Despite the illness's terminal nature and average survival of just several months, oncologists rarely discuss prognosis during Phase I trial discussions. [1][2][3] A study of Phase I patients verified that nearly half of the patients had some advance care planning, and 59% wanted to discuss this with their health care providers. 18 In addition to a baseline symptom burden, a patient's symptomology while on a Phase I trial may increase during participation.…”

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: Aimsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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Maintaining High-Touch in High-Tech Digital Health Monitoring and Multi-Omics Prognostication: Ethical, Equity, and Societal Considerations in Precision Health for Palliative Care

Viana,

Pilbeam,

Howard

et al. 2023

OMICS: A Journal of Integrative Biology

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Using Patient-Reported Outcomes to Describe the Patient Experience on Phase I Clinical Trials

Sedhom

Ferrell

Ruel

et al. 2020

JNCI Cancer Spectrum

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Background Symptoms are common among patients enrolled in Phase I trials. We assessed the validity of PRO-CTCAE items in relation to previously validated assessments of quality of life and psychological distress. We utilized data from a randomized trial testing a palliative care support intervention for patients enrolled on Phase I trials. Methods Patients (n = 479) were accrued to the parent study prior to initiating a Phase I clinical trial with data collected at baseline, 4, and 12 weeks. We determined the correlation of PRO-CTCAE with Distress Level, FACT-G total and subscale domain scores. Results Patients were predominantly female (56.8%), over age 60, and 30.7% were from minority populations. The correlation coefficient for Distress Level for all PRO-CTCAE items was small to moderate (Pearson r = 0.33 to 0.46). Pearson’s correlation coefficient for FACT-G total was moderate (r = -0.45 to -0.69). Stronger associations were noted for mood items of the PRO-CTCAE only (with Distress Level, r = 0.55 to 0.6; with FACT-G, r = -0.54 to -0.6). PRO-CTCAE symptom interference scores had the strongest correlation with Distress Level (Pearson r = 0.46) and FACT-G Total (Pearson r = -0.69). Correlations between PRO-CTCAE items and corresponding FACT-G (total and subscales) and Distress levels reached statistical significance for all items (p <.001). Conclusion Evidence demonstrates validity of PRO-CTCAE in a heterogeneous US sample of patients undergoing cancer treatment on Phase I trials, with small to moderate correlations with Distress Level for all PRO-CTCAE items, and moderate correlations with quality of life as measured by FACT-G Total.

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Palliative care consultants’ ethical concerns with advanced cancer patients participating in phase 1 clinical trials. A case study

Cited by 3 publications

References 27 publications

A Palliative Care Intervention for Patients on Phase 1 Studies

A Palliative Care Intervention for Patients on Phase 1 Studies

Maintaining High-Touch in High-Tech Digital Health Monitoring and Multi-Omics Prognostication: Ethical, Equity, and Societal Considerations in Precision Health for Palliative Care

Using Patient-Reported Outcomes to Describe the Patient Experience on Phase I Clinical Trials

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