Clinical trial participation as part of end-of-life (EOL) cancer care: Associations with medical care near death and bereaved caregivers’ mental health.

9102 Background: Clinical trial participation is necessary to improve existing therapies, encouraged by national guidelines, and common among advanced cancer patients. The relationships between trial participation and important EOL outcomes such as aggressive care are unknown. Methods: Coping with Cancer Study, an NCI-funded multicenter prospective cohort study of advanced cancer patients and their caregivers, enrolled September 2002 – February 2008. Patients were interviewed at baseline, and clinical trial participation was documented by chart review. Patients were followed to death, (median 4.4 months from baseline). Medical care and quality of life (QOL) in the last week of life was assessed by caregiver interview and chart review. Caregiver interview 6 months post-bereavement assessed QOL and mental health (Structured Clinical Interview for the DSM-IV). The primary outcome was aggressive EOL care (ventilation, resuscitation, or chemotherapy in the last week of life). Secondary outcomes were bereaved caregivers’ mental health and QOL. Propensity-score weighting balanced patient characteristics (e.g. clinical variables, EOL preferences) that differed by trial participation. Propensity-score weighted regression models estimated the effect of trial participation on outcomes. Results: Of 246 patients followed to death with non-missing propensity scores, 27 were clinical trial participants. In propensity-score weighted analyses, trial participation was significantly associated with aggressive EOL care [29.6% v 9.1%; adjusted OR (AOR), 12.14; 95% CI, 3.65-40.36], ICU admission, mechanical ventilation, chemotherapy, and a trend toward inferior QOL near death (p = 0.069). Of 180 matched caregivers, trial participation predicted less mental illness [AOR, 0.15; 95% CI 0.04-0.57], major depression [AOR, 0.25; 95% CI, 0.08-0.80], but was unassociated with QOL (p = 0.15) in adjusted analyses. Conclusions: Clinical trial participation is associated with increased risk of aggressive EOL care for advanced cancer patients, but better mental health for bereaved caregivers.

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Improved clinical trial accrual using a communication tool: Best case/worst case—Clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.29_suppl.26 ◽

2015 ◽

Vol 33 (29_suppl) ◽

pp. 26-26 ◽

Cited By ~ 1

Author(s):

Toby Christopher Campbell

Keyword(s):

Lung Cancer ◽

Clinical Trial ◽

Clinical Trials ◽

Cancer Patients ◽

Chart Review ◽

Treatment Options ◽

Advanced Lung Cancer ◽

Trial Participation ◽

Clinical Trial Participation ◽

Worst Case

26 Background: Clinical trials are crucial to the development of new treatments that may improve survival and quality of life for patients. Cancer clinical trials are hampered by chronically low participation rates. A decision support intervention designed to facilitate a shared decision making discussion with cancer patients regarding chemotherapy options could help oncologists align patient preferences with treatment options, including clinical trials. We performed a retrospective chart review comparing lung cancer patients seen in our integrated onco-palliative care clinic (PC) with standard oncology care (SOC) patients for clinical trial participation as a means of assessing potential effectiveness of the tool. The PC clinic is staffed exclusively by the author who also developed the tool. The tool is a combination of a structured discussion paired with a paper diagram the patient takes home which details all the treatment options including best supportive care alone, standard chemotherapy, and a clinical trial. Methods: Charts of every patient seen in our institution with advanced lung cancer from July 2007-June 2011 were reviewed. Eligible patients were those who received any care at our center thus excluding patient seen only for a second opinion. Demographic, treatment details, survival, and hospice utilization data were obtained. There were five oncologists included the SOC group though the vast majority of patients were seen by two providers. All providers (PC and SOC) are academic physicians who work closely together, meet weekly, have clinic on the same day, share the same research staff and have the same promotion requirements. Results: 207 patients with advanced lung cancer were identified, 82 in the PC group. A significantly higher proportion of patients participated in therapeutic clinical trials in the PC group when compared to the SOC group (29% versus 19%, adjusted OR = 2.54, p = 0.014). No difference in overall chemotherapy utilization was seen between the groups. Conclusions: Our chart review provides initial evidence that the best case/worst case: clinical trials tool may help facilitate clinical trial participation in patients with advanced lung cancer who are exploring their options.

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