Effects of a CD-ROM educational intervention (CD) on prognosis (prog) understanding among advanced cancer patients (acp) enrolling in early phase clinical trials

e14025 Background: Progression-free survival ratio (PFSr) has been proposed as a direct evaluation of treatment benefit in advanced cancer patients, based on the hypothesis that the natural history of cancer is accelerating and therefore successive lines of treatments become less efficient over time. Consequently, PFS at line +2 (PFS2) is expected to be shorter than PFS at line +1 (PFS1), whereas a PFS2/PFS1 ratio > 1.3 might reflect treatment benefit. However, this hypothesis has been poorly documented, especially in the context of early phase trials where determining treatment benefit is becoming key. We therefore proposed to evaluate PFSr in a large cohort of cancer patients enrolled in early phase clinical trials at Gustave Roussy Drug Development Department. Methods: Patients enrolled in at least two phase 1 studies for advanced solid tumors or lymphomas were retrospectively identified. Demographical, clinical and therapeutic data were collected. Time to progression (PFS) was measured from treatment initiation to progression, using radiological evaluations. Patients who had gone off-trial for reasons other than progression were censored. PFSr was defined as the ratio of the PFS under line 2 divided by the PFS under line 1 and might be censored in presence of censored PFS2. Ratio distribution in this population was estimated using Kaplan Meier. Calibration of the ratio was proposed for hypothesis testing. The influence of therapeutic class and combination versus monotherapy was studied via non parametric Gehan-Wilcoxon tests or Mick tests. Results: 212 patients enrolled between 2009 and 2016 in at least two phase 1 clinical trials were included, corresponding to 113 different clinical trials. PFSr distribution was described and correlated with demographical, clinical and therapeutic data. The relevance of the usual 1.3 PFSr cut-off to determine treatment benefit was evaluated. Final analysis results will be presented at the time of the congress. Conclusions: This study, one of the first to establish PFSr in a large cohort of patients treated in early phase clinical trials, provides guidelines for using PFSr to assess the impact of treatment sequences in advanced cancer patients.

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Attitudes Toward Research Participation and Investigator Conflicts of Interest Among Advanced Cancer Patients Participating in Early Phase Clinical Trials

Journal of Clinical Oncology ◽

10.1200/jco.2007.11.7283 ◽

2007 ◽

Vol 25 (23) ◽

pp. 3488-3494 ◽

Cited By ~ 19

Author(s):

Stacy W. Gray ◽

Fay J. Hlubocky ◽

Mark J. Ratain ◽

Christopher K. Daugherty

Keyword(s):

Clinical Trials ◽

Cancer Patients ◽

Advanced Cancer ◽

Conflict Of Interest ◽

Conflicts Of Interest ◽

Research Participation ◽

Advanced Cancer Patients ◽

Younger Patients ◽

Financial Conflicts Of Interest ◽

Early Phase Clinical Trials

Purpose Although both financial and intrinsic conflicts of interest can exist throughout the drug development process, little is known about how advanced cancer patients enrolled onto early phase clinical trials perceive investigator conflicts of interests. Patients and Methods We interviewed 102 advanced cancer patients enrolled onto phase I clinical trials using a standardized survey that addressed multiple issues related to conflicts of interest and research participation. Results Fifty-five percent of patients would not be concerned if physicians involved in running a clinical trial had financial conflicts of interest, whereas 65% of patients would be concerned if physicians involved in running a trial had intrinsic conflicts of interest. Most patients reported that potential conflicts of interest should be disclosed to patients on research trials (52% for financial conflicts of interest and 61% for more intrinsic conflicts of interest). Most patients would be willing to participate in trials after learning conflict of interest information (63%). Younger patients expressed more concern regarding financial conflict of interest than older patients (odds ratio, 6.22; 95% CI, 1.41 to 27.24). Conclusion Patients with advanced cancer are equally, if not more, concerned about traditional intrinsic conflicts of interest as compared with financial conflicts of interest. Patients generally believed that conflict of interest information should be disclosed to research participants. The fact that younger patients expressed more concern about financial conflicts of interest may have the potential to influence clinical trial participation rates. The actual impact of conflict of interest disclosure to research subjects needs to be evaluated more carefully.

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Time to progression ratio in cancer patients enrolled in early phase clinical trials: time for new guidelines?

British Journal of Cancer ◽

10.1038/s41416-018-0245-0 ◽

2018 ◽

Vol 119 (8) ◽

pp. 937-939 ◽

Cited By ~ 4

Author(s):

Sarah Watson ◽

Jessica Menis ◽

Capucine Baldini ◽

Patricia Martin-Romano ◽

Jean-Marie Michot ◽

...

Keyword(s):

Clinical Trials ◽

Cancer Patients ◽

Early Phase ◽

Time To Progression ◽

New Guidelines ◽

Early Phase Clinical Trials

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Pharmacological management update: clinical significance of anamorelin clinical trials for the treatment of cancer cachexia in advanced cancer patients

Translational Cancer Research ◽

10.21037/tcr.2016.09.10 ◽

2016 ◽

Vol 5 (S3) ◽

pp. S491-S496

Author(s):

Terence Rong De Ng ◽

Eduardo Bruera ◽

Sriram Yennurajalingam

Keyword(s):

Clinical Trials ◽

Cancer Patients ◽

Clinical Significance ◽

Advanced Cancer ◽

Cancer Cachexia ◽

Advanced Cancer Patients ◽

Pharmacological Management

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Individual Meaning-Centered Psychotherapy for Advanced Cancer Patients

10.1093/med/9780199837229.003.0003 ◽

2017 ◽

Author(s):

William Breitbart ◽

Wendy G. Lichtenthal ◽

Allison J. Applebaum ◽

Melissa Masterson

Keyword(s):

Clinical Trials ◽

End Of Life ◽

Cancer Patients ◽

Advanced Cancer ◽

Therapeutic Intervention ◽

Well Being ◽

Existential Psychology ◽

Advanced Cancer Patients ◽

Spiritual Well Being ◽

Existential Concerns

Among the advanced cancer population, existential concerns are major issues that promote significant distress. For patients who are facing death, meaning and the preservation of meaning are not only clinically and existentially important but also central concepts to a therapeutic intervention. Based on Viktor Frankl’s logotherapy and the principles of existential psychology and philosophy, “meaning-centered psychotherapy” was developed to help patients with advanced cancer sustain or enhance a sense of meaning, peace, and purpose in their lives. This chapter provides an overview of work developing and testing individual meaning-centered psychotherapy (IMCP). It provides an overview of the session content in the IMCP intervention. It also presents findings from clinical trials, which support the efficacy of IMCP as an intervention to increase a sense of meaning, spiritual well-being, and hope while decreasing end-of-life despair. Furthermore, it presents difficult scenarios that may arise when delivering IMCP for clinicians interested in this work.

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Realizing better doctor-patient dialogue about choices in palliative care and early phase clinical trial participation: towards an online value clarification tool (OnVaCT)

BMC Palliative Care ◽

10.1186/s12904-019-0486-6 ◽

2019 ◽

Vol 18 (1) ◽

Cited By ~ 2

Author(s):

Liza G. G. van Lent ◽

Nicole K. Stoel ◽

Julia C. M. van Weert ◽

Jelle van Gurp ◽

Maja J. A. de Jonge ◽

...

Keyword(s):

Decision Making ◽

Clinical Trials ◽

Advanced Cancer ◽

Early Phase ◽

Decisional Conflict ◽

Decision Making Process ◽

Medical Oncologists ◽

Post Test ◽

Patient Values ◽

Early Phase Clinical Trials

Abstract Background Patients with advanced cancer for whom standard systemic treatment is no longer available may be offered participation in early phase clinical trials. In the decision making process, both medical-technical information and patient values and preferences are important. Since patients report decisional conflict after deciding on participation in these trials, improving the decision making process is essential. We aim to develop and evaluate an Online Value Clarification Tool (OnVaCT) to assist patients in clarifying their values around this end-of-life decision. This improved sharing of values is hypothesized to support medical oncologists in tailoring their information to individual patients’ needs and, consequently, to support patients in taking decisions in line with their values and reduce decisional conflict. Methods In the first part, patients’ values and preferences and medical oncologists’ views hereupon will be explored in interviews and focus groups to build a first prototype OnVaCT using digital communication (serious gaming). Next, we will test feasibility during think aloud sessions, to deliver a ready-to-implement OnVaCT. In the second part, the OnVaCT, with accompanied training module, will be evaluated in a pre-test (12–18 months before implementation) post-test (12–18 months after implementation) study in three major Dutch cancer centres. We will include 276 patients (> 18 years) with advanced cancer for whom standard systemic therapy is no longer available, and who are referred for participation in early phase clinical trials. The first consultation will be recorded to analyse patient-physician communication regarding the discussion of patients’ values and the decision making process. Three weeks afterwards, decisional conflict will be measured. Discussion This project aims to support the discussion of patient values when considering participation in early phase clinical trials. By including patients before their first appointment with the medical oncologist and recording that consultation, we are able to link decisional conflict to the decision making process, e.g. the communication during consultation. The study faces challenges such as timely including patients within the short period between referral and first consultation. Furthermore, with new treatments being developed rapidly, molecular stratification may affect the patient populations included in the pre-test and post-test periods. Trial registration Netherlands Trial Registry number: NTR7551 (prospective; July 17, 2018).

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Placebo and nocebo effects in randomized double-blind clinical trials for fatigue in advanced cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.9640 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 9640-9640

Author(s):

M. de la Cruz ◽

D. Hui ◽

H. A. Parsons ◽

P. Lynn ◽

C. Parker ◽

...

Keyword(s):

Clinical Trials ◽

Side Effects ◽

Cancer Patients ◽

Advanced Cancer ◽

Randomized Clinical Trials ◽

Placebo Response ◽

Well Being ◽

Advanced Cancer Patients ◽

Edmonton Symptom Assessment Scale ◽

Nocebo Effects

9640 Background: We have previously reported significant placebo response in randomized controlled treatment trials for cancer related fatigue (CRF). We conducted a retrospective study to determine the frequency and predictors of response to placebo and nocebo effect in patients with CRF. Methods: We reviewed patients that received placebo in two previous randomized clinical trials conducted by our group and determined the proportion of patients who demonstrated clinical response to fatigue using an increase (ΔFACIT-F score) > 7 from baseline to day 8, and those with nocebo response as those who reported side effects. Baseline patient characteristics and symptoms recorded from the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects. Results: A total of 105 advanced cancer patients received placebo. 59 (56%) patients responded to placebo (median Δ FACIT-F score of 22). Worse baseline anxiety and well-being subscale score (univariate) and well-being (multivariate, MR) were significantly associated with placebo response. Common side effects reported were insomnia (79%), anorexia (53%), nausea (38%) and restlessness (34%). MR analysis showed that worse baseline (ESAS) sleep, appetite, nausea, and restless are associated with increased reporting of these side effects ( Table ). Conclusions: Nearly half of advanced cancer patients enrolled in the fatigue trials responded to placebo. Worse physical well-being score was associated with placebo response. Patients experiencing specific symptoms at baseline were more likely to report these as side effects of the medication. These findings should be considered in fatigue clinical trial design. [Table: see text] No significant financial relationships to disclose.

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