C09-B “This is kind of like the last hope” : Caregivers' Experience in Decision-Making When Palliative Cancer Patients Are Enrolled in Phase 1 Clinical Trials

Purpose Few interventions have been designed and tested to improve recruitment to clinical trials in oncology. The multiple factors influencing patients' decisions have made the prioritization of specific interventions challenging. The present study was undertaken to identify the independent predictors of a cancer patient's decision to enter a randomized clinical trial. Methods A list of factors from the medical literature was augmented with a series of focus groups involving cancer patients, physicians, and clinical research associates (CRAs). A series of questionnaires was developed with items based on these factors and were administered concurrently to 189 cancer patients, their physicians, and CRAs following the patient's decision regarding trial entry. Forward logistic regression modeling was performed using the items significantly correlated (by univariate analysis) with the decision to enter a clinical trial. Results A number of items were significantly correlated with the patient's decision. In the multivariate logistic regression model, the patient's perception of personal benefit was the most important, with an odds ratio (OR) of 3.08 (P < .05). CRA-related items involving supportive aspects of the decision-making process were also important. These included whether the CRA helped with the decision (OR = 1.71; P < .05), and whether the decision was hard for the patient to make (OR = 0.52; P < .05). Conclusion Strategies that better address the potential benefits of trial entry may result in improved accrual. Interventions or aids that focus on the supportive aspects of the decision-making process while respecting the need for information and patient autonomy may also lead to meaningful improvements in accrual.

Download Full-text

Development, and Evaluation of a Decision Aid to Support Patients’ Participa-tory Decision-making on Tumor-specific and Palliative Therapy in Advanced Cancer Patients: A Study Protocol. (Preprint)

10.2196/preprints.24954 ◽

2020 ◽

Author(s):

Katsiaryna Laryionava ◽

Jan Schildmann ◽

Michael Wensing ◽

Ullrich Wedding ◽

Bastian Surmann ◽

...

Keyword(s):

Health Care ◽

Decision Making ◽

Clinical Trials ◽

Cancer Patients ◽

Advanced Cancer ◽

Health Care Providers ◽

Study Protocol ◽

Care Providers ◽

Advanced Cancer Patients ◽

Design Study

BACKGROUND To support advanced cancer patients, for whom standard therapy is no longer avail-able, and their oncologists in therapy decisions, we aim to develop a decision-making aid (DA) in a multi-phased bicentric study. The DA aims to help patients to better un-derstand risks and benefits of available treatment options including the options of standard palliative care, off-label drug use within an individual treatment plan and involvement in clinical trials. OBJECTIVE This study protocol outlines the development and testing of a DA in a pre-post design study targeting at a heterogeneous population of advanced cancer patients. METHODS In phase I, The DA will be developed after of decisional needs of patients and views of health care providers based on face-to face interviews and focus groups discus-sions. Subsequently, the DA will be alpha-tested and redrafted, as necessary, in phase II. In phase III, the DA will be (1) beta-tested with patients and oncologists and (2) assessed by experts. In the last project phase, we will run a pre-post design study with n= 70 doctor-patient-encounters to access improvements on primary study outcome, i.e. patients’ level of decisional conflict. In addition, the user ac-ceptance will be tested. RESULTS Interviews with cancer patients, oncologists and health care providers have been completed. CONCLUSIONS A unique feature of this study is the development of a DA for patients with different types of advanced cancer, which covers a wide range of topics relevant for patients near the end of life such as forgoing cancer-specific therapy and patients’ inclusion in clinical trials. CLINICALTRIAL NCT04606238 https://clinicaltrials.gov/ct2/show/NCT04606238

Download Full-text

Perception and knowledge of clinical trials and factors affecting participation of regional and rural cancer patients of North Queensland

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e17558 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e17558-e17558

Author(s):

S. S. Sabesan ◽

B. Burgher ◽

S. Varma ◽

P. Piliouras

Keyword(s):

Clinical Trials ◽

Phase I ◽

Cancer Patients ◽

Phase 1 ◽

Willingness To Participate ◽

Or Education ◽

Factors Affecting ◽

Significant Relationships ◽

Rural Patients ◽

Phase I And Ii

e17558 Background: The best treatment option for most cancers is participation in clinical trials. Participation in trials is generally low and among rural patients it is likely to be even lower. The aim of this study was to assess knowledge about and attitudes towards clinical trials among rural and regional cancer patients of North Queensland. Methods: A questionnaire-based survey was conducted in outpatient clinics at the Townsville Cancer Centre on all types of cancer patients. Results: The mean age of the 178 participants was 56 years and 45.4% lived in rural or remote areas. Median distance to the trial centre (Townsville) for rural participants was 180 km (range 80 - 1300 km). Being asked whether they would take part in a RCT, 13.2% of participants said no, 56.3% said yes, and 30.5% were unsure. There were no significant relationships between willingness to participate and rurality (p = 0.896) or education level (p = 0.943). For the majority of patients, the number of clinic visits and blood tests required did not matter. Cost of travel (41.1% rural/remote; 23.5% regional; p < 0.001) and the need for family or friends to accompany (38.9% rural/remote; 24.1% regional; p = 0.021) were more important for rural/remote than regional patients as factors affecting participation. Only 16.4% of participants were aware of early studies. After education, percentage of patients willing to participate in phase I and II studies were 57% and 84%, respectively. Rural patients were less willing to participate in phase I studies than regional patients (33.9% vs 52.6%, p = 0.029). Conclusions: Rural patients are as interested in participating in clinical trials as urban patients except for phase 1 trials and should not be excluded because of rurality. Knowledge of trials is poor and there is a need for education early. Cost of travel seems more important for rural patients and as such budgets should include cost of travel to encourage participation of rural patients. No significant financial relationships to disclose.

Download Full-text

Perceptions concerning clinical trials in oncology patients.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e16533 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e16533-e16533

Author(s):

Dana Lee ◽

Ju-Hsien Chao ◽

Sandy Stevens ◽

Goetz H. Kloecker

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Cancer Patients ◽

Treatment Option ◽

Phase 1 ◽

Cancer Center ◽

Line Treatment ◽

Newly Diagnosed ◽

First Line ◽

Oncology Patients

e16533 Background: Accrual to clinical trials among adult cancer patients is persistently low. Patient preference plays an important role in enrollment. To identify the reasons why patients decline study participation, it is important, to evaluate the perceptions of newly diagnosed oncology patients about clinical trials. Methods: Patients were given a ten-question survey reflective of their attitudes regarding clinical trials as a treatment option at their initial visit. The self-directed questionnaire was scored on an ordinate scale from strongly agree (1) to strongly disagree (5). Results: Ninety-two new patients were surveyed in the cancer - specific multispecialty clinics in an academic cancer center. The patients expected information relating to eligible clinical trials and privacy protection by university sponsored studies as they strongly concurred with “I expect my doctor to inform me about clinical trials that I am eligible for” (mean score 2.15, p=0.001) followed by “all possible measures to protect my privacy are likely to be taken in a clinical trial that is sponsored by a university” (2.36, p=0.36). The strongest disagreement was “If enrolled in a clinical trial, I am comfortable being assigned by a method such as ‘flipping a coin’ or ‘throwing a dice’” (3.73, p=0.001) and “I would be willing to participate in a clinical trial as a first line treatment option” (3.50, p=0.001). Industry sponsored trials, phase 1 trials, second line treatment trials, privacy concerns and investigator initiated trials and time commitment and altruistic reasons did not significantly deviate from the mean preference (2.5) by a one sample T-test analysis. Conclusions: Patients consider the option of clinical trials as important in their treatment, and expect to be informed by their oncologist about clinical trials. Newly diagnosed cancer patients perceive randomization and first line trials negatively. Since randomized data provides new standards for care and hope for improved treatment, patients and their families must be educated about their importance.

Download Full-text

Left Versus Right: Does Location Matter for Refractory Metastatic Colorectal Cancer Patients in Phase 1 Clinical Trials?

Journal of Gastrointestinal Cancer ◽

10.1007/s12029-017-9948-3 ◽

2017 ◽

Vol 49 (3) ◽

pp. 283-287 ◽

Cited By ~ 2

Author(s):

Sukeshi Patel Arora ◽

Norma S. Ketchum ◽

Joel Michalek ◽

Jonathon Gelfond ◽

Devalingam Mahalingam

Keyword(s):

Colorectal Cancer ◽

Clinical Trials ◽

Metastatic Colorectal Cancer ◽

Cancer Patients ◽

Phase 1 ◽

Colorectal Cancer Patients

Download Full-text

Continuous intravenous vitamin C in the cancer treatment: re-evaluation of a Phase I clinical study

Functional Foods in Health and Disease ◽

10.31989/ffhd.v9i3.590 ◽

2019 ◽

Vol 9 (3) ◽

pp. 180

Author(s):

Nina Mikirova ◽

Joseph Casciari ◽

Ronald Hunninghake

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Vitamin C ◽

Phase I ◽

Cancer Patients ◽

Phase 1 ◽

Cancer Prognosis ◽

Sodium Ascorbate ◽

High Dose ◽

Treatment Schedule

Background: Intravenous high-dose vitamin C (IVC) therapy is widely used in naturopathic and integrative oncology. A number of Phase I and Phase II clinical trials were launched to prove the benefits of the IVC therapy. Many case studies demonstrated the effectiveness of IVC, with various degrees of success. Clinical trials using IVC to treat cancer have, to date, demonstrated its safety without conclusively proven its efficacy. One difficulty in administering IVC is determining the optimal treatment schedule. To this end, data from a previous Phase 1 clinical trial conducted in 1998 using continuous vitamin C infusions was analyzed to examine the effects of this regimen on key prognostic parameters. Method: Twenty-four subjects were given continuous IVC at doses between 150 and 710 mg/kg/day. Most of the patients had colon cancer with liver and lung metastasis and three patients had pancreatic or liver cancer. All patients had several chemotherapy/radiation treatments before entering the study. Patients were treated by pharmaceutical grade sodium ascorbate diluted in Lactated Ringers solution with the rate of infusion of 20 ml/hr or 10 ml/hr for lower doses. This diluted solution was administered by continuous infusion.Results: Prior to treatment, serum lymphocyte counts and ascorbate concentrations tended to be low while serum levels of lactate dehydrogenase (LDH), neutrophils, and glucose tended to be high. Improvements were seen during IVC therapy. In patients with initially elevated neutrophil levels, numbers tended to decrease. In contrast, increased absolute neutrophil and lymphocyte numbers were seen in patients with initially low counts. Neutrophil to lymphocyte ratios (NLR) proved to be a good indicator of cancer patients’ survival times (high NLR, low survival). This was also true of LDH, creatinine, and glucose concentrations. In patients with the highest pre-treatment NLR, rate of growth of this ratio decreased significantly during therapy. IVC treatments were also associated with decreases in glucose concentrations, restoration of vitamin C levels, and, in about 40% of cases, reductions in LDH levels. Conclusions: As the result of the study we found that continuous IVC infusions improved several parameters associated with poor cancer prognosis. The data suggests a strategic benefit to using lower IVC doses in continuous infusions: raising the dose above 300 mg/kg/day (20 grams in 70 kg human) increased the frequency of side effects without noticeably increasing plasma ascorbate levels. Moreover, improvements in lymphocyte counts at low IVC doses tended to decrease at the higher doses. In conclusion, continuous infusions had benefits to cancer patients and further research in this area is warranted.Keywords: ascorbic acid; continuous infusion; cancer patients; clinical trial; lymphopenia; neutrophil to lymphocyte ratio; hyperglycemia; safety.

Download Full-text

Ovarian cancer clinical trials: Study the studies to terminate the terminations.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.6069 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 6069-6069

Author(s):

Daniel Spinosa ◽

Elizabeth Howell ◽

D'Erryl Williams ◽

Catherine Watson ◽

Tomi F. Akinyemiju ◽

...

Keyword(s):

Ovarian Cancer ◽

Clinical Trials ◽

Cancer Patients ◽

Phase 1 ◽

Early Termination ◽

Single Type ◽

Cancer Clinical Trials ◽

Academic Center ◽

Early Phase Trials ◽

Missed Opportunity

6069 Background: Clinical trials safely expand the arsenal of treatments available to future patients while providing hope to current patients, particularly ovarian cancer patients who often have poor prognoses. Trial termination for lack of efficacy or unacceptable toxicity are consistent with the aim of protecting patients in the pursuit of knowledge, but those are not the only reasons trials terminate early. Understanding why some clinical trials do not achieve their stated goals may aid in the design of future trials. Methods: Data were gathered from clinical trials registered to ClinicalTrials.gov. Included trials were interventional (as opposed to observational), were closed between 2004 and 2019, enrolled ovarian cancer patients, had submitted results, and were open at one or more domestic sites. For each trial, data were captured regarding study completion, reason for non-completion (if applicable), sites, phase, sponsor (defined as the study initiator, not necessarily the funder), and intervention type. Results: A total of 313 trials were examined, of which 262 met inclusion criteria. Of the 262 evaluable trials, 189 (72%) were completed and 72 (27%) terminated early. The most common reasons for early termination were low accrual (27 trials, 38%), lack of efficacy (15 trials, 21%), or insufficient funding (9 trials, 13%). Five trials (7%) were terminated early due to toxicity. Early phase trials are less likely to complete enrollment, with 11 out of 16 (65%) phase 1 trials, 135 out of 180 (75%) phase 2 trials, and 15 out of 16 (94%) phase 3 trials completed. Trials initiated by an academic center were twice as likely to be terminated early (41/103, 40%) as those initiated by industry (16/80, 20%), with remaining trials initiated by consortia, NCI, or non-academic oncology practices. Terminated trials were open at an average of 11 sites (range 1-317), while completed trials were open at an average of 27 sites (range 1-632). Trials that had multiple types of interventions, for instance a drug and a procedure, had a 34% early termination rate which was higher than the rate for trials with any single type of intervention. Conclusions: More than one in four ovarian cancer clinical trials are terminated early, rarely due to treatment efficacy or tolerability. Trials terminated for reasons other than patient outcomes represent a misallocation of resources or a missed opportunity for innovation. Further research is needed to understand the circumstances that allow for clinical trial completion such that available resources maximize patient benefit.

Download Full-text