Skip to main content
An official website of the United States government
Grant Details

Grant Number: 5R01CA152195-05 Interpret this number
Primary Investigator: Dohan, Daniel
Organization: University Of California, San Francisco
Project Title: Before Consent: Cancer Patients' Deliberations About Early Phase Clinical Trials
Fiscal Year: 2014


DESCRIPTION (provided by applicant): This proposal by a new investigator examines decisions made by advanced cancer patients regarding early phase clinical trials. Advances in basic and translational research may herald the arrival of new, targeted therapies that will improve cancer treatment and reduce mortality, but all of these therapies must be tested for safety in early phase (EP) clinical trials before they can benefit the public. Recruiting more patients to EP trials may speed the development of new cancer therapies, and some have argued that trials< participation is a societal obligation. But, those who participate in early phase trials - advanced cancer patients who have run out of standard therapeutic options - are a highly vulnerable population, and current procedures to ensure informed consent are not robust. Even as bioethicists and social and behavioral scientists seek to improve the informed consent process in EP cancer trials, less attention has focused on patients< decision-making in the period before the consent process begins. This study provides a rich descriptive and longitudinal perspective of the "pre-consent" period via three specific aims. For aim 1, focus groups are used to describe providers< role in early phase recruitment. In aim 2, an Advanced Cancer Cohort (ACC, n=150) is assembled using validated quantitative instruments, qualitative interviews, and clinic participant- observation to gather data on ACC patients' EP experiences and decisions as well as the perspectives of family caregivers and providers. Aim 3 analyzes ACC patients< awareness and knowledge of early phase trials (aim 3a), which patients decide to participate in trials and how they make this decision (aim 3b), and the nature and outcome of the informed consent process (aim 3c). Through the development of rich understandings of early phase decision-making before consent, the study findings may have relevance for clinician-investigators and early phase trial programs throughout the United States. The study may identify approaches that can increase EP trial enrollment while also improving patients< ability to provide meaningful informed consent for EP participation.


Decision-making about clinical trial options among older patients with metastatic cancer who have exhausted standard therapies.
Authors: Tsang M. , DeBoer R.J. , Garrett S.B. , Dohan D. .
Source: Journal of geriatric oncology, 2022 Jun; 13(5), p. 594-599.
EPub date: 2022-02-04.
PMID: 35125334
Related Citations

Qualitative Coding in the Computational Era: A Hybrid Approach to Improve Reliability and Reduce Effort for Coding Ethnographic Interviews.
Authors: Li Z. , Dohan D. , Abramson C.M. .
Source: Socius : sociological research for a dynamic world, 2021 Jan-Dec; 7, .
EPub date: 2021-12-06.
PMID: 37091692
Related Citations

Before Consent: Qualitative Analysis of Deliberations of Patients With Advanced Cancer About Early-Phase Clinical Trials.
Authors: Garrett S.B. , Matthews T.M. , Abramson C.M. , Koenig C.J. , Hlubocky F.J. , Daugherty C.K. , Munster P.N. , Dohan D. .
Source: JCO oncology practice, 2020 Jan; 16(1), p. e56-e63.
EPub date: 2019-10-11.
PMID: 31603726
Related Citations

Approaches to decision-making among late-stage melanoma patients: a multifactorial investigation.
Authors: Garrett S.B. , Abramson C.M. , Rendle K.A. , Dohan D. .
Source: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2019 Mar; 27(3), p. 1059-1070.
EPub date: 2018-08-22.
PMID: 30136025
Related Citations

What advanced cancer patients with limited treatment options know about clinical research: a qualitative study.
Authors: Garrett S.B. , Koenig C.J. , Trupin L. , Hlubocky F.J. , Daugherty C.K. , Reinert A. , Munster P. , Dohan D. .
Source: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2017 Oct; 25(10), p. 3235-3242.
EPub date: 2017-05-09.
PMID: 28488050
Related Citations

Interest in initiating an early phase clinical trial: results of a longitudinal study of advanced cancer patients.
Authors: Dunn L.B. , Wiley J. , Garrett S. , Hlubocky F. , Daugherty C. , Trupin L. , Munster P. , Dohan D. .
Source: Psycho-oncology, 2017 Oct; 26(10), p. 1604-1610.
EPub date: 2016-06-20.
PMID: 27233054
Related Citations

The Importance Of Integrating Narrative Into Health Care Decision Making.
Authors: Dohan D. , Garrett S.B. , Rendle K.A. , Halley M. , Abramson C. .
Source: Health affairs (Project Hope), 2016 Apr; 35(4), p. 720-5.
PMID: 27044974
Related Citations

Authors: Abramson C.M. , Dohan D. .
Source: Sociological methodology, 2015-08-01; 45(1), p. 272-319.
EPub date: 2015-04-17.
PMID: 26834296
Related Citations

An exploratory typology of provider responses that encourage and discourage conversation about complementary and integrative medicine during routine oncology visits.
Authors: Koenig C.J. , Ho E.Y. , Trupin L. , Dohan D. .
Source: Patient education and counseling, 2015 Jul; 98(7), p. 857-63.
EPub date: 2015-03-14.
PMID: 25865412
Related Citations

Back to Top