Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?

NCT01772511 | Completed DMC

• 1 other identifier: 274
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess patients' understanding of clinical trials and to help researchers understand which areas of the informed consent need better explanation for future cancer clinical trial patients.

Conditions

Cancer; Oncology Problem

Keywords

questionnaire; prior therapy; prior study volunteer; prior study patient; cancer; oncology

Outcome Measures

Primary Outcomes (1)

• Understanding of all elements of informed consent via questionnaire

  Comprehension of the important elements of the informed consent forms using questionnaire

  1 month

Secondary Outcomes (1)

• Patient comprehension

  every 6 months, up to 1 year

Study Arms (1)

Questionnaire

Patients will be asked by a member of the research team if they would like to participate in this study evaluating patients' comprehension of the informed consent for the oncology treatment study that they are participating in. Patients will be consented and will be told that, at their next clinical visit, they will be given the questionnaire to complete. They will be given the option to complete the questionnaire on site after being given the document or have the ability to mail the completed questionnaire into the research office once completed. If the questionnaire is not returned within 2-weeks, the participant will be approached again during their normal clinical visit and asked if they still wish to participate in this study.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

All patients entering on this trial will have been enrolled on an oncology clinical trial and are receiving active anti-cancer treatment on that study.

Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer clinic

You may qualify if:

• Patients \> 18 years of age
• Patients are receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy
• Patients must have been consented in English to an oncology treatment clinical study

You may not qualify if:

• Not meeting all eligibility criteria

Sponsors & Collaborators

• Andrew Sch umacher: lead

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

• Schumacher A, Sikov WM, Quesenberry MI, Safran H, Khurshid H, Mitchell KM, Olszewski AJ. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study. PLoS One. 2017 Feb 24;12(2):e0172957. doi: 10.1371/journal.pone.0172957. eCollection 2017.

  PMID: 28235011 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Andrew Schumacher

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 21, 2013
• Study Start: March 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 27, 2015

Record last verified: 2014-12

Locations

US (2)