A Randomized Trial of Recruitment Strategies for Research Participation

Cancer Clinical Trial

Official title:

A Randomized Trial of Recruitment Strategies for Research Participation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697799
• Other study ID #: 823491
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: October 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a multicenter, randomized clinical trial of attitudes towards research participation, we will evaluate the ethics, effectiveness, and cost- effectiveness of three recruitment strategies for research participation in a mobility trial among hospitalized patients and a smoking cessation trial among patients with depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1296
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Eligible for parent RCT

2. 18 years or older

3. No prior knowledge of recruitment strategies used for this trial

4. Speaks English

Exclusion Criteria:

1)Prior knowledge of recruitment strategies used for this trial

Related Conditions & MeSH terms

• Cancer
• Research Ethics
• This Study Will Focus on Recruitment Strategies and Attitudes Towards Research Among Patients Considering Participation in 2 Parent Randomized Controlled Trials

Intervention

Behavioral:
• High-level recruitment strategy consent form
Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a high-level recruitment strategy
• Mid-level recruitment strategy consent form
Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a mid-level recruitment strategy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University - Feinberg School of Medicine	Chicago	Illinois
United States	The University of Texas, MD Anderson Cancer Center	Houston	Texas
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University Siteman Cancer Center	Saint Louis	Missouri

Sponsors (5)

Lead Sponsor	Collaborator
University of Pennsylvania	M.D. Anderson Cancer Center, Massachusetts General Hospital, Northwestern University, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the proportion of people assigned to each recruitment strategy that consent to participate in the three parent RCTs.		Immediate- Several Days
Secondary	Attitudes towards research	Attitudes towards research will be measured using the Research Attitudes Questionnaire-7 (RAQ-7). Originally designed with 11 items, a shorter 7-item version (RAQ-7) has been shown to have improved internal consistency and factorial validity.	Immediate
Secondary	Attention to informed consent	We will assess the amount of time patients spend reading each part of the parent RCT consent forms. On-site research coordinators will facilitate the collection of this data as patients read the document via the recruitment strategy study's electronic database.	Immediate
Secondary	Perceived risks of the research	Perceived risks of the research will be measured by the 9-item compared riskiness scale, which assesses perceptions of research risk. Using this approach, patients compare their assessment of the riskiness of the RCTs to other salient and more commonly encountered risks. Such comparative assessments have been shown to be less susceptible to errors in scale calibration than isolated ratings of risks.	Immediate
Secondary	Incidence of therapeutic misconceptions	We will assess patients' ability to distinguish research from individualized patient care by measuring rates of therapeutic misconception across recruitment strategies among patients considering participation in the parent RCTs. We will assess this outcome with a 4-item tool developed by Dr. Scott Kim, which has been used for similar purposes in several research contexts.	Immediate
Secondary	Understanding of the trial	To assess whether increased attention translates into improved understanding of the parent RCTs, we will use a 6-item Trial Elements Quiz, featuring core elements of the parent RCTs' consent form.	Immediate
Secondary	Perceptions of influence or coercion	To measure general perception of coercion and voluntariness of research participation, we will use the five-item Perceived Coercion Scale of the MacArthur Admission Experience Survey. The true/false scale is tailored to measure patients' perceptions of coercion in the inpatient psychiatric treatment admission process; we have edited the wording to make it relevant to participation in the parent RCTs.	Immediate
Secondary	Retention through the end of treatment sessions	We will assess the impact of the recruitment strategies on retention status in the protocol of the parent RCTs.	8 - 27 weeks