Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation

The Washington University

Status: Completed

Conditions: Cancer

Treatments: Behavioral: Decision Aid (DA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01964222

201309076

Details and patient eligibility

About

This study will update an existing health literacy intervention (decision aid) for informed consent procedures and then conduct a randomized experiment implementing the health literacy intervention at Siteman Cancer Center and evaluate its effectiveness compared to usual care. Our hypothesis is that implementing the targeted, web-based decision aid (DA) in addition to usual care will increase knowledge about cancer clinical trials. Secondary outcomes include patients' ability to communicate with health care providers about trials, willingness to participate in trials, and enrollment rates for minority participants.

Full description

A previously developed and pilot tested web-based decision aid (DA) based on best practices in health literacy that is well received by minority participants and significantly improved knowledge about cancer clinical trials and decision self-efficacy will be used. This study will expand the reach of the DA and test it in a larger study in a different geographic region and center (Siteman Cancer Center). An additional benefit of conducting this work at Siteman Cancer Center is that Siteman and the Program for the Elimination of Cancer Disparities (PECaD) already institute structural changes at the system level to improve minority participation in trials. This study will activate and educate patients and will complement the system-level interventions.

By random 1:1 assignment, 180 participants will either receive:

*Targeted, web-based decision aid (DA) about participating in cancer clinical trials.

or

*Usual care/control-Access to the Siteman Cancer Center website about clinical trials.

Outcomes from the DA group will be compared to outcomes in a usual care/control group.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with cancer in the past 6 months
• English speaking
• At least 18 years old

Exclusion criteria

• Past participation in a clinical trial for treatment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Decision Aid (DA)

Experimental group

Description:

The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.

Treatment:

Behavioral: Decision Aid (DA)

Control

No Intervention group

Description:

Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.