Breast Cancer Clinical Trial

Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

Summary

Through a patient participation aid (PPA) the investigators hope to improve the psychosocial well-being of women diagnosed with metastatic breast cancer by empowering them to be active participants in clinical encounters.

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Full Description

The team has developed a brief Patient Participation Aid (PPA) to promote patient health literacy and encourage women to be active in the decisions that are being made about their healthcare which will lead to their satisfaction with healthcare and improves their psychosocial well-being. The paper-based PPA uses adult learning principles to limit and sequence plain language messages that have been framed from a patient's perspective. The PPA uses theory-based design to increase patients' involvement in the medical visit by modeling - through text and images - how a patient can: 1) set the visit agenda, 2) formulate questions, and 3) assert personal preferences. The specific aims of this study are to: 1- Assess the effectiveness of the PPA to increase patient involvement during clinical encounters. 2- Evaluate the effectiveness of the PPA to improve patient psychosocial outcomes. 3- Explore if the effect of the PPA varies by patients' literacy skills. To achieve this aims, the investigators will conduct a randomized controlled trial to evaluate the PPA among patients with a new diagnosis or progression of metastatic breast cancer at two cancer centers that serve diverse patient populations.

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Eligibility Criteria

Inclusion Criteria:

female patients with metastatic breast cancer seeing one of the study physicians at one of the identified study clinics
age 21 or older
having suspected progression of metastatic disease

Exclusion Criteria:

patients with an uncorrectable hearing impairment or having limited English proficiency, as this would adversely affect their ability to communicate with the physician
patients with uncorrectable vision impairment, as this would make it impractical for the patient to read the intervention
patients too ill to meaningfully converse with the physician

Study is for people with:

Breast Cancer

Estimated Enrollment:

150

Study ID:

NCT01811264

Recruitment Status:

Completed

Sponsor:

Northwestern University

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There are 2 Locations for this study

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H Lee Moffitt Comprehensive Cancer Center
Tampa Florida, 33612, United States
Feist-Weiller Cancer Center
Shreveport Louisiana, 71103, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

150

Study ID:

NCT01811264

Recruitment Status:

Completed

Sponsor:


Northwestern University

How clear is this clinincal trial information?

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