Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

Northwestern University150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

150

Conditions

Breast Cancer

Interventions

Patient-Participation AidBEHAVIORAL

The PPA consists of a folder that addresses the three behaviors we hope to influence: agenda setting, asking questions, and making preferences known. The information inside contains sample questions for each section, with room for the patient to write her own questions. Each section models behavior by giving context for the items and specific example questions. It also addresses barriers to understanding by indicating that it is acceptable to ask questions when something is not clear or terms are unfamiliar.

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (2)

H Lee Moffitt Comprehensive Cancer Center

Tampa, Florida, United States

Feist-Weiller Cancer Center

Shreveport, Louisiana, United States

Outcomes

Primary Outcomes

Functional Assessment of Cancer Therapy - General (FACT-G)

Evaluated at 30 minutes prior to, one week after, and 3 months after the patients visit with their doctor, this measure collects scales of the social and family well-being, emotional well-being, and functional well-being.

Time frame: Change in functional assessment of cancer therapy from pre-visit at 3 months post-visit

Secondary Outcomes

Rapid Estimate of Adult Literacy in Medicine (REALM-SF)

A 7-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy.

Time frame: Pre-Visit

Data from ClinicalTrials.gov

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