Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Patient-Participation Aid

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants will begin with a pre-visit structured interview to determine emotional and physical well-being, anxiety, depression, and self-efficacy. Then they will be helped through the Patient-Participation Aid (PPA) by the research assistant (RA). Then they will meet with their doctor while the visit is video-recorded. After they will complete a post-visit interview to see if there were any health decisions made, patients level of involvement, and doctor communication. Follow up phone interviews will be conducted at 1 week and 3 months to assess patients self-reported changes in well-being, anxiety, depression, and decision regret.	Behavioral: Patient-Participation Aid; 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.; Other Names: PPA
No Intervention: Usual Care; Participants will begin with a pre-visit structured interview to determine emotional and physical well-being, anxiety, depression, and self-efficacy. They will have their doctor's visit video recorded. After they will complete a post-visit interview to see if there were any health decisions made, patients level of involvement, and doctor communication.Follow up phone interviews will be conducted at 1 week and 3 months to assess patients self-reported changes in well-being, anxiety, depression, and decision regret.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change in functional assessment of cancer therapy from pre-visit at 3 months post-visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-Visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision Regret Scale	Collected at post-visit, and follow-ups, this measures the patient's regret and feelings regarding the most recent treatment-related decision	Change in decision regret from pre-visit at 3 months post-visit

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Marla Clayman, Ph.D, Northwestern University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): May 19, 2017
• Study Completion (Actual): May 19, 2017

Study Registration Dates

• First Submitted: February 19, 2013
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (Estimate): March 14, 2013

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Quality of life; Metastatic; Decision making
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PPA Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO