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Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

21 Years
Not Enrolling
Breast Cancer

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Trial Information

Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Marla Clayman, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Institutional Review Board

Study ID:

PPA Study



Start Date:

April 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastatic
  • Quality of life
  • Decision making
  • Breast Neoplasms



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