Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:3/30/2017
Start Date:December 2013
End Date:June 2017

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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.

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
We found this trial at
2
sites
Shreveport, Louisiana 71103
Principal Investigator: Terry Davis, Ph.D
Phone: 318-675-8694
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Shreveport, LA
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Tampa, Florida 33612
Principal Investigator: Susan Vadaparampil, Ph.D
Phone: 813-745-1997
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Tampa, FL
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