Clinical trial NCT01811264: Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer
Official title: Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Metastatic
Quality of life
Decision making
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2013-03-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: Change in functional assessment of cancer therapy from pre-visit at 3 months post-visit
Secondary outcomes:
measure: Rapid Estimate of Adult Literacy in Medicine (REALM-SF)
timeFrame: Pre-Visit
Other outcomes:
measure: Decision Regret Scale
timeFrame: Change in decision regret from pre-visit at 3 months post-visit
Locations:
city: Tampa
country: United States
facility: H Lee Moffitt Comprehensive Cancer Center
state: Florida
city: Shreveport
country: United States
facility: Feist-Weiller Cancer Center
state: Louisiana
Study officials:
affiliation: Northwestern University
name: Marla Clayman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: