Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01811264
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Marla L Clayman, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Patient-Participation Aid Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer
Study Start Date : December 2013
Actual Primary Completion Date : May 19, 2017
Actual Study Completion Date : May 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 Name: 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.



Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy - General (FACT-G) [ Time Frame: Change in functional assessment of cancer therapy from pre-visit at 3 months post-visit ]
    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.


Secondary Outcome Measures :
  1. Rapid Estimate of Adult Literacy in Medicine (REALM-SF) [ Time Frame: Pre-Visit ]
    A 7-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy.


Other Outcome Measures:
  1. Decision Regret Scale [ Time Frame: Change in decision regret from pre-visit at 3 months post-visit ]
    Collected at post-visit, and follow-ups, this measures the patient's regret and feelings regarding the most recent treatment-related decision



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811264


Locations
Layout table for location information
United States, Florida
H Lee Moffitt Comprehensive Cancer Center
Tampa, Florida, United States, 33612
United States, Louisiana
Feist-Weiller Cancer Center
Shreveport, Louisiana, United States, 71103
Sponsors and Collaborators
Northwestern University
American Cancer Society, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Marla Clayman, Ph.D Northwestern University

Layout table for additonal information
Responsible Party: Marla L Clayman, Adjunct Faculty, Northwestern University
ClinicalTrials.gov Identifier: NCT01811264     History of Changes
Other Study ID Numbers: PPA Study
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marla L Clayman, Northwestern University:
Metastatic
Quality of life
Decision making
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases