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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Patient-Participation Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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.
- 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
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
|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|
|Principal Investigator:||Marla Clayman, Ph.D||Northwestern University|