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Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-Participation Aid
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Metastatic, Quality of life, Decision making

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • H Lee Moffitt Comprehensive Cancer Center
  • Feist-Weiller Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Rapid Estimate of Adult Literacy in Medicine (REALM-SF)
A 7-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy.

Full Information

First Posted
February 19, 2013
Last Updated
July 11, 2017
Sponsor
Northwestern University
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01811264
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 19, 2017 (Actual)
Study Completion Date
May 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Metastatic, Quality of life, Decision making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient-Participation Aid
Other Intervention Name(s)
PPA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy - General (FACT-G)
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.
Time Frame
Change in functional assessment of cancer therapy from pre-visit at 3 months post-visit
Secondary Outcome Measure Information:
Title
Rapid Estimate of Adult Literacy in Medicine (REALM-SF)
Description
A 7-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy.
Time Frame
Pre-Visit
Other Pre-specified Outcome Measures:
Title
Decision Regret Scale
Description
Collected at post-visit, and follow-ups, this measures the patient's regret and feelings regarding the most recent treatment-related decision
Time Frame
Change in decision regret from pre-visit at 3 months post-visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marla Clayman, Ph.D
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
H Lee Moffitt Comprehensive Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Feist-Weiller Cancer Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

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