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Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05064098
Recruitment Status : Recruiting
First Posted : October 1, 2021
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life.

Condition or disease
Breast Cancer

Detailed Description:
This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life. It will also provide the research team with improved understanding of how patients interact with and prefer to receive QOL information. Improved understanding of patient predictions and perceptions of information display will allow us to incorporate predicted future PROs into the shared decision making process as well as allow us to provide this important information to patients in a meaningful way.
Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients
Actual Study Start Date : June 29, 2021
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort
Pre-Surgical Breast Cancer Patients
Adult female patients newly diagnosed with stage 0-III breast cancer seen as a surgical consultation from 06/01/2019 to present.
Breast Cancer Survivors
Breast Cancer Survivors


Outcome Measures
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Primary Outcome Measures :
  1. Predicted patient reported outcomes up to 1 year after [ Time Frame: 12 months ]
    Predicted patient reported outcomes for each domain six-months and 1 year after breast surgery.

  2. Actual patient reported outcomes for each domain after surgery [ Time Frame: 6 month ]
    Actual PRO scores for each domain six-months after surgery

  3. Compare predicted and actual outcomes [ Time Frame: 12 months ]
    Comparison of predicted versus actual PRO scores in patients undergoing surgery

  4. Patients preferred method of communicating results [ Time Frame: 12 months ]
    Patients' preferred means of receiving and communicating PRO results.


Eligibility Criteria
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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.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pre-surgical breast cancer patients and breast cancer survivors
Criteria

Inclusion Criteria:

  • Pre-surgical female breast cancer patients
  • Female breast cancer survivors

Exclusion Criteria:

-

Contacts and Locations
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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): NCT05064098


Contacts
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Contact: Victoria Huynh 8327202162 victoria.d.huynh@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Hopspital Recruiting
Aurora, Colorado, United States, 80045
Contact: Victoria Huynh    832-720-2162    victoria.d.huynh@cuanschutz.edu   
Principal Investigator: Sarah Tevis, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Sarah Tevis University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05064098    
Other Study ID Numbers: 21-3576.cc
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases