Assessing Functional Status Needs Via PRO Measures for Pts With Metastatic Breast Cancer

Assessing Functional Status Needs Via Patient-Reported Outcomes Measures in the Pre-treatment Setting With Metastatic Breast Cancer Patients

The purpose of this single-site non-randomized study is to identify areas of need related to functional status and overall health, including nutrition and mental health in subjects with metastatic breast cancer (MBC). A decline in functional status is observed after breast cancer diagnosis and exacerbated by treatment. Declining functional status impacts the quality of life and can lead to increased comorbidity burden, hospitalization, and increased mortality. Functional status is assessed by specific provider-graded scales. Patient Reported Outcome (PRO) measures may better assess certain aspects of patient health and symptom domains. Thus, potentially supporting the future implementation of effective prehabilitation strategies. This study explores whether a PRO-based survey will identify the physical and emotional health and the social and financial status of patients newly diagnosed with MBC.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Metastasis
• Intervention / Treatment: Other: General health survey questionnaires; Other: PROMIS Cancer Function Brief 3D profile questionnaires; Other: FACT-G questionnaires; Other: Godin Leisure-Time Exercise Questionnaire; Other: REAP-S questionnaires

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

• Study Contact: Name: Stephen Rego; Phone Number: (919) 445-4255; Email: srego@ad.unc.edu
• Study Contact Backup: Name: Carly Bailey; Email: carly_bailey@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subject with metastatic breast cancer receive treatment at the University of North Carolina, Lineberger Comprehensive Cancer Center.

Description

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

1. Written informed consent was obtained from participants in the study and HIPAA authorization for release of personal health information.
2. Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
3. Age ≥ 18 years at the time of consent.
4. Recent diagnosis of new metastatic breast cancer at time of screening.

Exclusion Criteria:

1. Exclusion Criteria
2. Inability to read or speak English.
3. Dementia, altered mental status, or any psychiatric condition as determined by clinical or study team that would prohibit the understanding or rendering of informed consent.
4. Current incarceration.
5. Subject has already received treatment for metastatic breast cancer prior to screening.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single Arm; Subjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires.

Other: General health survey questionnaires; Patient-reported outcome survey will be offered at baseline.; Other: PROMIS Cancer Function Brief 3D profile questionnaires; Patient-reported outcome survey will be offered at baseline.; Other: FACT-G questionnaires; Patient-reported outcome survey will be offered at baseline.; Other: Godin Leisure-Time Exercise Questionnaire; Patient-reported outcome survey will be offered at baseline.; Other: REAP-S questionnaires; Patient-reported outcome survey will be offered at baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity levels	Physical activity levels will be measured using the Godin Leisure-Time Exercise Questionnaire. Godin Leisure-Time Exercise Questionnaire has 3 dichotomous questions, answers will be "yes" or "no". There will be reason questions if the answer is no.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of survey	Acceptability of survey to subjects will be measured by the percentage of eligible patients who complete the survey.	Baseline
Health-related quality of life - FACT-G	Health-related quality of life will be measured by Functional Assessment of Cancer Therapy (FACT-G) which is a survey assessing physical, emotional, and functional well-being on a Likert-type scale. higher scores demonstrating higher health-related quality of life, from 0 to 4. Higher scores represent better QOL.	Baseline
Health-related quality of life - PROMIS	The patient-Reported Outcomes Measurement Information System (PROMIS) survey will assess physical function, fatigue, and social participation. This survey was designed for cancer rehabilitation needs. It asks patients on a Likert-type scale about their ability to perform mobility and activities of daily living tasks along with the frequency of fatigue and ability to participate in vocational and avocational activities.	Baseline
Diet quality	The diet quality will be measured using a modified version of the Rapid Eating Assessment for Participants (REAP-S) survey will assess diet and nutrition quality. For the general population, a score of 32 or higher determines a high-quality/desirable diet. The survey asks about the intake of nutrients including vegetables/fruit, whole grains, types of fat, calcium-rich foods, and others. Responses usually/often receive 1 point, sometimes receive 2 points, and rarely/do not apply to receive 3 points.	Baseline
the percentage of subjects referred	the percentage of subjects referred will be defined as subjects who have been referred to or used Lineberger Comprehensive Cancer Center supportive services for patients Referral rates will be reported for an array of the University of North Carolina Lineberger supportive services by questionnaire.	Baseline
Barriers to access exercise	Barriers to accessing exercise will be evaluated by questionnaire.	Baseline
health-related opinions	Health-related opinions regarding prehabilitation interventions will be assessed by questionnaire which includes open-ended questions.	Baseline

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Sasha Knowlton, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• Clinical trials at UNC Lineberger

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Actual): February 5, 2024
• Study Completion (Actual): February 5, 2024

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; functional status; patient reported outcomes
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LCCC2241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No