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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05755347
• Other study ID #: LCCC2241
• Status: Completed
• Start date: March 17, 2023
• Est. completion date: February 5, 2024

Study information

• Verified date: April 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastasis

Intervention

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

Locations

Country	Name	City	State
United States	Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acceptability of survey	Acceptability of survey to subjects will be measured by the percentage of eligible patients who complete the survey.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Barriers to access exercise	Barriers to accessing exercise will be evaluated by questionnaire.	Baseline
Secondary	health-related opinions	Health-related opinions regarding prehabilitation interventions will be assessed by questionnaire which includes open-ended questions.	Baseline

External Links

•   Clinical trials at UNC Lineberger