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

Completed

• Conditions: Breast Cancer; Metastasis
• Interventions: 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

• Registration Number: NCT05755347
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-06
• Study Start: 2023-03-17
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Arm	PROMIS Cancer Function Brief 3D profile questionnaires	Subjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires.
Single Arm	General health survey questionnaires	Subjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires.
Single Arm	FACT-G questionnaires	Subjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires.
Single Arm	REAP-S questionnaires	Subjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires.
Single Arm	Godin Leisure-Time Exercise Questionnaire	Subjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires.

Primary Outcome Measures

Name	Time	Method
Physical activity levels	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Diet quality	Baseline	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.
Health-related quality of life - FACT-G	Baseline	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.
health-related opinions	Baseline	Health-related opinions regarding prehabilitation interventions will be assessed by questionnaire which includes open-ended questions.
the percentage of subjects referred	Baseline	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.
Barriers to access exercise	Baseline	Barriers to accessing exercise will be evaluated by questionnaire.
Acceptability of survey	Baseline	Acceptability of survey to subjects will be measured by the percentage of eligible patients who complete the survey.
Health-related quality of life - PROMIS	Baseline	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.

Trial Locations

Locations (1)

Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States