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Completed

NCT Number: NCT05755347

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

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

Exclusion criteria

  • Exclusion Criteria
  • Inability to read or speak English.
  • 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.
  • Current incarceration.
  • Subject has already received treatment for metastatic breast cancer prior to screening.

Treatment and study plan

General health survey questionnaires

Other

Patient-reported outcome survey will be offered at baseline.

PROMIS Cancer Function Brief 3D profile questionnaires

Other

Patient-reported outcome survey will be offered at baseline.

FACT-G questionnaires

Other

Patient-reported outcome survey will be offered at baseline.

Godin Leisure-Time Exercise Questionnaire

Other

Patient-reported outcome survey will be offered at baseline.

REAP-S questionnaires

Other

Patient-reported outcome survey will be offered at baseline.

Primary outcomes

  1. Physical activity levels

    Time frame: 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 outcomes

  1. Acceptability of survey

    Time frame: Baseline

    Acceptability of survey to subjects will be measured by the percentage of eligible patients who complete the survey.

  2. Health-related quality of life - FACT-G

    Time frame: 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.

  3. Health-related quality of life - PROMIS

    Time frame: 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.

  4. Diet quality

    Time frame: 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.

  5. the percentage of subjects referred

    Time frame: 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.

  6. Barriers to access exercise

    Time frame: Baseline

    Barriers to accessing exercise will be evaluated by questionnaire.

  7. health-related opinions

    Time frame: Baseline

    Health-related opinions regarding prehabilitation interventions will be assessed by questionnaire which includes open-ended questions.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2023
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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