Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastasis | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FACT-G questionnaires | Other | — | UNRESOLVED |
| General health survey questionnaires | Other | — | UNRESOLVED |
| Godin Leisure-Time Exercise Questionnaire | Other | — | UNRESOLVED |
| PROMIS Cancer Function Brief 3D profile questionnaires | Other | — | UNRESOLVED |
| REAP-S questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single Arm
- description
- Subjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires.
- interventionNames
- 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
Primary outcomes (1)
- measure
- Physical activity levels
- timeFrame
- Baseline
- description
- 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 (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available