Breast CancerNCT05755347
Assessing Functional Status Needs Via PRO Measures for Pts With Metastatic Breast Cancer
An observational study of Breast Cancer and Metastasis, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastasis
- What is being tested?
- General health survey questionnaires, PROMIS Cancer Function Brief 3D profile questionnaires and FACT-G questionnaires
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2023to 5 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subject with metastatic breast cancer receive treatment at the University of North Carolina, Lineberger Comprehensive Cancer Center.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
- Conditions
- Breast Cancer, Metastasis
- Being tested
- General health survey questionnaires, PROMIS Cancer Function Brief 3D profile questionnaires, FACT-G questionnaires, Godin Leisure-Time Exercise Questionnaire, REAP-S questionnaires
- Keywords
- patient reported outcomes, quality of life, functional status
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General health survey questionnairesOther
Patient-reported outcome survey will be offered at baseline.
PROMIS Cancer Function Brief 3D profile questionnairesOther
Patient-reported outcome survey will be offered at baseline.
FACT-G questionnairesOther
Patient-reported outcome survey will be offered at baseline.
Godin Leisure-Time Exercise QuestionnaireOther
Patient-reported outcome survey will be offered at baseline.
REAP-S questionnairesOther
Patient-reported outcome survey will be offered at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Subjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (7)
Acceptability of survey
Acceptability of survey to subjects will be measured by the percentage of eligible patients who complete the survey.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Barriers to access exercise
Barriers to accessing exercise will be evaluated by questionnaire.
Measured: Baseline
health-related opinions
Health-related opinions regarding prehabilitation interventions will be assessed by questionnaire which includes open-ended questions.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start17 Mar 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sasha Knowlton, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755347
- Sponsor's protocol ID
- LCCC2241
- Status last verified
- Apr 2024
- First submitted
- 22 Feb 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Functional Status Needs Via Patient-Reported Outcomes Measures in the Pre-treatment Setting With Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05755347
- Acronym / sponsor ID
- LCCC2241
- Conditions
- Breast Cancer, Metastasis
- Keywords
- patient reported outcomes, quality of life, functional status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | 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 questionnairesSubjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subject with metastatic breast cancer receive treatment at the University of North Carolina, Lineberger Comprehensive Cancer Center.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General health survey questionnairesPatient-reported outcome survey will be offered at baseline. | Other | Single Arm |
| PROMIS Cancer Function Brief 3D profile questionnairesPatient-reported outcome survey will be offered at baseline. | Other | Single Arm |
| FACT-G questionnairesPatient-reported outcome survey will be offered at baseline. | Other | Single Arm |
| Godin Leisure-Time Exercise QuestionnairePatient-reported outcome survey will be offered at baseline. | Other | Single Arm |
| REAP-S questionnairesPatient-reported outcome survey will be offered at baseline. | Other | Single Arm |
Primary outcome
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.
7 secondary outcomes
Acceptability of survey
Time frame: Baseline
Health-related quality of life - FACT-G
Time frame: Baseline
Health-related quality of life - PROMIS
Time frame: Baseline
Diet quality
Time frame: Baseline
the percentage of subjects referred
Time frame: Baseline
Barriers to access exercise
Time frame: Baseline
health-related opinions
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sasha Knowlton, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Metastasis, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity levels (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.