Health Status UnknownNCT03412370
Questionnaires and Cognitive Assessments Following Mammography
An observational study of Health Status Unknown, run by University of Southern California at 1 site in United States.
Trial summary
This pilot research trial studies how well questionnaires and cognitive assessments work in tracking patient symptoms following mammography. Gathering information over time through questionnaires and cognitive tests about symptoms patients may experience after a mammogram may help doctors understand the cause of these… Read more about this study
- Who is it for?
- Ages 21 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Status Unknown
- What is being tested?
- Cognitive Assessment and Questionnaire Administration
- Type of treatment
- Injection or infusion
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2017to 21 Sep 2017
- 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 21 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who have just completed a mammography
Who may be able to join
- Mammography Breast Imaging Reporting and Data System (BI-RAD) 4-5; or BI-RAD 1-2
- Fluent in English
- Access to Internet
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- Prior abnormal mammography
- Prior cancer diagnosis
- Prior treatment with chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Symptom Tracking in Women Following Mammography
This pilot research trial studies how well questionnaires and cognitive assessments work in tracking patient symptoms following mammography. Gathering information over time through questionnaires and cognitive tests about symptoms patients may experience after a mammogram may help doctors understand the cause of these symptoms.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of Internet-based cognitive assessments as preliminary data prior to larger clinical trial.
OUTLINE:
Patients complete questionnaires and cognitive assessments over 45-60 minutes within 3 weeks following mammography and at about 3 months in patients for whom biopsy is not required, before biopsy and at about 3 months in patients for whom biopsy is required, and at 4-6 weeks after first chemotherapy infusion in patients receiving chemotherapy.
- Conditions
- Health Status Unknown
- Being tested
- Cognitive Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive AssessmentOther
Complete cognitive assessments
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaires, cognitive assessment) | Patients complete questionnaires and cognitive assessments over 45-60 minutes within 3 weeks following mammography and at about 3 months in patients for whom biopsy is not required, before biopsy and at about 3 months in patients for whom biopsy is required, and at 4-6 weeks after first chemotherapy infusion in patients receiving chemotherapy. Receives: Other: Cognitive Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients invited who agree to participate
Number of patients invited will be reported.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start27 Jul 2017
- Primary completion21 Sep 2017
- Study completion21 Sep 2017
Why it stopped: Insufficient Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Status UnknownStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joan Broderick, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412370
- Sponsor's protocol ID
- 1B-17-2
- Other IDs
- NCI-2017-02234, 1B-17-2, P30CA014089
- Status last verified
- Jan 2019
- First submitted
- 19 Jan 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Tracking in Women Following Mammography
- ClinicalTrials.gov ID
- NCT03412370
- Acronym / sponsor ID
- 1B-17-2
- Conditions
- Health Status Unknown
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient Accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 21 Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 26 Jan 2018 (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.
This pilot research trial studies how well questionnaires and cognitive assessments work in tracking patient symptoms following mammography. Gathering information over time through questionnaires and cognitive tests about symptoms patients may experience after a mammogram may help doctors understand the cause of these symptoms.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of Internet-based cognitive assessments as preliminary data prior to larger clinical trial.
OUTLINE:
Patients complete questionnaires and cognitive assessments over 45-60 minutes within 3 weeks following mammography and at about 3 months in patients for whom biopsy is not required, before biopsy and at about 3 months in patients for whom biopsy is required, and at 4-6 weeks after first chemotherapy infusion in patients receiving chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaires, cognitive assessment) | – | Other: Cognitive Assessment, Other: Questionnaire AdministrationPatients complete questionnaires and cognitive assessments over 45-60 minutes within 3 weeks following mammography and at about 3 months in patients for whom biopsy is not required, before biopsy and at about 3 months in patients for whom biopsy is required, and at 4-6 weeks after first chemotherapy infusion in patients receiving chemotherapy. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have just completed a mammography
Key inclusion criteria (4 listed)
- Mammography Breast Imaging Reporting and Data System (BI-RAD) 4-5; or BI-RAD 1-2
- Fluent in English
- Access to Internet
- Ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (3 listed)
- Prior abnormal mammography
- Prior cancer diagnosis
- Prior treatment with chemotherapy
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 |
|---|---|---|
| Cognitive AssessmentComplete cognitive assessments | Other | Observational (questionnaires, cognitive assessment) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (questionnaires, cognitive assessment) |
Primary outcome
Number of patients invited who agree to participate
Time frame: Up to 2 years
Number of patients invited will be reported.
Results and safety
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
Related trials for Health Status Unknown
Active, not recruiting
Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome
Conditions Influencing Health Status, Healthy
Active, not recruiting
Patients Navigators in Facilitating Weight Management in Obese Participants
Health Status Unknown, Obesity
Active, not recruiting
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
Body Mass Index 25 or Greater, BRCA1 Gene Mutation
Active, not recruiting
Your Health Matters! (Tu Salud ¡Si Cuenta!): Promoting Healthy Lifestyles in Latino Families
Family Member, Health Status Unknown
Active, not recruiting
Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
Health Status Unknown, Elevated PSA
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.
Joan Broderick, Ph.D. principal investigator
University of Southern California
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 Health Status Unknown, run by University of Southern California 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 3 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: stopped early, as of the sponsor's last update on 25 Jan 2019. 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 was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
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?
Number of patients invited who agree to participate (time frame: Up to 2 years). 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 25 Jan 2019.