Breast Cancer Clinical Trial
Official title:
The NCl Community Cancer Center Program Patients Reported Symptom Surveillance and Disparities Study
Verified date | May 23, 2019 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- Cancer and cancer treatments can cause symptoms and side effects. Pain, fatigue, and
emotional distress are three common symptoms. Accurate reporting of these symptoms can
improve treatment methods and outcomes. Even though symptom reporting is important to
treatment, there is no method to collect and compare patient data from multiple cancer care
centers. Researchers want to develop a method for collecting cancer patient symptom
information from multiple centers. This method may help improve cancer treatment at hospitals
and other care centers.
Objectives:
- To collect patient-reported symptom information from multiple cancer care centers.
Eligibility:
- Individuals at least 21 years of age who were treated for breast or colon cancer in the
past year.
- Participants will come from one of the participating cancer care centers.
Design:
- Participants will answer a short questionnaire about their symptoms during cancer
treatment. Questions will ask about symptom severity and experiences. Other questions
will ask how well the doctors and nurses managed the symptoms.
- Participant responses will be compared with other medical and personal information. This
information may include cancer type, age at diagnosis, and type of treatment.
- Treatment will not be provided as part of this study.
Status | Completed |
Enrollment | 2517 |
Est. completion date | May 23, 2019 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
- INCLUSION CRITERIA: The respondent universe will consist of all cancer patients at the 16 participating NCCCP Cancer Centers who satisfy the following conditions: - Diagnosed with Stage I-III breast or colon cancer as first primary cancer between February 2011 and January 2013 - Eligible for one of the RQRS breast or colon Quality of Care Indicators - Age of 21 or older - Not known to be deceased at the time of contact The NCCCP is a network of 30 community hospitals in 22 states supporting cancer research and enhancing cancer care for patients close to home. Most cancer patients in the U.S. are diagnosed and treated at community hospitals; not in NCI Comprehensive Cancer Centers where much research is conducted. The National Cancer Institute Community Cancer Centers Program (NCCCP) is expanding cancer research and bringing advanced cancer treatments to patients in community hospitals in rural, suburban and inner-city areas. This study is being conducted at the 16 pilot NCCCP sites that first entered the program in 2007. All 16 participate in RQRS. These 16 pilot sites are located in 14 states throughout the United States. EXCLUSION CRITERIA: - Patients will be excluded for the following reasons:Patient is ineligible for one of the 5 RQRS breast or colon quality indicators - Patient is deceased at the time of sampling - Patient has Stage IV cancer |
Country | Name | City | State |
---|---|---|---|
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Northside Hospital | Atlanta | Georgia |
United States | Our Lady of the Lake/ Mary Bird Perkins | Baton Rouge | Louisiana |
United States | Billings Clinical Cancer Center | Billings | Montana |
United States | Penrose Cancer Center | Colorado Springs | Colorado |
United States | CHI, St. Fancis | Grand Island | Nebraska |
United States | Hartford Hospital | Hartford | Connecticut |
United States | CHI, Good Samaritan | Kearney | Nebraska |
United States | Ascension Health Systems | Milwaukee | Wisconsin |
United States | Christiana Care Health Services | Newark | Delaware |
United States | St. Joseph's Orange | Orange | California |
United States | St. Joseph's/Candler Health System | Savannah | Georgia |
United States | Sanford Health | Sioux Falls | South Dakota |
United States | Spartanburg Regional Hospital | Spartanburg | South Carolina |
United States | The Cancer Institute Catholic Health Initiatives | Towson | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Anderson KO, Green CR, Payne R. Racial and ethnic disparities in pain: causes and consequences of unequal care. J Pain. 2009 Dec;10(12):1187-204. doi: 10.1016/j.jpain.2009.10.002. Review. — View Citation
Arora NK, Reeve BB, Hays RD, Clauser SB, Oakley-Girvan I. Assessment of quality of cancer-related follow-up care from the cancer survivor's perspective. J Clin Oncol. 2011 Apr 1;29(10):1280-9. doi: 10.1200/JCO.2010.32.1554. Epub 2011 Feb 28. — View Citation
Banna GL, Collovà E, Gebbia V, Lipari H, Giuffrida P, Cavallaro S, Condorelli R, Buscarino C, Tralongo P, Ferraù F. Anticancer oral therapy: emerging related issues. Cancer Treat Rev. 2010 Dec;36(8):595-605. doi: 10.1016/j.ctrv.2010.04.005. Epub 2010 Jun 8. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PRO symptom measurement | Complete reporting of symptoms | 4-9 months post treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |