NCT01547845

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,517

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 23, 2019

First QC Date

March 6, 2012

Last Update Submit

May 24, 2019

Conditions

Keywords

DisparitiesPatient Reported OutcomesSymptomsSymptom Surveillance

Outcome Measures

Primary Outcomes (1)

  • PRO symptom measurement

    Complete reporting of symptoms

    4-9 months post treatment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

St. Joseph's Orange

Orange, California, 92868, United States

Location

Penrose Cancer Center

Colorado Springs, Colorado, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Christiana Care Health Services

Newark, Delaware, United States

Location

Northside Hospital

Atlanta, Georgia, 30042, United States

Location

St. Joseph's/Candler Health System

Savannah, Georgia, United States

Location

Our Lady of the Lake/ Mary Bird Perkins

Baton Rouge, Louisiana, 70806, United States

Location

The Cancer Institute Catholic Health Initiatives

Towson, Maryland, 21204, United States

Location

Billings Clinical Cancer Center

Billings, Montana, United States

Location

CHI, St. Fancis

Grand Island, Nebraska, 68803, United States

Location

CHI, Good Samaritan

Kearney, Nebraska, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105-1556, United States

Location

Spartanburg Regional Hospital

Spartanburg, South Carolina, 29303, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57117, United States

Location

Ascension Health Systems

Milwaukee, Wisconsin, 53211, United States

Location

Related Publications (3)

  • 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.

    PMID: 21357781BACKGROUND
  • Banna GL, Collova E, Gebbia V, Lipari H, Giuffrida P, Cavallaro S, Condorelli R, Buscarino C, Tralongo P, Ferrau 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.

    PMID: 20570443BACKGROUND
  • 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.

    PMID: 19944378BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Kathleen Castro, R.N.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 8, 2012

Study Start

February 10, 2012

Study Completion

May 23, 2019

Last Updated

May 28, 2019

Record last verified: 2019-05-23

Locations