Breast CancerNCT00937989
Study of Barriers to Beginning and Finishing Treatment for Patients With Breast Cancer
A study testing educational intervention, informational intervention and medical chart review in people with Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help doctors learn more about improving the treatment process and improve patients' quality of life. PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for patients with breast cancer. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- educational intervention, informational intervention and medical chart review
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to May 2011
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed breast cancer
- Stage 0-III disease
- No metastasis or recurrent disease
- Insured with Medi-Cal OR ≥ 65 years old
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- English or Spanish-speaking
- Intending to receive all primary breast cancer treatment at City of Hope
PRIOR CONCURRENT THERAPY:
- No prior therapy for breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: Patient Navigation in Breast Cancer Care; Addressing Barriers to Treatment Initiation, Completion, and Follow Up
RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help doctors learn more about improving the treatment process and improve patients' quality of life.
PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for patients with breast cancer.
Read the detailed description
OBJECTIVES:
- Identify barriers of receiving primary breast cancer treatment for older patients with either Medi-Cal insurance or who are 65 years of age and older.
- Describe steps and processes involved in resolution of barriers to receiving primary breast cancer treatment for these patients.
- Identify barriers of receiving primary breast cancer treatment for patients who are Hispanic with either Medi-Cal insurance or aged 65 years and older.
- Describe steps and processes involved in resolution of barriers to receiving primary breast cancer treatment for these Hispanic patients.
- Describe breast cancer participants' perceptions of Patient Navigation.
- Demonstrate the significant role of a Patient Navigator in identifying and resolving barriers to treatment.
- Increase opportunities for participation of breast cancer patients with either Medi-Cal insurance or who are 65 years of age and older, or who are Hispanic, to breast cancer clinical trials.
- Integrate a patient navigation program within City of Hope designed to support underserved patients during primary treatment for breast cancer.
OUTLINE: For the first 3 months of the study, medical charts are reviewed.
Beginning in month 4, patients are introduced to the Patient Navigator who provides them with telephone and e-mail contact on an Appointment Reminder Card, and develops a plan for eliminating identified barriers and/or addressing immediate concerns. Patients' plans may include contacting others on behalf of the patient, coaching the patient on how to solve a problem, referring to resources within City of Hope (COH) or in the community, and investigating possible solutions. Patients are also oriented to COH's services, open clinical trials, and resources. Navigation of care includes assistance during initial and ongoing evaluations by all cancer specialists, during initiation and completion of all primary treatment, and through the first post-treatment follow up. Patients are contacted weekly for 8 weeks of the study and at least once a month for 9 months.
The Patient Navigator will track identified barriers, processes to resolution, and time required to resolve barriers.
Patients complete questionnaires at baseline, and periodically during study, on socio-demographic, quality of life, resource-use satisfaction, and satisfaction with care and Patient Navigator.
After completion of study intervention, patients continue to receive Patient Navigator support for up to 30 days.
- Conditions
- Breast Cancer
- Being tested
- educational intervention, informational intervention, medical chart review, questionnaire administration, study of socioeconomic and demographic variables
- Keywords
- ductal breast carcinoma in situ, lobular breast carcinoma in situ, male breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
informational interventionOther
Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
medical chart reviewOther
Baseline, 3, 6 and 9 months after starting the study
questionnaire administrationOther
Baseline, 3, 6 and 9 months after starting the study
study of socioeconomic and demographic variablesOther
Baseline, 3, 6 and 9 months after starting the study
quality-of-life assessmentProcedure or surgery
Baseline, 3, 6 and 9 months after starting the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Barrier resolution (information, transportation, appointments, and communication) and time to resolution
Measured: Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
Quality of life (psychological, physical, social, and spiritual well-being)
Measured: Prior to starting treatment and 3, 6 and 9 months after starting the study.
Navigation and care (patient's satisfaction and value, provider's perception of barriers)
Measured: 3, 6 and 9 months after starting the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startNov 2008
- Primary completionMay 2011
- Study completionMay 2011
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.
- More trials run by City of Hope Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rebecca Crane-Okada, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937989
- Sponsor's protocol ID
- 08092
- Other IDs
- P30CA033572, CHNMC-08092, CDR0000629952
- Status last verified
- Jun 2015
- First submitted
- 10 Jul 2009
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Navigation in Breast Cancer Care; Addressing Barriers to Treatment Initiation, Completion, and Follow Up
- ClinicalTrials.gov ID
- NCT00937989
- Acronym / sponsor ID
- 08092
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ, lobular breast carcinoma in situ, male breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 13 Jul 2009 (estimated)
- 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.
RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help doctors learn more about improving the treatment process and improve patients' quality of life.
PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for patients with breast cancer.
Detailed description
OBJECTIVES:
- Identify barriers of receiving primary breast cancer treatment for older patients with either Medi-Cal insurance or who are 65 years of age and older.
- Describe steps and processes involved in resolution of barriers to receiving primary breast cancer treatment for these patients.
- Identify barriers of receiving primary breast cancer treatment for patients who are Hispanic with either Medi-Cal insurance or aged 65 years and older.
- Describe steps and processes involved in resolution of barriers to receiving primary breast cancer treatment for these Hispanic patients.
- Describe breast cancer participants' perceptions of Patient Navigation.
- Demonstrate the significant role of a Patient Navigator in identifying and resolving barriers to treatment.
- Increase opportunities for participation of breast cancer patients with either Medi-Cal insurance or who are 65 years of age and older, or who are Hispanic, to breast cancer clinical trials.
- Integrate a patient navigation program within City of Hope designed to support underserved patients during primary treatment for breast cancer.
OUTLINE: For the first 3 months of the study, medical charts are reviewed.
Beginning in month 4, patients are introduced to the Patient Navigator who provides them with telephone and e-mail contact on an Appointment Reminder Card, and develops a plan for eliminating identified barriers and/or addressing immediate concerns. Patients' plans may include contacting others on behalf of the patient, coaching the patient on how to solve a problem, referring to resources within City of Hope (COH) or in the community, and investigating possible solutions. Patients are also oriented to COH's services, open clinical trials, and resources. Navigation of care includes assistance during initial and ongoing evaluations by all cancer specialists, during initiation and completion of all primary treatment, and through the first post-treatment follow up. Patients are contacted weekly for 8 weeks of the study and at least once a month for 9 months.
The Patient Navigator will track identified barriers, processes to resolution, and time required to resolve barriers.
Patients complete questionnaires at baseline, and periodically during study, on socio-demographic, quality of life, resource-use satisfaction, and satisfaction with care and Patient Navigator.
After completion of study intervention, patients continue to receive Patient Navigator support for up to 30 days.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| educational interventionOccurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study. | Other | – |
| informational interventionOccurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study. | Other | – |
| medical chart reviewBaseline, 3, 6 and 9 months after starting the study | Other | – |
| questionnaire administrationBaseline, 3, 6 and 9 months after starting the study | Other | – |
| study of socioeconomic and demographic variablesBaseline, 3, 6 and 9 months after starting the study | Other | – |
| quality-of-life assessmentBaseline, 3, 6 and 9 months after starting the study | Procedure or surgery | – |
Primary outcome
Barrier resolution (information, transportation, appointments, and communication) and time to resolution
Time frame: Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
Quality of life (psychological, physical, social, and spiritual well-being)
Time frame: Prior to starting treatment and 3, 6 and 9 months after starting the study.
Navigation and care (patient's satisfaction and value, provider's perception of barriers)
Time frame: 3, 6 and 9 months after starting the study.
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 8 Jun 2015.
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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.
Rebecca Crane-Okada, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, informational intervention and medical chart review in people with Breast Cancer, run by City of Hope Medical 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?
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 8 Jun 2015. 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?
Barrier resolution (information, transportation, appointments, and communication) and time to resolution (time frame: Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.). The study lists 3 primary outcomes in all. 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 8 Jun 2015.