Breast CancerNCT00276822
Improving Communication With Patients With Breast Cancer
A study testing communication intervention in people with Breast Cancer, run by Northwestern University at 1 site in United States.
Trial summary
RATIONALE: An education program based on patients' health communication needs may improve patients' overall healthcare experience and sense of control. PURPOSE: This clinical trial is studying the health communication needs of patients with breast cancer to develop patient education programs. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- communication intervention
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Nov 2006
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
PATIENT CHARACTERISTICS:
- Patients: 30 to 80 years of age
- Family members: 20 to 80 years of age
- Healthcare team members: 20 to 80 years of age
- Must be conversant in English
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
About this study
Official title: Facilitating Caring Communication for People With Cancer: The Case of Breast Cancer
RATIONALE: An education program based on patients' health communication needs may improve patients' overall healthcare experience and sense of control.
PURPOSE: This clinical trial is studying the health communication needs of patients with breast cancer to develop patient education programs.
Read the detailed description
OBJECTIVES:
- Determine patients' health communication needs during the first 6 months of care by interviewing patients with breast cancer (as well as their families, caregivers, and healthcare teams) and observing interactions between patients and oncologists throughout the trajectory of care from initial diagnosis through the initial treatment course.
- Determine patients' health communication needs at the point of bone metastases by interviewing patients with breast cancer (as well as their families, caregivers, and healthcare teams) and observing interactions between patients and oncologists in the Hematology-Oncology Clinic.
- Develop Patient Education Programs to help meet patients' health communication needs by conveying information about essential elements of cancer care in a clear and consistent manner, thus allowing clinicians to focus more attention on answering questions, engaging in counseling, and responding to emotional issues.
- Create a Patient Education Program that models effective strategies for asking questions and expressing concerns and needs for symptom control (i.e., pain, anxiety, depression).
- Develop Patient Narrative Videos, with women identified by their providers, to provide members of the healthcare team with a better understanding of the patient experience and issues that arise for patients outside the formal health care setting.
- Conduct a pilot test to determine whether the Patient Education Programs affect patients' experience of care, sense of control, and perceptions of caring communication, as well as knowledge, satisfaction, anxiety, depression, pain, and self-reported health.
- Determine patient and family response to Patient Narrative Videos and healthcare team response to Patient Narrative Videos and Patient Education Programs.
OUTLINE: This is a pilot, multicenter study.
A visit between the patient and his/her oncologist and healthcare team is videorecorded. Patients, family members, caregivers, and healthcare team members then undergo a 10-minute interview. Patients then undergo a 5-minute follow-up interview once every 2 weeks for 6 months. Some patients may participate in a one-time group discussion.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- communication intervention
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication interventionOther
Patient Education Programs to include surveys, questionnaires, interviews, and videos.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Patient Education Programs on patient experience
Measured: At baseline and at 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startOct 2005
- Primary completionNov 2006
Why it stopped: Preliminary findings did not support purpose.
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 Northwestern UniversityThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gregory Makoul, PhD, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276822
- Sponsor's protocol ID
- NU 05B4
- Other IDs
- P30CA060553, NU-05B4, NU-IRB-0608-011, STU00018976
- Status last verified
- Jun 2012
- First submitted
- 12 Jan 2006
- Last updated
- 11 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Caring Communication for People With Cancer: The Case of Breast Cancer
- ClinicalTrials.gov ID
- NCT00276822
- Acronym / sponsor ID
- NU 05B4
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary findings did not support purpose.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2005
- Primary completion
- Nov 2006 (actual)
- First posted
- 13 Jan 2006 (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: An education program based on patients' health communication needs may improve patients' overall healthcare experience and sense of control.
PURPOSE: This clinical trial is studying the health communication needs of patients with breast cancer to develop patient education programs.
Detailed description
OBJECTIVES:
- Determine patients' health communication needs during the first 6 months of care by interviewing patients with breast cancer (as well as their families, caregivers, and healthcare teams) and observing interactions between patients and oncologists throughout the trajectory of care from initial diagnosis through the initial treatment course.
- Determine patients' health communication needs at the point of bone metastases by interviewing patients with breast cancer (as well as their families, caregivers, and healthcare teams) and observing interactions between patients and oncologists in the Hematology-Oncology Clinic.
- Develop Patient Education Programs to help meet patients' health communication needs by conveying information about essential elements of cancer care in a clear and consistent manner, thus allowing clinicians to focus more attention on answering questions, engaging in counseling, and responding to emotional issues.
- Create a Patient Education Program that models effective strategies for asking questions and expressing concerns and needs for symptom control (i.e., pain, anxiety, depression).
- Develop Patient Narrative Videos, with women identified by their providers, to provide members of the healthcare team with a better understanding of the patient experience and issues that arise for patients outside the formal health care setting.
- Conduct a pilot test to determine whether the Patient Education Programs affect patients' experience of care, sense of control, and perceptions of caring communication, as well as knowledge, satisfaction, anxiety, depression, pain, and self-reported health.
- Determine patient and family response to Patient Narrative Videos and healthcare team response to Patient Narrative Videos and Patient Education Programs.
OUTLINE: This is a pilot, multicenter study.
A visit between the patient and his/her oncologist and healthcare team is videorecorded. Patients, family members, caregivers, and healthcare team members then undergo a 10-minute interview. Patients then undergo a 5-minute follow-up interview once every 2 weeks for 6 months. Some patients may participate in a one-time group discussion.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 80 years
- 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 |
|---|---|---|
| communication interventionPatient Education Programs to include surveys, questionnaires, interviews, and videos. | Other | – |
Primary outcome
Effect of Patient Education Programs on patient experience
Time frame: At baseline and at 2 month follow-up
Results and safety
The study was stopped early (reason given: Preliminary findings did not support purpose.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
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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.
Gregory Makoul, PhD study chair
Robert H. Lurie Cancer 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 communication intervention in people with Breast Cancer, run by Northwestern University 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: stopped early, as of the sponsor's last update on 11 Jun 2012. 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: Preliminary findings did not support purpose.). 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?
Effect of Patient Education Programs on patient experience (time frame: At baseline and at 2 month follow-up). 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 Jun 2012.