Internet Use Among Women With Recurrent Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
medical chart review
questionnaire administration
survey administration
psychosocial assessment and care
Sponsored by

About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of recurrent breast cancer meeting either of the following criteria:
- Newly diagnosed metastatic disease
Recently diagnosed as progressive disease after stable metastatic disease for at least 6 months
Must have received the same treatment for metastatic breast cancer for at least 3 months
- Have received no treatment for progressive disease OR have begun treatment for progressive disease within the past month
- Patient at the Cancer Institute of New Jersey in New Brunswick or Hamilton, New Jersey
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Able to speak and write English
- Free of diseases and cognitive impairments that would interfere with comprehension of the survey instruments or ability to provide informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Sites / Locations
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
Outcomes
Primary Outcome Measures
Use of non-internet cancer information
Use of the internet for cancer resources
Use of interactive technologies
Communication with treatment team and family members
Evaluation of internet resources
Changes in internet use over the course of treatment
Cross-sectional associations between patients' internet use and their individual, social, and professional network characteristics
Internet use and changes in patients' beliefs and emotional functioning
Secondary Outcome Measures
Full Information
NCT ID
NCT00770055
First Posted
October 8, 2008
Last Updated
January 27, 2011
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00770055
Brief Title
Internet Use Among Women With Recurrent Metastatic Breast Cancer
Official Title
Internet Use Among Women With Recurrent Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Gathering information about patients with breast cancer over time may help doctors learn more about a patient's use of the internet to find information about treatment, symptom management, and emotional support.
PURPOSE: This clinical trial is studying internet use among women with recurrent metastatic breast cancer.
Detailed Description
OBJECTIVES:
To document the proportion of women who use the internet to access treatment and symptom management information and to seek emotional support after diagnosis of metastatic recurrent breast cancer.
To evaluate the association of treatment stage and effectiveness with internet use.
To evaluate the association of individual differences in patients' demographics, beliefs, emotional functioning, and social and professional support with internet use.
To evaluate the association of patients' use of the internet to seek resources with their beliefs, emotional functioning, and relationship functioning.
OUTLINE: Patients undergo assessments consisting of paper and pencil questionnaires at four time points. The timing of these assessments is linked to the patient's treatment course and her presumed need to access internet resources for information on cancer, treatment, symptom management, and emotional support. Patients who discontinue regular care at the Cancer Institute of New Jersey site during the course of the study may complete study assessments through phone interviews conducted by a member of the study team.
Patients undergo a baseline survey prior to deciding on a treatment course for their newly progressive disease. Patients complete the first part of the survey to provide information on demographics, beliefs about cancer, mood states, somatic symptoms, and available resources for cancer information and emotional support. Patients complete the second part of the survey, if they have used the internet previously to obtain information and resources about cancer or if they have received cancer information that someone else located on the internet for them, which inquires about patients' internet use, any internet resources they have received from family members, friends, or other people they know, and their own evaluation of these internet resources. Patients undergo the second study assessment after completion of the first course of treatment and prior to initiating course 2 (i.e., 3 to 4 weeks after initiating treatment). The third study assessment occurs within the first 2 weeks after the medical oncologist's first evaluation of treatment response (i.e., 6-9 weeks after initiating treatment). The fourth assessment occurs after the medical oncologist's second evaluation of the patient's response to treatment, following tumor re-staging.
Patients complete several questionnaires during these assessments to provide information about personal characteristics (demographics, physical and psychological well-being, beliefs about cancer and treatment, optimism), social and healthcare networks (perceived social support, social network composition, beliefs about treatment team), and outcomes (use of non-internet cancer information, use of the internet for cancer resources, use of interactive technologies, communication with treatment team and family, evaluation of internet resources).
The following information is extracted from the patients' medical record: stage and node status at primary diagnosis, previous oncology surgeries, previous adjuvant treatments, current menopausal status, treatment at time of recurrence, disease free interval, site(s) of metastasis, and response to current treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, recurrent breast cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
medical chart review
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Other
Intervention Name(s)
survey administration
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Primary Outcome Measure Information:
Title
Use of non-internet cancer information
Title
Use of the internet for cancer resources
Title
Use of interactive technologies
Title
Communication with treatment team and family members
Title
Evaluation of internet resources
Title
Changes in internet use over the course of treatment
Title
Cross-sectional associations between patients' internet use and their individual, social, and professional network characteristics
Title
Internet use and changes in patients' beliefs and emotional functioning
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of recurrent breast cancer meeting either of the following criteria:
Newly diagnosed metastatic disease
Recently diagnosed as progressive disease after stable metastatic disease for at least 6 months
Must have received the same treatment for metastatic breast cancer for at least 3 months
Have received no treatment for progressive disease OR have begun treatment for progressive disease within the past month
Patient at the Cancer Institute of New Jersey in New Brunswick or Hamilton, New Jersey
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Menopausal status not specified
Able to speak and write English
Free of diseases and cognitive impairments that would interfere with comprehension of the survey instruments or ability to provide informed consent
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Toppmeyer, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Internet Use Among Women With Recurrent Metastatic Breast Cancer
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