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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00770055 |
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.
Condition | Intervention |
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Breast Cancer |
Other: medical chart review Other: questionnaire administration Other: survey administration Procedure: psychosocial assessment and care |
Study Type: | Interventional |
Study Design: | Health Services Research |
Official Title: | Internet Use Among Women With Recurrent Breast Cancer |
Estimated Enrollment: | 70 |
Study Start Date: | November 2001 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of recurrent breast cancer meeting either of the following criteria:
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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New Jersey | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 |
Principal Investigator: | Linda Patrick-Miller, PhD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000592835, CINJ-000102, CINJ-IRB-3879 |
Study First Received: | October 8, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00770055 History of Changes |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |