Internet Use Among Women With Recurrent Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00770055
First received: October 8, 2008
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

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
Breast Cancer
Other: medical chart review
Other: questionnaire administration
Other: survey administration
Procedure: psychosocial assessment and care

Study Type: Interventional
Study Design: Primary Purpose: Health Services Research
Official Title: Internet Use Among Women With Recurrent Breast Cancer

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Use of non-internet cancer information [ Designated as safety issue: No ]
  • Use of the internet for cancer resources [ Designated as safety issue: No ]
  • Use of interactive technologies [ Designated as safety issue: No ]
  • Communication with treatment team and family members [ Designated as safety issue: No ]
  • Evaluation of internet resources [ Designated as safety issue: No ]
  • Changes in internet use over the course of treatment [ Designated as safety issue: No ]
  • Cross-sectional associations between patients' internet use and their individual, social, and professional network characteristics [ Designated as safety issue: No ]
  • Internet use and changes in patients' beliefs and emotional functioning [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: November 2001
Study Completion Date: January 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770055

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Deborah Toppmeyer, MD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Deborah Toppmeyer, MD, Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier: NCT00770055     History of Changes
Other Study ID Numbers: CDR0000592835, P30CA072720, CINJ-000102, CINJ-IRB-3879
Study First Received: October 8, 2008
Last Updated: January 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014