Internet Use Among Women With Recurrent Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Internet Use Among Women With Recurrent Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770055
• Other study ID #: CDR0000592835
• Secondary ID: P30CA072720CINJ-
• Status: Completed
• Phase: N/A
• First received: October 8, 2008
• Last updated: January 27, 2011
• Start date: November 2001
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• medical chart review

• questionnaire administration

• survey administration

Procedure:
• psychosocial assessment and care

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of non-internet cancer information			No
Primary	Use of the internet for cancer resources			No
Primary	Use of interactive technologies			No
Primary	Communication with treatment team and family members			No
Primary	Evaluation of internet resources			No
Primary	Changes in internet use over the course of treatment			No
Primary	Cross-sectional associations between patients' internet use and their individual, social, and professional network characteristics			No
Primary	Internet use and changes in patients' beliefs and emotional functioning			No