AzTrials
AzTrials

Breast CancerNCT00770055

Internet Use Among Women With Recurrent Metastatic Breast Cancer

A study testing medical chart review, questionnaire administration and survey administration in people with Breast Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
medical chart review, questionnaire administration and survey administration
Type of treatment
Surgery or procedure
How many people
70 participants
Where
1 siteUnited States
Study dates
Nov 2001to Jan 2011
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 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: Internet Use Among Women With Recurrent Breast Cancer

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.

Read the 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.

Conditions
Breast Cancer
Being tested
medical chart review, questionnaire administration, survey administration, psychosocial assessment and care
Keywords
stage IV breast cancer, recurrent 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.

  • medical chart reviewOther

  • questionnaire administrationOther

  • survey administrationOther

  • psychosocial assessment and careProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Use of non-internet cancer information

  2. Use of the internet for cancer resources

  3. Use of interactive technologies

  4. Communication with treatment team and family members

  5. Evaluation of internet resources

  6. Changes in internet use over the course of treatment

  7. Cross-sectional associations between patients' internet use and their individual, social, and professional network characteristics

  8. Internet use and changes in patients' beliefs and emotional functioning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2008 (estimated)
  2. Study startNov 2001
  3. Primary completionFeb 2010
  4. Study completionJan 2011

Resources

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
Primary purpose
Health services research
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00770055
Sponsor's protocol ID
CDR0000592835
Other IDs
P30CA072720, CINJ-000102, CINJ-IRB-3879
Status last verified
Jan 2011
First submitted
8 Oct 2008
Last updated
31 Jan 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing medical chart review, questionnaire administration and survey administration in people with Breast Cancer, run by University of Medicine and Dentistry of New Jersey 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: finished, as of the sponsor's last update on 31 Jan 2011. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Use of non-internet cancer information. The study lists 8 primary outcomes in all. 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 31 Jan 2011.

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