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Spousal Relationships and Pain in Metastatic Breast Cancer


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Open (Enrolling)
Both
Breast Cancer

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Trial Information

Spousal Relationships and Pain in Metastatic Breast Cancer


Part 1:

Women with metastatic breast cancer will be asked to take part in the study. Project staff
will review patients' medical records to determine their eligibility for the study. Eligible
patients will be approached by a project staff member when they begin treatment for
metastatic disease.

By agreeing to participate, you are agreeing to allow the study staff to contact your
spouse. Spouses who are not present at the time patients are consented will not be asked to
participate. Interested patients may still participate in this study even if their spouse
is unwilling or unable to participate.

A project staff member will show participants how to use hand-held computers. Learning to
use the computers does not require previous computer experience. Participants will take the
computers home and, when signaled by the computer, answer a brief series of questions about
how they are feeling physically and emotionally at that particular moment.

Participants will be prompted to answer questions 6 times a day, for 14 days after starting
treatment. It should take about 2 minutes to answer the questions each time.

Upon completion, participants will be interviewed separately in person or on the telephone
for feedback about using the computer. The interview should take about 30 minutes.

At the time participants are consented, they will also be asked to complete several
questionnaires about their health, pain, and their relationship. It will take about 45
minutes to complete all of the questionnaires. Participants may complete the questionnaires
while waiting for their clinic appointments, or they may take the questionnaires home,
complete them, and return them in a pre-stamped envelope.

A project staff member will review patients' medical records to collect medical information
relevant to this study.

All answers given by participants will be kept private.

This is an investigational study. A total of 5 patients and 5 spouses will be asked to
participate. All we be enrolled at M. D. Anderson.

Part 2:

Women with metastatic breast cancer will be asked to take part in the study. Project staff
will review patients' medical records to determine their eligibility for the study. Eligible
patients will be approached by a project staff member when they begin treatment for
metastatic disease.

By agreeing to participate, you are agreeing to allow the study staff to contact your
spouse. Spouses who are not present at the time patients are consented will be contacted by
phone, to find out if they are interested in participating in this study.

Patients and spouses who are interested in participating will be asked to complete several
questionnaires about their health, pain, and their relationship. It will take about 45
minutes to complete all of the questionnaires. Participants in this study may complete the
questionnaires while waiting for their clinic appointments, or they may take the
questionnaires home, complete them, and return them in a pre-stamped envelope.

Both patients and their spouses will be asked to complete the same questionnaires 3 months
after completing the first questionnaire, and then again 3 months later. Any patient whose
spouse does not wish to participate will not be asked to complete these additional
questionnaires.

Attempts will be made to give these questionnaires during routine clinic appointments so
that the questionnaires can be completed while in the waiting room. If appointments do not
occur at the same time as the questionnaires are scheduled to be completed or clinic time
does not permit, patients and spouses will be mailed the questionnaire packets and asked to
return them in self-addressed stamped envelopes.

A project staff member will review patients' medical records to collect medical information
relevant to this study.

All answers given by participants will be kept private.

This is an investigational study. Up to 622 individuals (311 patients and 311 spouses) will
be asked to participate in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. For Patients: Being a female patient diagnosed with metastatic breast cancer.

2. For Patients: Initiating treatment for metastatic breast cancer

3. For Patients: Having and ECOG Performance Status Score of 2 or less

4. For Spouses: Being the male spouse or significant other of a female patient diagnosed
with metastatic breast cancer

5. For Spouses: Having the patient's consent to be contacted

6. For Patients and Spouses: Having the ability to read and speak English well enough to
understand the consent form and complete the questionnaires

7. For Patients and Spouses: Being able to provide informed consent

Exclusion Criteria:

1. For Patients and Spouses: Not being able to provide informed consent.

2. For Patients: Rating average pain as 0 on the BPI

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses.

Outcome Time Frame:

6 Months

Safety Issue:

No

Principal Investigator

Hoda Badr, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2003-0595

NCT ID:

NCT00386620

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Cancer Control
  • Spousal Relationships
  • Questionnaire
  • Interview
  • Pain
  • Breast Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030