View Clinical Trial (Medical Research Study)
Spousal Relationships and Pain in Metastatic Breast Cancer
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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Breast Cancer |
| Purpose: |
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Ecological Momentary Assessment (EMA) refers to the collection of repeated measurements of
phenomena as they occur in naturalistic settings using hand-held computers. By providing an
EMA of psychosocial variables that influence patient pain and pain behaviors, this study
seeks to characterize the pain experience in metastatic breast cancer from both patients'
and spouses' perspectives.
This study consists of two parts. Part 1 involves developing and pilot testing a hand-held
computer program designed to assess antecedents, behaviors, and consequences of patient
pain, as well as spouse response to pain. Five couples will complete a baseline survey and
carry the hand-held computer for two weeks. They will be interviewed for feedback to refine
the program. Part 2 is a longitudinal assessment of the psychological and relationship
functioning of metastatic breast cancer patients and their spouses. The Optional Procedure
for Part 2 involves using electronic diaries (EDs) to measure the cancer pain experience for
patients with metastatic breast cancer and their spouses.
The specific aims of this study are to: (1) To examine patient pain, spouse response to
patient pain, and patient behaviors in response to pain over the course of 6 months in
couples facing metastatic breast cancer, (2) test the biopsychosocial model of chronic pain
in breast cancer; expanding it to include the influence of patient psychological
functioning, spouse psychological functioning, and relationship functioning, on patient
pain, spouse behaviors, and patient behaviors in response to pain, (3) use ecological
momentary assessment to characterize patient pain, spouse response to patient pain, and
patient behaviors in response to pain.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00386620 |
| Primary Contact: |
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Principal Investigator
Hoda Badr, PhD
M.D. Anderson Cancer Center
Hoda Badr, PhD
Phone: 713-792-5922
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| Backup Contact: |
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N/A |
| Location Contact: |
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Houston, Texas 77030
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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