ClinicalTrials.gov
ClinicalTrials.gov Menu

Spousal Relationships and Pain in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00386620
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : July 7, 2015
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment
Breast Cancer Behavioral: Questionnaire Behavioral: Interview

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 548 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spousal Relationships and Pain in Metastatic Breast Cancer
Study Start Date : October 2004
Actual Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
Survey + ED

Part 1: Survey + Electronic Diaries (ED)

Part 2: 3 Month, 6 Month Survey + ED

Behavioral: Questionnaire
45 minute survey about health, pain and relationships
Behavioral: Interview
Feedback on use of handheld computer electronic diaries (ED).



Primary Outcome Measures :
  1. Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses. [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Pilot of hand-held computers at home for metastatic breast cancer patient and spouses to answer questions about pain and other symptoms. [ Time Frame: 14 Days (Survey Response + 30 Minute Interview) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women diagnosed with metastatic breast cancer and their male spouse or significant other
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386620


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
United States Department of Defense
Investigators
Principal Investigator: Hoda Badr, PhD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00386620     History of Changes
Other Study ID Numbers: 2003-0595
W81XWH-04-1-0425 ( Other Identifier: Department of Defense Breast Cancer Research Program )
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Cancer Control
Spousal Relationships
Questionnaire
Interview
Pain

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