Spousal Relationships and Pain in Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00386620
First received: October 9, 2006
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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 Intervention
Breast Cancer
Behavioral: Questionnaire
Behavioral: Interview

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spousal Relationships and Pain in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 622
Study Start Date: October 2004
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386620

Contacts
Contact: Hoda Badr, PhD 713-792-5922

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Hoda Badr, PhD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Hoda Badr, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00386620     History of Changes
Other Study ID Numbers: 2003-0595, W81XWH-04-1-0425
Study First Received: October 9, 2006
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014