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Spousal Relationships and Pain in Metastatic Breast Cancer

NCT00386620 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 548

Last updated 2015-07-07

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Questionnaire

45 minute survey about health, pain and relationships

BEHAVIORAL

Interview

Feedback on use of handheld computer electronic diaries (ED).

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Hoda Badr, PhD · M.D. Anderson Cancer Center

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00386620 on ClinicalTrials.gov