NCT00386620

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
548

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

10.8 years

First QC Date

October 9, 2006

Last Update Submit

July 6, 2015

Conditions

Breast Cancer

Keywords

Breast CancerCancer ControlSpousal RelationshipsQuestionnaireInterviewPain

Outcome Measures

Primary Outcomes (1)

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

    6 Months

Secondary Outcomes (1)

  • Pilot of hand-held computers at home for metastatic breast cancer patient and spouses to answer questions about pain and other symptoms.

    14 Days (Survey Response + 30 Minute Interview)

Study Arms (1)

Survey + ED

Part 1: Survey + Electronic Diaries (ED) Part 2: 3 Month, 6 Month Survey + ED

Behavioral: QuestionnaireBehavioral: Interview

Interventions

QuestionnaireBEHAVIORAL

45 minute survey about health, pain and relationships

Survey + ED
InterviewBEHAVIORAL

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

Survey + ED

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women diagnosed with metastatic breast cancer and their male spouse or significant other

You may qualify if:

  • For Patients: Being a female patient diagnosed with metastatic breast cancer.
  • For Patients: Initiating treatment for metastatic breast cancer
  • For Patients: Having and ECOG Performance Status Score of 2 or less
  • For Spouses: Being the male spouse or significant other of a female patient diagnosed with metastatic breast cancer
  • For Spouses: Having the patient's consent to be contacted
  • For Patients and Spouses: Having the ability to read and speak English well enough to understand the consent form and complete the questionnaires
  • For Patients and Spouses: Being able to provide informed consent

You may not qualify if:

  • For Patients and Spouses: Not being able to provide informed consent.
  • For Patients: Rating average pain as 0 on the BPI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsPain

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Hoda Badr, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2006

First Posted

October 11, 2006

Study Start

October 1, 2004

Primary Completion

July 1, 2015

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

US(1)