Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386620
Status:
COMPLETED
Last Update Posted:
2015-07-07
First Post:
2006-10-09
Brief Title:
Spousal Relationships and Pain in Metastatic Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Spousal Relationships and Pain in Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W81XWH-04-1-0425 | OTHER | Department of Defense Breast Cancer Research Program | None |