Breast CancerNCT00386620
Spousal Relationships and Pain in Metastatic Breast Cancer
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaire and Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 548 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women diagnosed with metastatic breast cancer and their male spouse or significant other
Who may be able to join
- 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
Who cannot join
- For Patients and Spouses: Not being able to provide informed consent.
- For Patients: Rating average pain as 0 on the BPI
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Questionnaire, Interview
- Keywords
- Breast Cancer, Cancer Control, Spousal Relationships, Questionnaire, Interview, Pain
- Medical subject headings
- Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
45 minute survey about health, pain and relationships
InterviewBehavioural
Feedback on use of handheld computer electronic diaries (ED).
| Study group | Role | What they receive |
|---|---|---|
| Survey + ED | Part 1: Survey + Electronic Diaries (ED)
Part 2: 3 Month, 6 Month Survey + ED Receives: Behavioral: Questionnaire; Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses.
Measured: 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.
Measured: 14 Days (Survey Response + 30 Minute Interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startOct 2004
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Hoda Badr, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386620
- Sponsor's protocol ID
- 2003-0595
- Other IDs
- W81XWH-04-1-0425
- Status last verified
- Jul 2015
- First submitted
- 9 Oct 2006
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spousal Relationships and Pain in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00386620
- Acronym / sponsor ID
- 2003-0595
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Cancer Control, Spousal Relationships, Questionnaire, Interview, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Oct 2004
- Primary completion
- Jul 2015 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey + ED | – | Behavioral: Questionnaire, Behavioral: InterviewPart 1: Survey + Electronic Diaries (ED) Part 2: 3 Month, 6 Month Survey + ED |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women diagnosed with metastatic breast cancer and their male spouse or significant other
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- For Patients and Spouses: Not being able to provide informed consent.
- For Patients: Rating average pain as 0 on the BPI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire45 minute survey about health, pain and relationships | Behavioural | Survey + ED |
| InterviewFeedback on use of handheld computer electronic diaries (ED). | Behavioural | Survey + ED |
Primary outcome
Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses.
Time frame: 6 Months
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoda Badr, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses. (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.