Breast CancerNCT01392066
Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis
An observational study of Breast Cancer, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to describe psychosocial adjustment in patients with breast cancer and their cohabiting partners/spouses throughout the cancer trajectory, to study mutual influences of the partner on the patient and vice versa, and to identify risk and protective factors that influence the adjustment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,584 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2011to Oct 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: nationwide, population-based cohort of women diagnosed with breast cancer and their male cohabiting partner/spouse
Who may be able to join
- For patients: being a female patient diagnosed with primary breast cancer within the last four months
- For patients: cohabiting with a male partner/spouse
- For partners: being the male cohabiting partner/spouse of a patient diagnosed with primary breast cancer within the last four months
Who cannot join
- For patients: previous diagnosis of breast cancer or breast cancer relapse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.
The purpose of this study is to describe psychosocial adjustment in patients with breast cancer and their cohabiting partners/spouses throughout the cancer trajectory, to study mutual influences of the partner on the patient and vice versa, and to identify risk and protective factors that influence the adjustment process in both patients and partners. The overall aim is to generate knowledge that helps enables us to integrate the partners' needs, problems and resources in treatment and rehabilitation of breast cancer patients.
Read the detailed description
Breast cancer is a major life event. A patient's experience of breast cancer may depend heavily on her intimate partner. However, both patients and partners may experience depressed mood or other psychosocial adjustment problems. Individual and relationship factors, such as the couple's joint efforts to deal with the cancer experience, are likely to contribute to their psychosocial adjustment. More knowledge is needed on the adjustment problems patients and partners experience and how they deal with them.
The study investigates the following research questions:
- Which psychosocial adjustment problems do patients and partners experience throughout the cancer trajectory?
- To what extent do the patient's psychosocial adjustment problems influence the partner's psychosocial adjustment problems and vice versa?
- Which factors are associated with psychosocial adjustment problems?
- How do different strategies of dyadic coping influence the psychosocial adjustment of both the patient and the partner?
A prospective, population-based cohort will be established of women diagnosed with breast cancer in Denmark and their partners. The study combines questionnaire data and data from nationwide clinical and administrative registries.
An invitation letter and study material will be sent to patients by mail. Patients will be asked to invite their partner to participate in the study. Only couples in which both the patient and the partner wish to participate will be asked to complete the questionnaire at 5 and 12 months of follow-up.
Up to 3000 couples (3000 patients and 3000 partners) will be asked to participate in the study during the one year inclusion period.
- Conditions
- Breast Cancer
- Being tested
- questionnaire
- Keywords
- breast neoplasms, spouses/partners, couples, interpersonal relations, psychosocial adjustment, psychological adaptation, depression, quality of life, dyadic coping, coping behavior, cohort, questionnaire
- Medical subject headings
- Breast Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireBehavioural
Both the patient and the partner/spouse fill out a questionnaire that assesses their psychosocial adjustment. Time for completion is ca. 30 minutes.
The questionnaire is administered at baseline and 5- and 12-months follow up.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients and their partners | Patients with breast cancer and their cohabiting partners/spouses Receives: Behavioral: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
self-report questionnaire SF-36
Measured: baseline
quality of life
self-report questionnaire SF-36
Measured: 5-months follow up
quality of life
self-report questionnaire SF-36
Measured: 12-months follow up
depressive symptoms
self-report questionnaire CES-D
Measured: baseline
depressive symptoms
self-report questionnaire CES-D
Measured: 5-months follow up
depressive symptoms
self-report questionnaire CES-D
Measured: 12-months follow up
dyadic coping
self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire
Measured: baseline
dyadic coping
self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire
Measured: 5-months follow up
dyadic coping
self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire
Measured: 12-months follow up
Secondary outcomes (22)
illness perceptions
self-report questionnaire Brief-Illness Perception Questionnaire
Measured: baseline
use of antidepressants
registry information
Measured: 12-months follow up
work ability
self-report item
Measured: baseline
work ability
self-report item
Measured: 5-months follow up
work ability
self-report item
Measured: 12-months follow up
sexual functioning
self-report items (PROMIS item bank)
Measured: baseline
sexual functioning
self-report items (PROMIS item bank)
Measured: 5-months follow up
sexual functioning
self-report items (PROMIS item bank)
Measured: 12-months follow up
body image
self-report questionnaire Body Image Scale
Measured: baseline
body image
self-report questionnaire Body Image Scale
Measured: 5-months follow up
body image
self-report questionnaire Body Image Scale
Measured: 12-months follow up
relationship functioning
self-report items; quality of relationship and intimacy
Measured: baseline
relationship functioning
self-report items; quality of relationship and intimacy
Measured: 5-months follow up
relationship functioning
self-report items; quality of relationship and intimacy
Measured: 12-months follow up
symptom experience
self-report questionnaire BCPT Eight Symptom Scale
Measured: baseline
symptom experience
self-report questionnaire BCPT Eight Symptom Scale
Measured: 5-months follow up
symptom experience
self-report questionnaire BCPT Eight Symptom Scale
Measured: 12-months follow up
partner's involvement in breast cancer
self-report questionnaire
Measured: baseline
partner's involvement in breast cancer
self-report questionnaire
Measured: 5-months follow up
partner's involvement in breast cancer
self-report questionnaire
Measured: 12-months follow up
dimensions of sleep
self-report questionnaire MOS sleep measure
Measured: 5-months follow up
dimensions of sleep
self-report questionnaire MOS sleep measure
Measured: 12-months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2013
- Study completionOct 2013
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 University of Southern DenmarkThe 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
- 1,584 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, University of Groningen, Copenhagen University Hospital, Rigshospitalet, Herlev Hospital
- Responsible party
- Principal investigator, Nina Rottmann, University of Southern Denmark
- Investigators
- Dorte Gilså Hansen, MD, PhD, Study chair, Research Unit of General Practice, Institute of Public Health, University of Southern DenmarkChristoffer Johansen, MD, PhD, DMSc, Study chair, Institute of Cancer Epidemiology, Danish Cancer SocietyMariet Hagedoorn, MSc, PhD, Study chair, University Medical Center GroningenNina Rottmann, MSc, Principal investigator, Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392066
- Sponsor's protocol ID
- SDU-NFK-FK-2011
- Other IDs
- R40-A1920, 2010-41-5193, 2012-41-0901
- Status last verified
- Apr 2014
- First submitted
- 5 Jul 2011
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT01392066
- Acronym / sponsor ID
- SDU-NFK-FK-2011
- Conditions
- Breast Cancer
- Keywords
- breast neoplasms, spouses/partners, couples, interpersonal relations, psychosocial adjustment, psychological adaptation, depression, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,584 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Cancer Society, University of Groningen, Copenhagen University Hospital, Rigshospitalet, Herlev Hospital
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 Jul 2011 (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.
The purpose of this study is to describe psychosocial adjustment in patients with breast cancer and their cohabiting partners/spouses throughout the cancer trajectory, to study mutual influences of the partner on the patient and vice versa, and to identify risk and protective factors that influence the adjustment process in both patients and partners. The overall aim is to generate knowledge that helps enables us to integrate the partners' needs, problems and resources in treatment and rehabilitation of breast cancer patients.
Detailed description
Breast cancer is a major life event. A patient's experience of breast cancer may depend heavily on her intimate partner. However, both patients and partners may experience depressed mood or other psychosocial adjustment problems. Individual and relationship factors, such as the couple's joint efforts to deal with the cancer experience, are likely to contribute to their psychosocial adjustment. More knowledge is needed on the adjustment problems patients and partners experience and how they deal with them.
The study investigates the following research questions:
- Which psychosocial adjustment problems do patients and partners experience throughout the cancer trajectory?
- To what extent do the patient's psychosocial adjustment problems influence the partner's psychosocial adjustment problems and vice versa?
- Which factors are associated with psychosocial adjustment problems?
- How do different strategies of dyadic coping influence the psychosocial adjustment of both the patient and the partner?
A prospective, population-based cohort will be established of women diagnosed with breast cancer in Denmark and their partners. The study combines questionnaire data and data from nationwide clinical and administrative registries.
An invitation letter and study material will be sent to patients by mail. Patients will be asked to invite their partner to participate in the study. Only couples in which both the patient and the partner wish to participate will be asked to complete the questionnaire at 5 and 12 months of follow-up.
Up to 3000 couples (3000 patients and 3000 partners) will be asked to participate in the study during the one year inclusion period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients and their partners | – | Behavioral: questionnairePatients with breast cancer and their cohabiting partners/spouses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- nationwide, population-based cohort of women diagnosed with breast cancer and their male cohabiting partner/spouse
Key inclusion criteria (3 listed)
- For patients: being a female patient diagnosed with primary breast cancer within the last four months
- For patients: cohabiting with a male partner/spouse
- For partners: being the male cohabiting partner/spouse of a patient diagnosed with primary breast cancer within the last four months
Key exclusion criteria (1 listed)
- For patients: previous diagnosis of breast cancer or breast cancer relapse
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 |
|---|---|---|
| questionnaireBoth the patient and the partner/spouse fill out a questionnaire that assesses their psychosocial adjustment. Time for completion is ca. 30 minutes. The questionnaire is administered at baseline and 5- and 12-months follow up. | Behavioural | Breast cancer patients and their partners |
Primary outcome
quality of life
Time frame: baseline
self-report questionnaire SF-36
quality of life
Time frame: 5-months follow up
self-report questionnaire SF-36
quality of life
Time frame: 12-months follow up
self-report questionnaire SF-36
depressive symptoms
Time frame: baseline
self-report questionnaire CES-D
depressive symptoms
Time frame: 5-months follow up
self-report questionnaire CES-D
depressive symptoms
Time frame: 12-months follow up
self-report questionnaire CES-D
dyadic coping
Time frame: baseline
self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire
dyadic coping
Time frame: 5-months follow up
self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire
dyadic coping
Time frame: 12-months follow up
self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire
22 secondary outcomes
illness perceptions
Time frame: baseline
use of antidepressants
Time frame: 12-months follow up
work ability
Time frame: baseline
work ability
Time frame: 5-months follow up
work ability
Time frame: 12-months follow up
sexual functioning
Time frame: baseline
sexual functioning
Time frame: 5-months follow up
sexual functioning
Time frame: 12-months follow up
body image
Time frame: baseline
body image
Time frame: 5-months follow up
body image
Time frame: 12-months follow up
relationship functioning
Time frame: baseline
relationship functioning
Time frame: 5-months follow up
relationship functioning
Time frame: 12-months follow up
symptom experience
Time frame: baseline
symptom experience
Time frame: 5-months follow up
symptom experience
Time frame: 12-months follow up
partner's involvement in breast cancer
Time frame: baseline
partner's involvement in breast cancer
Time frame: 5-months follow up
partner's involvement in breast cancer
Time frame: 12-months follow up
dimensions of sleep
Time frame: 5-months follow up
dimensions of sleep
Time frame: 12-months follow up
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 23 Apr 2014.
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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.
Dorte Gilså Hansen, MD, PhD study chair
Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
Christoffer Johansen, MD, PhD, DMSc study chair
Institute of Cancer Epidemiology, Danish Cancer Society
Mariet Hagedoorn, MSc, PhD study chair
University Medical Center Groningen
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 University of Southern Denmark at 1 site in Denmark.
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 3 inclusion and 1 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 23 Apr 2014. 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 Denmark. 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?
quality of life (time frame: baseline). The study lists 9 primary outcomes in all. 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 23 Apr 2014.