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| ID | Type | Description | Link |
|---|---|---|---|
| R40-A1920 | Other Grant/Funding Number | Danish Cancer Society | |
| 2010-41-5193 | Other Identifier | Danish Data Protection Agency | |
| 2012-41-0901 | Other Identifier | new ID from the Danish Data Protection Agency |
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| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
| University of Groningen | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Herlev Hospital |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer patients and their partners | Patients with breast cancer and their cohabiting partners/spouses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | self-report questionnaire SF-36 | baseline |
| quality of life | self-report questionnaire SF-36 | 5-months follow up |
| quality of life | self-report questionnaire SF-36 | 12-months follow up |
| depressive symptoms | self-report questionnaire CES-D | baseline |
| depressive symptoms | self-report questionnaire CES-D | 5-months follow up |
| depressive symptoms | self-report questionnaire CES-D | 12-months follow up |
| dyadic coping | self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire | baseline |
| dyadic coping | self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire | 5-months follow up |
| dyadic coping |
| Measure | Description | Time Frame |
|---|---|---|
| illness perceptions | self-report questionnaire Brief-Illness Perception Questionnaire | baseline |
| use of antidepressants | registry information |
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Inclusion Criteria:
Exclusion Criteria:
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nationwide, population-based cohort of women diagnosed with breast cancer and their male cohabiting partner/spouse
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| Name | Affiliation | Role |
|---|---|---|
| Dorte Gilså Hansen, MD, PhD | Research Unit of General Practice, Institute of Public Health, University of Southern Denmark | Study Chair |
| Christoffer Johansen, MD, PhD, DMSc | Institute of Cancer Epidemiology, Danish Cancer Society | Study Chair |
| Mariet Hagedoorn, MSc, PhD | University Medical Center Groningen | Study Chair |
| Nina Rottmann, MSc | Research Unit of General Practice, Institute of Public Health, University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern Denmark | Odense | Southern Denmark | 5000 | Denmark |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| OTHER |
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self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire
| 12-months follow up |
| 12-months follow up |
| work ability | self-report item | baseline |
| work ability | self-report item | 5-months follow up |
| work ability | self-report item | 12-months follow up |
| sexual functioning | self-report items (PROMIS item bank) | baseline |
| sexual functioning | self-report items (PROMIS item bank) | 5-months follow up |
| sexual functioning | self-report items (PROMIS item bank) | 12-months follow up |
| body image | self-report questionnaire Body Image Scale | baseline |
| body image | self-report questionnaire Body Image Scale | 5-months follow up |
| body image | self-report questionnaire Body Image Scale | 12-months follow up |
| relationship functioning | self-report items; quality of relationship and intimacy | baseline |
| relationship functioning | self-report items; quality of relationship and intimacy | 5-months follow up |
| relationship functioning | self-report items; quality of relationship and intimacy | 12-months follow up |
| symptom experience | self-report questionnaire BCPT Eight Symptom Scale | baseline |
| symptom experience | self-report questionnaire BCPT Eight Symptom Scale | 5-months follow up |
| symptom experience | self-report questionnaire BCPT Eight Symptom Scale | 12-months follow up |
| partner's involvement in breast cancer | self-report questionnaire | baseline |
| partner's involvement in breast cancer | self-report questionnaire | 5-months follow up |
| partner's involvement in breast cancer | self-report questionnaire | 12-months follow up |
| dimensions of sleep | self-report questionnaire MOS sleep measure | 5-months follow up |
| dimensions of sleep | self-report questionnaire MOS sleep measure | 12-months follow up |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |