Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: For patients: previous diagnosis of breast cancer or breast cancer relapse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer patients and their partners<br>Patients with breast cancer and their cohabiting partners/spouses | Behavioral: questionnaire<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire | 12-months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| illness perceptions | self-report questionnaire Brief-Illness Perception Questionnaire | baseline | 
| use of antidepressants | registry information | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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couples, breast neoplasms, spouses/partners, interpersonal relations, psychosocial adjustment, psychological adaptation, depression, quality of life, dyadic coping, coping behavior, cohort, questionnaire