University of Southern Denmark
Odense, Southern Denmark, 5000, Denmark
NCT Number: NCT01392066
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.
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Notify Me18 year and older
All sexes
Observational
Odense, Southern Denmark, 5000, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline
self-report questionnaire SF-36
Time frame: 5-months follow up
self-report questionnaire SF-36
Time frame: 12-months follow up
self-report questionnaire SF-36
Time frame: baseline
self-report questionnaire CES-D
Time frame: 5-months follow up
self-report questionnaire CES-D
Time frame: 12-months follow up
self-report questionnaire CES-D
Time frame: baseline
self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire
Time frame: 5-months follow up
self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire
Time frame: 12-months follow up
self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire
Time frame: baseline
self-report questionnaire Brief-Illness Perception Questionnaire
Time frame: 12-months follow up
registry information
Time frame: baseline
self-report item
Time frame: 5-months follow up
self-report item
Time frame: 12-months follow up
self-report item
Time frame: baseline
self-report items (PROMIS item bank)
Time frame: 5-months follow up
self-report items (PROMIS item bank)
Time frame: 12-months follow up
self-report items (PROMIS item bank)
Time frame: baseline
self-report questionnaire Body Image Scale
Time frame: 5-months follow up
self-report questionnaire Body Image Scale
Time frame: 12-months follow up
self-report questionnaire Body Image Scale
Time frame: baseline
self-report items; quality of relationship and intimacy
Time frame: 5-months follow up
self-report items; quality of relationship and intimacy
Time frame: 12-months follow up
self-report items; quality of relationship and intimacy
Time frame: baseline
self-report questionnaire BCPT Eight Symptom Scale
Time frame: 5-months follow up
self-report questionnaire BCPT Eight Symptom Scale
Time frame: 12-months follow up
self-report questionnaire BCPT Eight Symptom Scale
Time frame: baseline
self-report questionnaire
Time frame: 5-months follow up
self-report questionnaire
Time frame: 12-months follow up
self-report questionnaire
Time frame: 5-months follow up
self-report questionnaire MOS sleep measure
Time frame: 12-months follow up
self-report questionnaire MOS sleep measure
University of Southern Denmark
Other
Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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