Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Ringsted Hospital | UNKNOWN |
| University of Copenhagen | OTHER |
| Region of Southern Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care
The intervention intends to improving the patient and partners well-being, quality of life and their relationship adjustment.
The couples in the intervention group participates i six to eight couple sessions. The sessions is conducted by an experienced psychologist and takes place one to five months after the patients cancer diagnosis. The control group receives usual care.
The framework of the intervention is attachment theory and the psychologists support and advise the couples in talking candidly about their feelings regarding their new life situation with cancer. The psychologist focus on the couples ability to feel comfortable and safe in each others presence.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychological Intervention | Experimental |
| |
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological intervention | Behavioral | Couples in the intervention group attends six to eight couple-sessions performed by a psychologist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Impact of Event Scale (IES) | IES assesses traumatic reactions to the breast cancer diagnosis. Assessed by both patients and partners | Baseline, 2 weeks post-intervention, 10 months follow-up |
| Change in The Hospital Anxiety and Depression Scale (HADS) | Assesses feelings of anxiety and depressive symptoms. Assessed by both patients and partners. | Baseline, 2 weeks post-intervention, 10 months follow-up |
| Change in The Profile of Mood States - Short Form (POMS-SF) | Assesses mood changes. Assessed by both patients and partners | Baseline, 2 weeks post-intervention, 10 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dyadic Adjustment Scale - Revised (DAS-R) | Assesses relationship functioning and marital satisfaction. Assesed by both patients and partners | Baseline, 2 weeks post-intervention, 10 months follow-up |
| Change in Relationship Questionnaire (RQ) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dorte G Hansen, PhD | University of Southern Denmark | Principal Investigator |
| Mariët Hagedoorn, Professor | University of Groningen | Study Chair |
| Christoffer Johansen, Professor | Danish Cancer Society | Study Chair |
| Henrik Flyger, MD, Ph. D | University of Copenhagen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev University Hospital | Herlev | 2730 | Denmark | |||
| Odense University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25815190 | Derived | Nicolaisen A, Hansen DG, Hagedoorn M, Flyger HE, Rottmann N, Nielsen P, Soe K, Pedersen AE, Johansen C. Attachment-oriented psychological intervention for couples facing breast cancer: protocol of a randomised controlled trial. BMC Psychol. 2014 Jul 14;2(1):19. doi: 10.1186/2050-7283-2-19. eCollection 2014. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000083626 | Psychosocial Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
| OTHER |
| Danish Cancer Society | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
RQ provides a profile of an individual's attachment feelings and behaviour. Assessed by both patients and partners |
| Baseline, 2 weeks post-intervention, 10 months follow-up |
| Change in Functional Assessment of Cancer Therapy - Breast (FACT-B) | Assesses health-related quality of life with additional questions for women dignosed with breast cancer. | Baseline, 2 weeks post-intervention and 10 months follow-up |
| Change in Functional Assessment of Cancer Therapy - general population (FACT-GP) | Assesses health-related quality of life. Assessed by partners | Baseline, 2 weeks post-intervention and 10 months follow-up |
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue | Assesses individual fellings of fatigue. Assessed by the patients | Baseline, 2 weeks post-intervention and 10 months follow-up |
| Change in Post Traumatic Growth Inventory | Assesses positive changes in individuals experiencing traumatic life events. Assessed by both patients and partners | 2-weeks post-intervention and 10 months follow-up |
| Change in EuroQol-5 Dimensions (EQ-5D) | Assesses health-related quality of life. Assessed by both patients and partners | Baseline, 2 weeks post-intervention and 10 months follow-up |
| Odense |
| 5000 |
| Denmark |
| Ringsted Hospital | Ringsted | 4100 | Denmark |
| D017437 |
| Skin and Connective Tissue Diseases |