Breast Cancer
Conditions
Keywords
Breast cancer, Partners, Couples, Attachment, Intervention
Brief summary
This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care
Detailed description
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.
Interventions
BEHAVIORALPsychological intervention
Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.
Sponsors
Odense University Hospital
Ringsted Hospital
University of Copenhagen
Region of Southern Denmark
Danish Cancer Society
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women newly diagnosed with a primary breast cancer (in the last 4 weeks) * Women cohabiting with a male partner in a romantic relationship * Patient and partner speaks and reads danish
Exclusion criteria
* Patients having a previous cancer diagnosis * Neoadjuvant therapy for breast cancer * Previous hospital admission with diagnosed psychotic episodes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Impact of Event Scale (IES) | Baseline, 2 weeks post-intervention, 10 months follow-up | IES assesses traumatic reactions to the breast cancer diagnosis. Assessed by both patients and partners |
| Change in The Hospital Anxiety and Depression Scale (HADS) | Baseline, 2 weeks post-intervention, 10 months follow-up | Assesses feelings of anxiety and depressive symptoms. Assessed by both patients and partners. |
| Change in The Profile of Mood States - Short Form (POMS-SF) | Baseline, 2 weeks post-intervention, 10 months follow-up | Assesses mood changes. Assessed by both patients and partners |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Assessment of Cancer Therapy - general population (FACT-GP) | Baseline, 2 weeks post-intervention and 10 months follow-up | Assesses health-related quality of life. Assessed by partners |
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue | Baseline, 2 weeks post-intervention and 10 months follow-up | Assesses individual fellings of fatigue. Assessed by the patients |
| Change in Dyadic Adjustment Scale - Revised (DAS-R) | Baseline, 2 weeks post-intervention, 10 months follow-up | Assesses relationship functioning and marital satisfaction. Assesed by both patients and partners |
| Change in EuroQol-5 Dimensions (EQ-5D) | Baseline, 2 weeks post-intervention and 10 months follow-up | Assesses health-related quality of life. Assessed by both patients and partners |
| Change in Post Traumatic Growth Inventory | 2-weeks post-intervention and 10 months follow-up | Assesses positive changes in individuals experiencing traumatic life events. Assessed by both patients and partners |
| Change in Relationship Questionnaire (RQ) | Baseline, 2 weeks post-intervention, 10 months follow-up | RQ provides a profile of an individual's attachment feelings and behaviour. Assessed by both patients and partners |
| Change in Functional Assessment of Cancer Therapy - Breast (FACT-B) | Baseline, 2 weeks post-intervention and 10 months follow-up | Assesses health-related quality of life with additional questions for women dignosed with breast cancer. |
Countries
Denmark
Outcome results
None listed