Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of Southern Denmark
- Enrollment
- 198
- Locations
- 3
- Primary Endpoint
- Change in Impact of Event Scale (IES)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Anne Nicolaisen
MPH, Ph.D. student
University of Southern Denmark
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Impact of Event Scale (IES)
Time Frame: 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)
Time Frame: 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)
Time Frame: Baseline, 2 weeks post-intervention, 10 months follow-up
Assesses mood changes. Assessed by both patients and partners
Secondary Outcomes
- Change in Dyadic Adjustment Scale - Revised (DAS-R)(Baseline, 2 weeks post-intervention, 10 months follow-up)
- Change in Relationship Questionnaire (RQ)(Baseline, 2 weeks post-intervention, 10 months follow-up)
- Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)(Baseline, 2 weeks post-intervention and 10 months follow-up)
- Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)(Baseline, 2 weeks post-intervention and 10 months follow-up)
- Change in Functional Assessment of Chronic Illness Therapy-Fatigue(Baseline, 2 weeks post-intervention and 10 months follow-up)
- Change in Post Traumatic Growth Inventory(2-weeks post-intervention and 10 months follow-up)
- Change in EuroQol-5 Dimensions (EQ-5D)(Baseline, 2 weeks post-intervention and 10 months follow-up)