Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Psychological intervention
- Registration Number
- NCT01368380
- Lead Sponsor
- University of Southern Denmark
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 198
- 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
- Patients having a previous cancer diagnosis
- Neoadjuvant therapy for breast cancer
- Previous hospital admission with diagnosed psychotic episodes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psychological Intervention Psychological intervention -
- Primary Outcome Measures
Name Time Method 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
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.
- Secondary Outcome Measures
Name Time Method 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 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.
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 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 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
Trial Locations
- Locations (3)
Herlev University Hospital
🇩🇰Herlev, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Ringsted Hospital
🇩🇰Ringsted, Denmark