Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Psychological intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological Intervention<br> | Behavioral: Psychological intervention<br>* Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.<br>|
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Partners, Couples, Attachment, Intervention