- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01368380
Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners (HIH)
Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Herlev, Denmark, 2730
- Herlev University Hospital
-
Odense, Denmark, 5000
- Odense University Hospital
-
Ringsted, Denmark, 4100
- Ringsted Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
|
|
Experimental: Psychological Intervention
|
Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 2 weeks post-intervention, 10 months follow-up
|
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.
|
Baseline, 2 weeks post-intervention, 10 months follow-up
|
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
|
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)
Time Frame: Baseline, 2 weeks post-intervention, 10 months follow-up
|
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)
Time Frame: 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
|
Baseline, 2 weeks post-intervention, 10 months follow-up
|
Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time Frame: 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.
|
Baseline, 2 weeks post-intervention and 10 months follow-up
|
Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)
Time Frame: Baseline, 2 weeks post-intervention and 10 months follow-up
|
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
Time Frame: Baseline, 2 weeks post-intervention and 10 months follow-up
|
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
Time Frame: 2-weeks post-intervention and 10 months follow-up
|
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)
Time Frame: Baseline, 2 weeks post-intervention and 10 months follow-up
|
Assesses health-related quality of life.
Assessed by both patients and partners
|
Baseline, 2 weeks post-intervention and 10 months follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dorte G Hansen, PhD, University of Southern Denmark
- Study Chair: Mariët Hagedoorn, Professor, University of Groningen
- Study Chair: Christoffer Johansen, Professor, Danish Cancer Society
- Study Chair: Henrik Flyger, MD, Ph. D, University of Copenhagen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NFK-SDU-2011-5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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