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

Breast Cancer Clinical Trial

— HIH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368380
• Other study ID #: NFK-SDU-2011-5
• Status: Completed
• Phase: N/A
• First received: May 23, 2011
• Last updated: February 25, 2015
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Ministry of the Interiour and Health
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: May 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Psychological intervention
Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.

Locations

Country	Name	City	State
Denmark	Herlev University Hospital	Herlev
Denmark	Odense University Hospital	Odense
Denmark	Ringsted Hospital	Ringsted

Sponsors (6)

Lead Sponsor	Collaborator
University of Southern Denmark	Danish Cancer Society, Odense University Hospital, Region of Southern Denmark, Ringsted Hospital, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No