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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Odense University Hospital
Ringsted Hospital
University of Copenhagen
Region Southern Denmark
Danish Cancer Society
Information provided by (Responsible Party):
Anne Nicolaisen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01368380
First received: May 23, 2011
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care


Condition Intervention
Breast Cancer
Behavioral: Psychological intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Change in Impact of Event Scale (IES) [ Time Frame: Baseline, 2 weeks post-intervention, 10 months follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assesses mood changes. Assessed by both patients and partners


Secondary Outcome Measures:
  • Change in Dyadic Adjustment Scale - Revised (DAS-R) [ Time Frame: Baseline, 2 weeks post-intervention, 10 months follow-up ] [ Designated as safety issue: No ]
    Assesses relationship functioning and marital satisfaction. Assesed by both patients and partners

  • Change in Relationship Questionnaire (RQ) [ Time Frame: Baseline, 2 weeks post-intervention, 10 months follow-up ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 2 weeks post-intervention and 10 months follow-up ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 2 weeks post-intervention and 10 months follow-up ] [ Designated as safety issue: No ]
    Assesses health-related quality of life. Assessed by partners

  • Change in Functional Assessment of Chronic Illness Therapy-Fatigue [ Time Frame: Baseline, 2 weeks post-intervention and 10 months follow-up ] [ Designated as safety issue: No ]
    Assesses individual fellings of fatigue. Assessed by the patients

  • Change in Post Traumatic Growth Inventory [ Time Frame: 2-weeks post-intervention and 10 months follow-up ] [ Designated as safety issue: No ]
    Assesses positive changes in individuals experiencing traumatic life events. Assessed by both patients and partners

  • Change in EuroQol-5 Dimensions (EQ-5D) [ Time Frame: Baseline, 2 weeks post-intervention and 10 months follow-up ] [ Designated as safety issue: No ]
    Assesses health-related quality of life. Assessed by both patients and partners


Estimated Enrollment: 220
Study Start Date: October 2011
Estimated Study Completion Date: May 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychological Intervention Behavioral: Psychological intervention
Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.
No Intervention: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368380

Locations
Denmark
Herlev University Hospital
Herlev, Denmark, 2730
Odense University Hospital
Odense, Denmark, 5000
Ringsted Hospital
Ringsted, Denmark, 4100
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Ringsted Hospital
University of Copenhagen
Region Southern Denmark
Danish Cancer Society
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
  More Information

No publications provided

Responsible Party: Anne Nicolaisen, MPH, Ph.D. student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01368380     History of Changes
Other Study ID Numbers: NFK-SDU-2011-5
Study First Received: May 23, 2011
Last Updated: April 21, 2014
Health Authority: Denmark: The Ministry of the Interiour and Health

Keywords provided by University of Southern Denmark:
Breast cancer
Partners
Couples
Attachment
Intervention

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 20, 2014