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: November 17, 2013
Last verified: November 2013

May 23, 2011
November 17, 2013
October 2011
May 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01368380 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners
Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
Behavioral: Psychological intervention
Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.
  • Experimental: Psychological Intervention
    Intervention: Behavioral: Psychological intervention
  • No Intervention: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
220
May 2014
May 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01368380
NFK-SDU-2011-5
Yes
Anne Nicolaisen, University of Southern Denmark
University of Southern Denmark
  • Odense University Hospital
  • Ringsted Hospital
  • University of Copenhagen
  • Region Southern Denmark
  • Danish Cancer Society
Principal Investigator: Dorte Gilså 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
University of Southern Denmark
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP