NCT01368380

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

1.8 years

First QC Date

May 23, 2011

Last Update Submit

February 25, 2015

Conditions

Breast Cancer

Keywords

Breast cancerPartnersCouplesAttachmentIntervention

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • Change in Dyadic Adjustment Scale - Revised (DAS-R)

    Baseline, 2 weeks post-intervention, 10 months follow-up

  • Change in Relationship Questionnaire (RQ)

    Baseline, 2 weeks post-intervention, 10 months follow-up

  • Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)

    Baseline, 2 weeks post-intervention and 10 months follow-up

  • Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)

    Baseline, 2 weeks post-intervention and 10 months follow-up

  • Change in Functional Assessment of Chronic Illness Therapy-Fatigue

    Baseline, 2 weeks post-intervention and 10 months follow-up

  • +2 more secondary outcomes

Study Arms (2)

Psychological Intervention

EXPERIMENTAL
Behavioral: Psychological intervention

Usual care

NO INTERVENTION

Interventions

Psychological interventionBEHAVIORAL

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

Psychological Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients having a previous cancer diagnosis
  • Neoadjuvant therapy for breast cancer
  • Previous hospital admission with diagnosed psychotic episodes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Herlev University Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Ringsted Hospital

Ringsted, 4100, Denmark

Location

Related Publications (1)

  • Nicolaisen A, Hansen DG, Hagedoorn M, Flyger HE, Rottmann N, Nielsen P, Soe K, Pedersen AE, Johansen C. Attachment-oriented psychological intervention for couples facing breast cancer: protocol of a randomised controlled trial. BMC Psychol. 2014 Jul 14;2(1):19. doi: 10.1186/2050-7283-2-19. eCollection 2014.

    PMID: 25815190DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dorte G Hansen, PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

  • Mariët Hagedoorn, Professor

    University of Groningen

    STUDY CHAIR

  • Christoffer Johansen, Professor

    Danish Cancer Society

    STUDY CHAIR

  • Henrik Flyger, MD, Ph. D

    University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MPH, Ph.D. student

Study Record Dates

First Submitted

May 23, 2011

First Posted

June 7, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2013

Study Completion

May 1, 2014

Last Updated

February 26, 2015

Record last verified: 2015-02

Locations

DK(3)