NCT01108224

Brief Summary

The purpose of this study is to determine whether an intervention to breast cancer patients including psycho-education and group psychotherapy can enhance quality of life and survival.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable breast-cancer

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

Study Start

First participant enrolled

January 1, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
Last Updated

April 21, 2010

Status Verified

January 1, 2004

Enrollment Period

2.9 years

First QC Date

February 16, 2010

Last Update Submit

April 20, 2010

Conditions

Breast Cancer

Keywords

Quality of lifeCopingSocial relationsSurvivalPsychotherapy

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Does Quality of Life enhance among a group of primary breast cancer patients who participate in a psychosocial group intervention compared to a control group of primary breast cancer patients who do not recieve any psychosocial intervention?

    12 months post intervention

Secondary Outcomes (1)

  • Survival

    5 years post surgery

Study Arms (2)

Psychosocial support

EXPERIMENTAL
Behavioral: Psychosocial support

Control group

NO INTERVENTION

Interventions

Psychosocial supportBEHAVIORAL

Psycho-social group intervention including patient-education for 6 h per week for 2 weeks and group therapy 2½ h for 8 weeks

Also known as: Patient-education and group therapy
Psychosocial support

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible patients were 18-70 years of age with stage I-IIIA primary breast cancer

You may not qualify if:

  • Distant metastasis
  • Not speaking or understanding Danish
  • Over 71 years
  • Other life-threatening diseases
  • Brain-damaged

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Psychiatric RehabilitationPatient Education as TopicPsychotherapy, Group

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesHealth EducationPreventive Health ServicesSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ellen H Boesen, MSc, Phd

    Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100

    PRINCIPAL INVESTIGATOR

  • Christoffer Johansen, DSc (Med)

    Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2010

First Posted

April 21, 2010

Study Start

January 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

April 21, 2010

Record last verified: 2004-01