Psychotherapy to Patients With Primary Breast Cancer - Psycho-social and Survival Outcome From a Randomised Trial

This study has been completed.
Sponsor:
Information provided by:
Danish Cancer Society
ClinicalTrials.gov Identifier:
NCT01108224
First received: February 16, 2010
Last updated: April 20, 2010
Last verified: January 2004
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Psychosocial support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Psychosocial Group Intervention to Patients With Primary Breast Cancer - Psychosocial and Survival Outcome From a Randomised Study

Resource links provided by NLM:


Further study details as provided by Danish Cancer Society:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 12 months post intervention ] [ Designated as safety issue: No ]
    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?


Secondary Outcome Measures:
  • Survival [ Time Frame: 5 years post surgery ] [ Designated as safety issue: No ]
    Does primary breast cancer patients who participate in a psychosocial intervention survive for longer time compared to a control group of primary cancer patients who do not participate in any intervention?


Enrollment: 210
Study Start Date: January 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychosocial support Behavioral: Psychosocial support
Psycho-social group intervention including patient-education for 6 h per week for 2 weeks and group therapy 2½ h for 8 weeks
Other Name: Patient-education and group therapy
No Intervention: Control group

Detailed Description:

PURPOSE: This randomized study included patients diagnosed with breast cancer who participated in an intervention including education and group psychotherapy lasting 10 weeks after surgery. The purpose of the study was to enhance Quality of Life, coping and social relations and to support the women when going through treatment. PATIENTS AND METHODS: We randomly assigned 210 patients with primary breast cancer to a control or an intervention group. Patients in the intervention group were offered 2 weekly 6-hour sessions of psycho-education and eight weekly 2-hour sessions of group psychotherapy. Participants and nonparticipants were followed up for QoL, coping and social relations after one, six and twelve months post intervention and on vital status 5 years after surgical treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Distant metastasis
  • Not speaking or understanding Danish
  • Over 71 years
  • Other life-threatening diseases
  • Brain-damaged
  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: NCT01108224

Sponsors and Collaborators
Danish Cancer Society
Investigators
Principal Investigator: Ellen H Boesen, MSc, Phd Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100
Study Chair: Christoffer Johansen, DSc (Med) Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100
  More Information

No publications provided

Responsible Party: Ellen H. Boesen, MSc, PhD, Danish Cancer Society
ClinicalTrials.gov Identifier: NCT01108224     History of Changes
Other Study ID Numbers: Camma 2003
Study First Received: February 16, 2010
Last Updated: April 20, 2010
Health Authority: Denmark: Ethics Committee

Keywords provided by Danish Cancer Society:
Quality of life
Coping
Social relations
Survival
Psychotherapy

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

ClinicalTrials.gov processed this record on July 24, 2014