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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

February 16, 2010
April 20, 2010
January 2004
December 2006   (final data collection date for primary outcome measure)
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?
Same as current
Complete list of historical versions of study NCT01108224 on ClinicalTrials.gov Archive Site
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?
Same as current
Not Provided
Not Provided
 
Psychotherapy to Patients With Primary Breast Cancer - Psycho-social and Survival Outcome From a Randomised Trial
Psychosocial Group Intervention to Patients With Primary Breast Cancer - Psychosocial and Survival Outcome From a Randomised Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
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
  • Experimental: Psychosocial support
    Intervention: Behavioral: Psychosocial support
  • No Intervention: Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01108224
Camma 2003
No
Ellen H. Boesen, MSc, PhD, Danish Cancer Society
Danish Cancer Society
Not Provided
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
Danish Cancer Society
January 2004

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