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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychosocial support
Sponsored by
Danish Cancer Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Quality of life, Coping, Social relations, Survival, Psychotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Psychosocial support

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    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?

    Secondary Outcome Measures

    Survival
    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?

    Full Information

    First Posted
    February 16, 2010
    Last Updated
    April 20, 2010
    Sponsor
    Danish Cancer Society
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01108224
    Brief Title
    Psychotherapy to Patients With Primary Breast Cancer - Psycho-social and Survival Outcome From a Randomised Trial
    Official Title
    Psychosocial Group Intervention to Patients With Primary Breast Cancer - Psychosocial and Survival Outcome From a Randomised Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Danish Cancer Society

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Quality of life, Coping, Social relations, Survival, Psychotherapy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    210 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Psychosocial support
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychosocial support
    Other Intervention Name(s)
    Patient-education and group therapy
    Intervention Description
    Psycho-social group intervention including patient-education for 6 h per week for 2 weeks and group therapy 2½ h for 8 weeks
    Primary Outcome Measure Information:
    Title
    Quality of life
    Description
    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?
    Time Frame
    12 months post intervention
    Secondary Outcome Measure Information:
    Title
    Survival
    Description
    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?
    Time Frame
    5 years post surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ellen H Boesen, MSc, Phd
    Organizational Affiliation
    Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Christoffer Johansen, DSc (Med)
    Organizational Affiliation
    Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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