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Completed

NCT Number: NCT01108224

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychosocial support

Behavioral

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

Other names: Patient-education and group therapy

Primary outcomes

  1. Quality of life

    Time frame: 12 months post intervention

    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 outcomes

  1. Survival

    Time frame: 5 years post surgery

    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?

Sponsors and collaborators

Lead sponsor

Danish Cancer Society

Other

Registry information

Official study title

Psychosocial Group Intervention to Patients With Primary Breast Cancer - Psychosocial and Survival Outcome From a Randomised Study

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Apr 21, 2010
Registry last updated
Apr 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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