Viewing Study NCT01108224



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Last Modification Date: 2024-10-26 @ 10:18 AM
Study NCT ID: NCT01108224
Status: COMPLETED
Last Update Posted: 2010-04-21
First Post: 2010-02-16

Brief Title: Psychotherapy to Patients With Primary Breast Cancer - Psycho-social and Survival Outcome From a Randomised Trial
Sponsor: Danish Cancer Society
Organization: Danish Cancer Society

Study Overview

Official Title: Psychosocial Group Intervention to Patients With Primary Breast Cancer - Psychosocial and Survival Outcome From a Randomised Study
Status: COMPLETED
Status Verified Date: 2004-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None