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

NCT ID: NCT01108224

Last Updated: 2010-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Psychosocial support

Group Type EXPERIMENTAL

Psychosocial support

Intervention Type BEHAVIORAL

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

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Patient-education and group therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role lead

Responsible Party

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Danish Cancer Society

Principal Investigators

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Ellen H Boesen, MSc, Phd

Role: PRINCIPAL_INVESTIGATOR

Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100

Christoffer Johansen, DSc (Med)

Role: STUDY_CHAIR

Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100

Other Identifiers

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Camma 2003

Identifier Type: -

Identifier Source: org_study_id

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