Effects of an Integrative Day-care Clinic Program for Breast Cancer Patients During Chemotherapy

NCT ID: NCT03868865

Last Updated: 2019-03-11

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

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-07

Study Completion Date

2015-04-07

Brief Summary

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The aim of the study was to evaluate a new integrative day-care clinic concept for breast cancer patients receiving chemotherapy. This is an explorative pilot study. Therefore, all outcomes are analyzed exploratively.

Detailed Description

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Conditions

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Breast Cancer Chemotherapy Mind-Body-Medicine Acupuncture Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Integrative mind-body-medicine group program

The 66 hour program encompasses mindfulness training, yoga, moderate exercise, nutrition, naturopathic self-help strategies, cognitive restructuring and acupuncture for the management of side effects caused by chemotherapy.

Group Type EXPERIMENTAL

Integrative mind-body-medicine group program

Intervention Type BEHAVIORAL

The mind-body-medicine group program focuses on support in coping with the disease, in lifestyle modification and in reduction of chemotherapy induced side effects. The self-contained modules of the mind-body-medicine group program can be followed in an individual order, to allow adoption to different chemotherapy concepts and continued access is possible. Patients can join in the group program eleven times for six hours each visit. They participate in every one of the eleven modules once.

Interventions

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Integrative mind-body-medicine group program

The mind-body-medicine group program focuses on support in coping with the disease, in lifestyle modification and in reduction of chemotherapy induced side effects. The self-contained modules of the mind-body-medicine group program can be followed in an individual order, to allow adoption to different chemotherapy concepts and continued access is possible. Patients can join in the group program eleven times for six hours each visit. They participate in every one of the eleven modules once.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* curative malignancy (breast cancer of TNM (T: primary tumor, N: regional nodes, M: metastasis) staging I-III)
* receiving chemotherapy
* at least 18 years old
* written informed consent
* willing and physically/mentally able to participate in a six hours day care clinic program eleven times during chemotherapy.

Exclusion Criteria

* insufficient knowledge of the German language
* physical or mental disabilities resulting in ineligibility for participation in the program or filling out the questionnaires.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Petra Voiss

Study physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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17-7909-BO

Identifier Type: -

Identifier Source: org_study_id

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