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

Universität Duisburg-Essen

Status: Completed

Conditions: Breast Cancer; Chemotherapy; Mind-Body-Medicine; Quality of Life; Acupuncture

Treatments: Behavioral: Integrative mind-body-medicine group program

Study type: Interventional

Funder types: Other

Identifiers

NCT03868865

17-7909-BO

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Integrative mind-body-medicine group program

Experimental group

Description:

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.

Treatment:

Behavioral: Integrative mind-body-medicine group program