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

Not Applicable

Completed

• Conditions: Chemotherapy; Quality of Life; Breast Cancer; Mind-Body-Medicine; Acupuncture
• Interventions: Behavioral: Integrative mind-body-medicine group program

• Registration Number: NCT03868865
• Lead Sponsor: Universität Duisburg-Essen

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-08-07
• Primary Completion: 2015-04-07
• Study Completion: 2015-04-07
• Study First Submitted: 2019-02-27
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-06
• Last Update Submitted: 2019-03-06
• Study First Posted: 2019-03-11
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Integrative mind-body-medicine group program	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.

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)	up to 26 weeks (depending on chemotherapy regime)	It measures the 2 dimensions anxiety and depression. Scores range from 0 to 21 with higher values indicate higher distress. Values of \>8 indicate potential subclinical anxiety or depressive disorders
Brief Fatigue Inventory (BFI)	up to 26 weeks (depending on chemotherapy regime)	BFI has been validated as a short and comprehensive instrument to assess severity of fatigue (three questions) and fatigue-related impairment (six questions) in cancer patients with a 9-item, 11-point rating scale. Higher scores on the BFI correspond to greater severity of fatigue / impairment through fatigue over the past 24 hours.
Satisfaction with the program	up to 26 weeks (depending on chemotherapy regime)	Satisfaction was assessed at T1 by 5 questions regarding fulfilled expectations about the program contents, relevance for coping with cancer, social support of the group setting, transferring into everyday life, and recommendation of the program. Each question could be scored from 1=totally agree to 6=totally disagree.
European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ-C30)	up to 26 weeks (depending on chemotherapy regime)	Besides the global quality of life subscale, this instrument assesses five functional domains of quality of life: physical, role, emotional, cognitive, and social function. Symptom scales further assess fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties. Scores of all subscales range from 0 to 100, while a higher score represents a better level of functioning or a worse amount of symptoms.
Patients and numbers of adverse events	up to 26 weeks (depending on chemotherapy regime)	All adverse events that occurred during the study period were recorded by the study physician during each day care clinic visit, regardless of their potential relation to the study intervention. After the intervention, patients were also asked to report adverse events not previously mentioned.
Perceived Stress Scale (PSS)	up to 26 weeks (depending on chemotherapy regime)	Perceived stress was assessed by the 10-item version of the PSS, rated for the past month on a 5-point rating scale. For the summed items (range from 0 to 40) a higher total score indicates greater stress.

Trial Locations

Locations (1)

Kliniken Essen-Mitte; 🇩🇪 Essen, NRW, Germany