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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868865
• Other study ID #: 17-7909-BO
• Status: Completed
• Phase: N/A
• Start date: August 7, 2012
• Est. completion date: April 7, 2015

Study information

• Verified date: March 2019
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 7, 2015
• Est. primary completion date: April 7, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Germany	Kliniken Essen-Mitte	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ-C30)	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.	up to 26 weeks (depending on chemotherapy regime)
Primary	Hospital Anxiety and Depression Scale (HADS)	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	up to 26 weeks (depending on chemotherapy regime)
Primary	Brief Fatigue Inventory (BFI)	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.	up to 26 weeks (depending on chemotherapy regime)
Primary	Perceived Stress Scale (PSS)	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.	up to 26 weeks (depending on chemotherapy regime)
Primary	Satisfaction with the program	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.	up to 26 weeks (depending on chemotherapy regime)
Primary	Patients and numbers of adverse events	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.	up to 26 weeks (depending on chemotherapy regime)