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

NCT03868865 | Completed

• 1 other identifier: 17-7909-BO
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Integrative mind-body-medicine group program

EXPERIMENTAL

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.

Behavioral: Integrative mind-body-medicine group program

Interventions

Integrative mind-body-medicine group program 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.

Integrative mind-body-medicine group program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45136, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study physician

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 11, 2019
• Study Start: August 7, 2012
• Primary Completion: April 7, 2015
• Study Completion: April 7, 2015
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

DE (1)