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Completed

NCT Number: NCT03868865

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

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.

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Key information

Conditions

Breast Cancer Acupuncture Breast Diseases Breast Neoplasms Chemotherapy Mind-Body-Medicine Neoplasms Neoplasms by Site Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45136, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ-C30)

    Time frame: 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.

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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

  3. Brief Fatigue Inventory (BFI)

    Time frame: 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.

  4. Perceived Stress Scale (PSS)

    Time frame: 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.

  5. Satisfaction with the program

    Time frame: 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.

  6. Patients and numbers of adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 11, 2019
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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