Breast CancerNCT03868865
Effects of an Integrative Day-care Clinic Program for Breast Cancer Patients During Chemotherapy
A study testing Integrative mind-body-medicine group program in people with Breast Cancer and Chemotherapy, run by Universität Duisburg-Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy, Mind-Body-Medicine
- What is being tested?
- Integrative mind-body-medicine group program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- 7 Aug 2012to 7 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- insufficient knowledge of the German language
- physical or mental disabilities resulting in ineligibility for participation in the program or filling out the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Integrative Day-care Clinic Program for Breast Cancer Patients During Chemotherapy: an Observational Study
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
- Being tested
- Integrative mind-body-medicine group program
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative mind-body-medicine group programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Integrative mind-body-medicine group program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 26 weeks (depending on chemotherapy regime)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start7 Aug 2012
- Primary completion7 Apr 2015
- Study completion7 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Petra Voiss, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868865
- Sponsor's protocol ID
- 17-7909-BO
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Integrative Day-care Clinic Program for Breast Cancer Patients During Chemotherapy: an Observational Study
- ClinicalTrials.gov ID
- NCT03868865
- Acronym / sponsor ID
- 17-7909-BO
- Conditions
- Breast Cancer, Chemotherapy, Mind-Body-Medicine, Acupuncture, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 7 Aug 2012 (actual)
- Primary completion
- 7 Apr 2015 (actual)
- Study completion
- 7 Apr 2015 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrative mind-body-medicine group program | Experimental | Behavioral: Integrative mind-body-medicine group programThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- insufficient knowledge of the German language
- physical or mental disabilities resulting in ineligibility for participation in the program or filling out the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative mind-body-medicine group programThe 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. | Behavioural | Integrative mind-body-medicine group program |
Primary outcome
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.
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
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative mind-body-medicine group program in people with Breast Cancer and Chemotherapy, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ-C30) (time frame: up to 26 weeks (depending on chemotherapy regime)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.