Breast CancerPhase 4BBKNCT01458457
Life Quality and Mental State in Patients With Breast Cancer
A Phase 4 study testing Individualized complementary medicine treatment in people with Breast Cancer, run by Charite University, Berlin, Germany at 1 site in Italy.
Trial summary
Randomized pragmatic trial to evaluate the comparative effectiveness regarding disease specific quality of life of an individualized additional complementary medicine treatment in addition to usual care with usual care only in 280 women with breast cancer Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Individualized complementary medicine treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteItaly
- Study dates
- May 2011to Jul 2013
- Phase
- Phase 4
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed breast cancer
- current usual care treatment
- willing to refrain from complementary treatment for 6 months in case of randomization into the usual care group
- informed consent
Who cannot join
- complementary treatment at the Hospital Meran in the last 6 months
- no German or Italian language ability
- participation in other study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Life Quality and Mental State in Patients With Breast Cancer - a Randomized Study
Randomized pragmatic trial to evaluate the comparative effectiveness regarding disease specific quality of life of an individualized additional complementary medicine treatment in addition to usual care with usual care only in 280 women with breast cancer
- Conditions
- Breast Cancer
- Being tested
- Individualized complementary medicine treatment, Individualized usual care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized complementary medicine treatmentOther
An individual treatment plan will be made for each patient that includes one to all of the following treatments: acupuncture, traditional Chinese herbal medicine, enzyme therapy, nutrition advise, Healing Touch, homoeopathy, hyperthermia treatment, infusions, laser therapy, lymphatic drainage, manual therapy, mistel therapy, neural therapy, orthomolecular therapy, osteopathy, phytotherapy, shiatsu
Individualized usual careOther
Patients get usual care from their general practitioners/specialized physicians
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Not described Receives: Other: Individualized usual care |
| Usual Care + Complementary Medicine | Active comparator | Not described Receives: Other: Individualized complementary medicine treatment; Other: Individualized usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Measured: 6 months
Secondary outcomes (13)
Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B)
Measured: 3 months
Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being)
Measured: 3, 6 months
Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Measured: 3, 6 months
Pain, quality of sleep, and nausea (single items of the FACT-B)
Measured: 3, 6 months
Functional Assessment of Chronic Illness Therapy-Fatigue
Measured: 3, 6 months
Survival without relapse
Measured: 6 months
Quality of Life (SF-12 Health Survey)
Measured: 3, 6 months
Undesirable Effects and Interactions
Measured: 6 months
Goal Attainment Scale
This outcome measures will only be assessed in the complementary medicine arm
Measured: 3 months
Used complementary Therapies and their frequency
This will only be assessed in the complementary medicine arm
Measured: 6 months
Expectations at Baseline
This will only be assessed in the complementary medicine group
Measured: Baseline
Satisfaction and patient-reported effectiveness
This will only be assessed in the complementary medicine arm
Measured: 3, 6 months
Survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Claudia M Witt, Prof. Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458457
- Sponsor's protocol ID
- BBK
- Acronym
- BBK
- Status last verified
- Feb 2015
- First submitted
- 21 Oct 2011
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Witt CM, Ausserer O, Baier S, Heidegger H, Icke K, Mayr O, Mitterer M, Roll S, Spizzo G, Scherer A, Thuile C, Wieser A, Schutzler L. Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial. Breast Cancer Res Treat. 2015 Jan;149(2):449-60. doi: 10.1007/s10549-014-3249-3. Epub 2015 Jan 3.
PubMed 25555830
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Quality and Mental State in Patients With Breast Cancer - a Randomized Study
- ClinicalTrials.gov ID
- NCT01458457
- Acronym / sponsor ID
- BBK / BBK
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Oct 2011 (estimated)
- 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.
Randomized pragmatic trial to evaluate the comparative effectiveness regarding disease specific quality of life of an individualized additional complementary medicine treatment in addition to usual care with usual care only in 280 women with breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Individualized usual care |
| Usual Care + Complementary Medicine | Active comparator | Other: Individualized complementary medicine treatment, Other: Individualized usual care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed breast cancer
- current usual care treatment
- willing to refrain from complementary treatment for 6 months in case of randomization into the usual care group
- informed consent
Key exclusion criteria (3 listed)
- complementary treatment at the Hospital Meran in the last 6 months
- no German or Italian language ability
- participation in other study
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 |
|---|---|---|
| Individualized complementary medicine treatmentAn individual treatment plan will be made for each patient that includes one to all of the following treatments: acupuncture, traditional Chinese herbal medicine, enzyme therapy, nutrition advise, Healing Touch, homoeopathy, hyperthermia treatment, infusions, laser therapy, lymphatic drainage, manual therapy, mistel therapy, neural therapy, orthomolecular therapy, osteopathy, phytotherapy, shiatsu | Other | Usual Care + Complementary Medicine |
| Individualized usual carePatients get usual care from their general practitioners/specialized physicians | Other | Usual Care + Complementary Medicine, Usual care |
Primary outcome
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time frame: 6 months
13 secondary outcomes
Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B)
Time frame: 3 months
Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being)
Time frame: 3, 6 months
Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time frame: 3, 6 months
Pain, quality of sleep, and nausea (single items of the FACT-B)
Time frame: 3, 6 months
Functional Assessment of Chronic Illness Therapy-Fatigue
Time frame: 3, 6 months
Survival without relapse
Time frame: 6 months
Quality of Life (SF-12 Health Survey)
Time frame: 3, 6 months
Undesirable Effects and Interactions
Time frame: 6 months
Goal Attainment Scale
Time frame: 3 months
Used complementary Therapies and their frequency
Time frame: 6 months
Expectations at Baseline
Time frame: Baseline
Satisfaction and patient-reported effectiveness
Time frame: 3, 6 months
Survival
Time frame: 6 months
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 16 Feb 2015.
- Results publication: PubMed 25555830Witt CM, Ausserer O, Baier S, Heidegger H, Icke K, Mayr O, Mitterer M, Roll S, Spizzo G, Scherer A, Thuile C, Wieser A, Schutzler L. Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial. Breast Cancer Res Treat. 2015 Jan;149(2):449-60. doi: 10.1007/s10549-014-3249-3. Epub 2015 Jan 3.
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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.
Claudia M Witt, Prof. Dr. med. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Individualized complementary medicine treatment in people with Breast Cancer, run by Charite University, Berlin, Germany at 1 site in Italy.
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 4 inclusion and 3 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 16 Feb 2015. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01458457, which also lists 1 linked publication.
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 16 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.