Life Quality and Mental State in Patients With Breast Cancer

Breast Cancer Clinical Trial

— BBK  

Official title:

Life Quality and Mental State in Patients With Breast Cancer - a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458457
• Other study ID #: BBK
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2011
• Last updated: February 13, 2015
• Start date: May 2011
• Est. completion date: July 2013

Study information

• Verified date: February 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• complementary treatment at the Hospital Meran in the last 6 months

• no German or Italian language ability

• participation in other study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Individualized complementary medicine treatment
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 care
Patients get usual care from their general practitioners/specialized physicians

Locations

Country	Name	City	State
Italy	Meran Hospital - Dienst fuer Komplementaermedizin	Meran

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Witt CM, Außerer O, Baier S, Heidegger H, Icke K, Mayr O, Mitterer M, Roll S, Spizzo G, Scherer A, Thuile C, Wieser A, Schützler L. Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)		6 months	No
Secondary	Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B)		3 months	No
Secondary	Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being)		3, 6 months	No
Secondary	Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)		3, 6 months	No
Secondary	Pain, quality of sleep, and nausea (single items of the FACT-B)		3, 6 months	No
Secondary	Functional Assessment of Chronic Illness Therapy-Fatigue		3, 6 months	No
Secondary	Survival without relapse		6 months	No
Secondary	Quality of Life (SF-12 Health Survey)		3, 6 months	No
Secondary	Undesirable Effects and Interactions		6 months	Yes
Secondary	Goal Attainment Scale	This outcome measures will only be assessed in the complementary medicine arm	3 months	No
Secondary	Used complementary Therapies and their frequency	This will only be assessed in the complementary medicine arm	6 months	No
Secondary	Expectations at Baseline	This will only be assessed in the complementary medicine group	Baseline	No
Secondary	Satisfaction and patient-reported effectiveness	This will only be assessed in the complementary medicine arm	3, 6 months	No
Secondary	Survival		6 months	No