Clinical trial NCT01458457: Life Quality and Mental State in Patients With Breast Cancer
Official title: Life Quality and Mental State in Patients With Breast Cancer - a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy
First posted: 2011-10-24
Enrollment: 275
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: 6 months
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B)
timeFrame: 3 months
measure: Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being)
timeFrame: 3, 6 months
measure: Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: 3, 6 months
measure: Pain, quality of sleep, and nausea (single items of the FACT-B)
timeFrame: 3, 6 months
measure: Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: 3, 6 months
measure: Survival without relapse
timeFrame: 6 months
measure: Quality of Life (SF-12 Health Survey)
timeFrame: 3, 6 months
measure: Undesirable Effects and Interactions
timeFrame: 6 months
measure: Goal Attainment Scale
timeFrame: 3 months
measure: Used complementary Therapies and their frequency
timeFrame: 6 months
measure: Expectations at Baseline
timeFrame: Baseline
measure: Satisfaction and patient-reported effectiveness
timeFrame: 3, 6 months
measure: Survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Meran
country: Italy
facility: Meran Hospital - Dienst fuer Komplementaermedizin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia M Witt, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.