Life Quality and Mental State in Patients With Breast Cancer

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Other: Individualized complementary medicine treatment; Other: Individualized usual care

• Registration Number: NCT01458457
• Lead Sponsor: Charite University, Berlin, Germany

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2011-10-21
• Study First Posted: 2011-10-24
• Primary Completion: 2012-12
• Study Completion: 2013-07
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-13
• Last Update Posted: 2015-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 275

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care + Complementary Medicine	Individualized complementary medicine treatment	-
Usual care	Individualized usual care	-
Usual Care + Complementary Medicine	Individualized usual care	-

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)	6 months

Secondary Outcome Measures

Name	Time	Method
Satisfaction and patient-reported effectiveness	3, 6 months	This will only be assessed in the complementary medicine arm
Survival	6 months
Functional Assessment of Chronic Illness Therapy-Fatigue	3, 6 months
Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B)	3 months
Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)	3, 6 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)	3, 6 months
Used complementary Therapies and their frequency	6 months	This will only be assessed in the complementary medicine arm
Pain, quality of sleep, and nausea (single items of the FACT-B)	3, 6 months
Survival without relapse	6 months
Quality of Life (SF-12 Health Survey)	3, 6 months
Undesirable Effects and Interactions	6 months
Goal Attainment Scale	3 months	This outcome measures will only be assessed in the complementary medicine arm
Expectations at Baseline	Baseline	This will only be assessed in the complementary medicine group

Trial Locations

Locations (1)

Meran Hospital - Dienst fuer Komplementaermedizin; 🇮🇹 Meran, Italy