NCT01458457

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

1.6 years

First QC Date

October 21, 2011

Last Update Submit

February 13, 2015

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    6 months

Secondary Outcomes (13)

  • Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B)

    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)

    3, 6 months

  • Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    3, 6 months

  • Pain, quality of sleep, and nausea (single items of the FACT-B)

    3, 6 months

  • Functional Assessment of Chronic Illness Therapy-Fatigue

    3, 6 months

  • +8 more secondary outcomes

Study Arms (2)

Usual care

ACTIVE COMPARATOR
Other: Individualized usual care

Usual Care + Complementary Medicine

ACTIVE COMPARATOR
Other: Individualized complementary medicine treatmentOther: Individualized usual care

Interventions

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

Usual Care + Complementary Medicine
Individualized usual careOTHER

Patients get usual care from their general practitioners/specialized physicians

Usual Care + Complementary MedicineUsual care

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • complementary treatment at the Hospital Meran in the last 6 months
  • no German or Italian language ability
  • participation in other study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meran Hospital - Dienst fuer Komplementaermedizin

Meran, 39012, Italy

Location

Related 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, 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.

    PMID: 25555830RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Claudia M Witt, Prof. Dr. med.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

October 21, 2011

First Posted

October 24, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations

IT(1)