Life Quality and Mental State in Patients With Breast Cancer (BBK)

Charité University Medicine Berlin

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Other: Individualized complementary medicine treatment; Other: Individualized usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01458457

BBK

Details and patient eligibility

About

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

Enrollment: 275 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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275 participants in 2 patient groups

Usual care

Active Comparator group

Treatment:

Other: Individualized usual care

Usual Care + Complementary Medicine

Active Comparator group

Treatment:

Other: Individualized complementary medicine treatment

Other: Individualized usual care