Clinical trial NCT04427215: Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients
Official title: Effects of Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Klaipėda University
Sponsor class: OTHER
Collaborators: name: Ministry of Health of The Republic of Lithuania
First posted: 2020-06-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 5 intervention groups (music therapy, art therapy, dance-movement therapy, physical activity, bibliotherapy) and 1 control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: During cancer treatment, several patient experience substantial psychological distress, mainly depression and anxiety, which can persist over years after completion of treatment.

Complementary and alternative medicine (CAM) has been in use among cancer patients for a long time and several types of CAM that are practiced in various parts of the world.

However, the effectiveness of different CAM therapies on mental health is still limited.

Therefore, the investigators want to assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of cancer patients as well as their caregiver

Detailed description: During cancer treatment, several patient experience substantial psychological distress, mainly depression and anxiety, which can persist over years after completion of treatment. These psychological impairments can aggravate symptom burden and can seriously affect health-related quality of life. Likewise, the diagnosis of cancer has not only a significant impact on the affected patients, but also on their families, and may cause emotional responses of shock, doubt, anxiety, and depression.

Complementary and alternative medicine (CAM) has been in use among cancer patients for a long time and several types of CAM that are practiced in various parts of the world. In the general among Lithuanian adult population, the use of CAM begins to seem common and the country claim for guidelines researches and to test the effectiveness of this practice to support the use of some CAM therapies on mental health of patients as well as their families.

In the St. Francis Oncology Center in Klaipeda some CAM have been applied aimed to increase the recovery and quality of life in the patients and their families. The effectiveness of different CAM therapies (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity ) on mental health and recovery of cancer patients as well as on caregiving experiences and mental health of partners of cancer patients, it will be of great value to improve and provide a more effective service and the quality of caring in this patient as well as the continuing work of the Francis Oncology Center in Klaipeda and partners, with more higher scientific excellence and quality .

Objectives

· To assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of cancer patients as well as their caregiver.

Eligibility criteria: Inclusion Criteria:

- All adult woman with breast cancer diagnoses and their primary family caregiver

Exclusion Criteria:

* Insufficient physical capacity
* Severe mental disorder
* Inability ti give informed consent

Primary outcomes:
measure: Mental Health
timeFrame: Mental health (score)changes over 4 weeks intervention
measure: Quality of Life
timeFrame: Quality of life changes (score) over 4 weeks intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Klaipeda
country: Lithuania
facility: Cesar Agostinis-Sobrinho
Study officials:
References: