Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Effects of Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients and Their Family Caregivers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04427215
• Other study ID #: S-169
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 1, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: June 2020
• Source: Klaipeda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: October 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Complementary and alternative medicines
Five types of Complementary and alternative medicines (Music Therapy, Art Therapy, Dance-Movement Therapy, Bibliotherapy, Physical Activity) will be applied twice a week.

Locations

Country	Name	City	State
Lithuania	Cesar Agostinis-Sobrinho	Klaipeda

Sponsors (2)

Lead Sponsor	Collaborator
Klaipeda University	Ministry of Health of The Republic of Lithuania

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental Health	Questionnaire to assess mental health	Mental health (score)changes over 4 weeks intervention
Primary	Quality of Life	Questionnaire to assess quality of life	Quality of life changes (score) over 4 weeks intervention

External Links

•   Project blog at university level