Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 1
Locations
Lithuania
Study Type
Interventional
Intervention
Complementary and alternative medicines
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
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
Sites / Locations
- Cesar Agostinis-Sobrinho
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
A - Music Therapy
B - Art Therapy
C - Dance-Movement Therapy
D - Bibliotherapy
E - Physical Activity
Arm Description
Two section a week of music therapy
Two section a week of Art therapy
Two section a week of Dance-Movement Therapy
Two section a week of Bibliotherapy
Two section a week of systematized physical activity
Outcomes
Primary Outcome Measures
Mental Health
Questionnaire to assess mental health
Quality of Life
Questionnaire to assess quality of life
Secondary Outcome Measures
Full Information
NCT ID
NCT04427215
First Posted
June 2, 2020
Last Updated
June 8, 2020
Sponsor
Klaipėda University
Collaborators
Ministry of Health of The Republic of Lithuania
1. Study Identification
Unique Protocol Identification Number
NCT04427215
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klaipėda University
Collaborators
Ministry of Health of The Republic of Lithuania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
5 intervention groups (music therapy, art therapy, dance-movement therapy, physical activity, bibliotherapy) and 1 control group.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The participants will be randomized
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A - Music Therapy
Arm Type
Experimental
Arm Description
Two section a week of music therapy
Arm Title
B - Art Therapy
Arm Type
Experimental
Arm Description
Two section a week of Art therapy
Arm Title
C - Dance-Movement Therapy
Arm Type
Experimental
Arm Description
Two section a week of Dance-Movement Therapy
Arm Title
D - Bibliotherapy
Arm Type
Experimental
Arm Description
Two section a week of Bibliotherapy
Arm Title
E - Physical Activity
Arm Type
Experimental
Arm Description
Two section a week of systematized physical activity
Intervention Type
Other
Intervention Name(s)
Complementary and alternative medicines
Intervention Description
Five types of Complementary and alternative medicines (Music Therapy, Art Therapy, Dance-Movement Therapy, Bibliotherapy, Physical Activity) will be applied twice a week.
Primary Outcome Measure Information:
Title
Mental Health
Description
Questionnaire to assess mental health
Time Frame
Mental health (score)changes over 4 weeks intervention
Title
Quality of Life
Description
Questionnaire to assess quality of life
Time Frame
Quality of life changes (score) over 4 weeks intervention
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cesar Agostinis-Sobrinho
City
Klaipeda
ZIP/Postal Code
LT
Country
Lithuania
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients
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