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Clinical Trials/NCT04427215
NCT04427215
Unknown
Phase 1

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

Klaipėda University1 site in 1 country250 target enrollmentJuly 1, 2020
ConditionsBreast Cancer

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Klaipėda University
Enrollment
250
Locations
1
Primary Endpoint
Mental Health
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
October 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Klaipėda University
Responsible Party
Principal Investigator
Principal Investigator

Cesar Agostinis-Sobrinho

Principal Investigator

Klaipėda University

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

Outcomes

Primary Outcomes

Mental Health

Time Frame: Mental health (score)changes over 4 weeks intervention

Questionnaire to assess mental health

Quality of Life

Time Frame: Quality of life changes (score) over 4 weeks intervention

Questionnaire to assess quality of life

Study Sites (1)

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