Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients

June 8, 2020 updated by: Cesar Agostinis-Sobrinho, Klaipėda University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Klaipeda, Lithuania, LT
        • Cesar Agostinis-Sobrinho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A - Music Therapy
Two section a week of music therapy
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.
EXPERIMENTAL: B - Art Therapy
Two section a week of Art therapy
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.
EXPERIMENTAL: C - Dance-Movement Therapy
Two section a week of Dance-Movement Therapy
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.
EXPERIMENTAL: D - Bibliotherapy
Two section a week of Bibliotherapy
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.
EXPERIMENTAL: E - Physical Activity
Two section a week of systematized physical activity
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental Health
Time Frame: Mental health (score)changes over 4 weeks intervention
Questionnaire to assess mental health
Mental health (score)changes over 4 weeks intervention
Quality of Life
Time Frame: Quality of life changes (score) over 4 weeks intervention
Questionnaire to assess quality of life
Quality of life changes (score) over 4 weeks intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klaipėda University

Collaborators

Ministry of Health of The Republic of Lithuania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

December 30, 2020

Study Completion (ANTICIPATED)

October 30, 2021

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (ACTUAL)

June 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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