Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients

NCT ID: NCT04427215

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-10-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

A - Music Therapy

Two section a week of music therapy

Group Type: EXPERIMENTAL

Complementary and alternative medicines

Intervention Type: OTHER

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

B - Art Therapy

Two section a week of Art therapy

Group Type: EXPERIMENTAL

Complementary and alternative medicines

Intervention Type: OTHER

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

C - Dance-Movement Therapy

Two section a week of Dance-Movement Therapy

Group Type: EXPERIMENTAL

Complementary and alternative medicines

Intervention Type: OTHER

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

D - Bibliotherapy

Two section a week of Bibliotherapy

Group Type: EXPERIMENTAL

Complementary and alternative medicines

Intervention Type: OTHER

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

E - Physical Activity

Two section a week of systematized physical activity

Group Type: EXPERIMENTAL

Complementary and alternative medicines

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health of The Republic of Lithuania

UNKNOWN

Sponsor Role: collaborator

Klaipėda University

OTHER

Sponsor Role: lead

Responsible Party

Cesar Agostinis-Sobrinho

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cesar Agostinis-Sobrinho

Klaipėda, , Lithuania

Countries

Lithuania

Other Identifiers

S-169

Identifier Type: -

Identifier Source: org_study_id