Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients

NCT04427215 | Unknown Phase 1

• 1 other identifier: S-169
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Mental Health

  Questionnaire to assess mental health

  Mental health (score)changes over 4 weeks intervention

• Quality of Life

  Questionnaire to assess quality of life

  Quality of life changes (score) over 4 weeks intervention

Study Arms (5)

A - Music Therapy

EXPERIMENTAL

Two section a week of music therapy

Other: Complementary and alternative medicines

B - Art Therapy

EXPERIMENTAL

Two section a week of Art therapy

Other: Complementary and alternative medicines

C - Dance-Movement Therapy

EXPERIMENTAL

Two section a week of Dance-Movement Therapy

Other: Complementary and alternative medicines

D - Bibliotherapy

EXPERIMENTAL

Two section a week of Bibliotherapy

Other: Complementary and alternative medicines

E - Physical Activity

EXPERIMENTAL

Two section a week of systematized physical activity

Other: Complementary and alternative medicines

Interventions

Complementary and alternative medicines OTHER

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

A - Music Therapy; B - Art Therapy; C - Dance-Movement Therapy; D - Bibliotherapy; E - Physical Activity

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All adult woman with breast cancer diagnoses and their primary family caregiver

You may not qualify if:

• Insufficient physical capacity
• Severe mental disorder
• Inability ti give informed consent

Sponsors & Collaborators

• Klaipėda University: lead
• Ministry of Health of The Republic of Lithuania: collaborator

Study Sites (1)

Cesar Agostinis-Sobrinho

Klaipėda, LT, Lithuania

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Complementary Therapies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants will be randomized
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 5 intervention groups (music therapy, art therapy, dance-movement therapy, physical activity, bibliotherapy) and 1 control group.

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 11, 2020
• Study Start: July 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: October 30, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)