Impact of Massage Therapy and Music Therapy on the Quality of Life of Hospice Patients

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT03217682

Collaborator

(none)

Enrollment

Location

Arms

51.2

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a cohort study where subjects will receive either massage therapy or music therapy interventions to evaluate their impact on hospice patients.

Condition or Disease	Intervention/Treatment	Phase
Pain Anxiety Depression Quality of Life	Other: Music Therapy Other: Massage Therapy	N/A

Detailed Description

There is growing evidence that integrative therapies such as massage therapy and music therapy can be effective therapeutic tools for relief of pain and non-pain symptoms in hospice and palliative care patients. Massage and music therapies can provide comfort, relaxation, and improve quality of life for patients. The investigator's primary aim is to compare the effects of massage and music therapies on the quality of life of hospice patients. The overall goal is to further improve pain, depression, anxiety, and poor well-being or quality of life in hospice patients through the use of integrative therapies, specifically massage and music therapies, as add-on to standard hospice clinical care. Patients will be assigned to either the massage therapy or music therapy cohort. Questionnaires will be utilized before and after each massage or music therapy intervention to quantify symptom and quality of life levels.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

After the patient has been registered into the study, they will be assigned to either the music therapy or massage therapy cohort. The music therapy cohort will be available to the first 30 patients and 30 caregivers accrued. Upon reaching 60 subjects enrolled, the music therapy cohort will close to accrual and the massage therapy cohort will open to accrual. Once the massage therapy cohort has enrolled 30 patients and 30 caregivers, the massage therapy cohort will close to accrual and the study will be closed to all further accrual.After the patient has been registered into the study, they will be assigned to either the music therapy or massage therapy cohort. The music therapy cohort will be available to the first 30 patients and 30 caregivers accrued. Upon reaching 60 subjects enrolled, the music therapy cohort will close to accrual and the massage therapy cohort will open to accrual. Once the massage therapy cohort has enrolled 30 patients and 30 caregivers, the massage therapy cohort will close to accrual and the study will be closed to all further accrual.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Impact of Massage Therapy and Music Therapy on the Quality of Life of Hospice Patients

Actual Study Start Date :

Dec 4, 2017

Actual Primary Completion Date :

Mar 11, 2022

Actual Study Completion Date :

Mar 11, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Music Therapy Music therapy twice a week for two weeks, each session lasting approximately 45 min-1 hr	Other: Music Therapy Music therapy sessions
Experimental: Massage Therapy Massage therapy twice a week for two weeks, each session lasting approximately 45 min-1 hr	Other: Massage Therapy Massage therapy sessions

Arm

Intervention/Treatment

Experimental: Music Therapy

Music therapy twice a week for two weeks, each session lasting approximately 45 min-1 hr

Other: Music Therapy

Music therapy sessions

Experimental: Massage Therapy

Massage therapy twice a week for two weeks, each session lasting approximately 45 min-1 hr

Other: Massage Therapy

Massage therapy sessions

Outcome Measures

Primary Outcome Measures

Change in Edmonton Symptom Assessment System - Revised [Baseline to 3 weeks]
The primary endpoints are patient pain, depression, anxiety and wellbeing as measured by ESAS-r. Pro-rated area under the curve (AUC) statistics will be calculated for all individual items and total scores. The pro-rated AUC for ESAS-r measured pain, depression, anxiety, and wellbeing will all be utilized individually to assess the primary endpoint. The pro-rated AUC will be compared to the assessment score prior to any massage or music therapy. If there is any improvement, the therapy will be considered a success since any improvement will be seen as beneficial.

Secondary Outcome Measures

Change in Edmonton Symptom Assessment System - Revised (Other symptoms) [Baseline to 3 weeks]
Secondary endpoints include all other symptoms (tiredness, drowsiness, nausea, lack of appetite, shortness of breath) as measured by the ESAS-r. Similar analysis will be conducted for all other endpoints as was conducted for the primary outcome. Pro-rated area under the curve (AUC) statistics will be calculated for all individual items and total scores.
Change in Linear Analogue Self Assessment (LASA) [Baseline to 3 weeks]
Secondary endpoints include symptoms as measured by the LASA (overall quality of life [QOL], mental well-being, physical well-being, emotional well-being, social activity, spiritual well-being, pain frequency, pain severity, fatigue, and social support). LASA items are stand alone, thus no scoring is necessary, but individual LASA items may be transposed so lower scores mean worse symptoms and higher scores mean less symptoms. This will allow consistency and thus easier data interpretation. Pro-rated area under the curve (AUC) statistics will be calculated for all individual items and total scores. Similar analysis will be conducted for all other endpoints as was conducted for the primary outcome.
Change in Patient Health Questionnaire for Depression and Anxiety (PHQ-4) [Baseline to 3 weeks]
Secondary endpoints include depression and anxiety symptoms as measured by the PHQ-4. Similar analysis will be conducted for all other endpoints as was conducted for the primary outcome.
Change in Pearlin role overload measure (ROM) [Baseline to 3 weeks]
Secondary endpoints include caregiver stress as measured by the ROM. Pro-rated area under the curve (AUC) statistics will be calculated for all individual items and total scores. Similar analysis will be conducted for all other endpoints as was conducted for the primary outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is currently enrolled in Mayo Clinic Hospice
Age 18 years or older
ESAS-r scores of 5 or greater on pain, depression, anxiety, or best well-being (clinical assessment by hospice nursing staff)
Patient or caregiver must be able to participate in brief interviews and complete questionnaires (verbally or physically)