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

NCT02880202 | Completed

• 1 other identifier: 15-007515
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to evaluate the impact of massage therapy in hospice patients.

Conditions

Pain; Anxiety; Depression; Quality of Life

Keywords

Massage Therapy; Hospice; Integrative Medicine; Palliative Care; Caregivers

Outcome Measures

Primary Outcomes (1)

• Change in Edmonton Symptom Assessment System - Revised

  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 therapy. If there is any improvement, the massage therapy will be considered a success since any improvement will be seen as beneficial.

  Baseline to 3 weeks

Secondary Outcomes (4)

• Change in Edmonton Symptom Assessment System - Revised (Other symptoms)

  Baseline to 3 weeks

• Change in Linear Analogue Self Assessment (LASA)

  Baseline to 3 weeks

• Change in Patient Health Questionnaire for Depression and Anxiety (PHQ-4)

  Baseline to 3 weeks

• Change in Pearlin role overload measure (ROM)

  Baseline to 3 weeks

Study Arms (1)

Massage Therapy

OTHER

Massage therapy for hospice patients.

Other: Massage Therapy

Interventions

Massage Therapy OTHER

The massage therapy is provided by certified massage therapists and delivered in the home setting. Techniques and duration of massage therapy is customized based on input from the patient and/or caregiver at the start of the session regarding nature and location of discomfort and other symptoms, and based on other factors such as contra-indications/complicating factors, medical issues, and additional diagnoses. The number of massage therapy interventions range from 2-3, 1 week apart, with each session lasting between 20-45 minutes in duration.

Massage Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Clinically determined by hospice staff to be appropriate for massage therapy (ESAS-r scores of 5 or greater on pain, depression, anxiety, or best well-being)
• Place of residence within 30 minutes of downtown Rochester
• Patient or caregiver must be able to participate in brief interviews and complete questionnaires (verbally or physically)

You may not qualify if:

• \. Patients ineligible for massage therapy due to complexity of medical care including complex wound and multiple drains

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Depression

Interventions

Massage

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Maria I Lapid, MD

  Professor of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)