- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02880202
Impact of Massage Therapy on the Quality of Life of Hospice Patients
December 21, 2018 updated by: Maria I. Lapid, M.D., Mayo Clinic
This is a pilot study to evaluate the impact of massage therapy in hospice patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
As an integrative therapy, there is growing evidence that massage therapy can be an effective therapeutic tool for relief of pain and non-pain symptoms in hospice and palliative care patients.
Massage therapy can provide comfort, relaxation, and improve quality of life for patients.
The primary aim of the study is to gather data on the effects of complementary massage therapy on patient's symptoms and quality of life.
The study goal is to improve patient symptoms of pain, anxiety, depression, and quality of life through the use of massage therapy provided to hospice patients.
Questionnaires would be utilized before and after each massage intervention and would quantify symptom and quality of life levels.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
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
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
1. Patients ineligible for massage therapy due to complexity of medical care including complex wound and multiple drains
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Massage Therapy
Massage therapy for hospice patients.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Edmonton Symptom Assessment System - Revised
Time Frame: 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 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Edmonton Symptom Assessment System - Revised (Other symptoms)
Time Frame: 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.
|
Baseline to 3 weeks
|
Change in Linear Analogue Self Assessment (LASA)
Time Frame: 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.
|
Baseline to 3 weeks
|
Change in Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
Time Frame: 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.
|
Baseline to 3 weeks
|
Change in Pearlin role overload measure (ROM)
Time Frame: 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.
|
Baseline to 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria I Lapid, MD, Professor of Psychiatry
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
August 1, 2016
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
August 18, 2016
First Submitted That Met QC Criteria
August 22, 2016
First Posted (Estimate)
August 26, 2016
Study Record Updates
Last Update Posted (Actual)
December 26, 2018
Last Update Submitted That Met QC Criteria
December 21, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 15-007515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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