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

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ClinicalTrials.gov Identifier: NCT02880202
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Maria I. Lapid, M.D., Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Pain Anxiety Depression Quality of Life Other: Massage Therapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Massage Therapy on the Quality of Life of Hospice Patients
Study Start Date : August 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Massage Therapy
Massage therapy for hospice patients.
Other: Massage Therapy
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. 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)
  3. Place of residence within 30 minutes of downtown Rochester
  4. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880202


Contacts
Contact: Maria I Lapid, MD 507-284-2933 Lapid.Maria@mayo.edu
Contact: Barbara A Hall, BS 507-266-5374 hall.barbara2@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Barbara A Hall, BS    507-266-5374    hall.barbara2@mayo.edu   
Principal Investigator: Maria I Lapid, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Maria I Lapid, MD Professor of Psychiatry

Responsible Party: Maria I. Lapid, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02880202     History of Changes
Other Study ID Numbers: 15-007515
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maria I. Lapid, M.D., Mayo Clinic:
Massage Therapy
Hospice
Integrative Medicine
Palliative Care
Caregivers