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Completed

NCT Number: NCT02880202

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

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

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Key information

Conditions

Pain Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 26, 2016
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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