COMplementary Hand-foot Massage to Improve Experience of illneSs Trial (COMMIS)

April 21, 2016 updated by: M.J.M.T. Wolters, Zuyderland Medisch Centrum

The COMplementary hand-foot Massage to Improve experience of ilneSs trial (COMMIS trial) is a prospective, randomized trial and executed at a Western referral Centre: Zuyderland Medical Centre located Sittard-Geleen, The Netherlands concerning patients who underwent surgery for gastrointestinal malignancy. During 5 consecutive days, the intervention group received postoperatively hand-foot massage administered by trained volunteers.

The aim of this study is to investigate the effect of complementary therapies concerning quality of life, pain, nausea, fatigue, sleeping problems, mood and stress in patients who underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The COMplementary hand-foot Massage to Improve experience of ilneSs trial (COMMIS trial) is a prospective, randomized trial and executed at a Western referral Centre: Zuyderland Medical Centre located Sittard-Geleen, The Netherlands.

The aim of this study is to investigate the effect of complementary therapies concerning quality of life, pain, nausea, fatigue, sleeping problems, mood and stress in patients who underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal). Patients had to be >18 years of age. Exclusion criteria were patients who were not able to undergo massage, not able to sign informed consent or speaking the native language, deaf patients and patients having a hand- or foot disorder.

Primary outcome measure is quality of life, including psychological state, level of functioning in daily life and pain. Secondary outcome measures are patient satisfaction about the received hospital care and the need for complementary medicine.

Recruitment takes place during the second preoperative appointment at the clinic, where eligible patients receive oral and written information about the study. One week after this conversation, patients are asked if they are interested to participate. If so, informed consent is obtained and remaining questions are answered.

Randomization takes place by the randomization program ALEA. It was not possible to blind investigator, patient, physician or nurse.

Patient groups consist of an intervention group (51 patients) and a control group (51 patients). The intervention group receives postoperatively during 5 consecutive days hand-foot massage from volunteers who are trained by a professional. It was not possible to receive massage in the weekends because of the absence of the volunteers. The technique comprised standard 'Swedish' massage, which means applying kneading and strokes to soft tissues and muscles. The intervention was performed by applying ethereal oils from Volatile, which consisted of 10% jojoba and 90% almond oil.

The control group receives the usual care.

Patients from both groups are asked to fill in questionnaires about health status/health related quality of life (EQ-5D-3L) and anxiety/depression (HADS-NL) at specific moments in time. Those include one week pre-operatively (baseline), post-operative day (POD) 1, POD3, POD5 and when they return at the policlinic after hospital's discharge. Before discharge, every patient is asked to fill in a questionnaire about patient satisfaction concerning the received hospital care as well.

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Not Applicable

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal).
  • Patients >18 years of age.

Exclusion Criteria:

  • Patients who were not able to undergo massage
  • Patients who were not able to sign informed consent
  • Patients who did not speak the native language
  • Deaf patients
  • Patients having a hand- or foot disorder.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Therapy standard
Patients receive usual postoperative care
Other: Usual post-operative care
Usual post-operative care concerning patients who underwent surgery because of gastrointestinal malignancy
EXPERIMENTAL: Therapy standard + hand-foot massage
Patients receive usual postoperative care and hand-foot massage
Other: Usual post-operative care
Usual post-operative care concerning patients who underwent surgery because of gastrointestinal malignancy
Other: Hand-foot massage
Hand-foot massage administered during 5 consecutive days postoperatively by trained volunteers, concerning patients who underwent surgery because of gastrointestinal malignancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in quality of life as assessed by EuroQol-5D-L3 (EQ-5D-L3) questionnaire
Time Frame: From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks

To assess health-related quality of life, patients were asked to fill in the short generic EQ-5D-L3 questionnaire. Patients have to fill in those questionnaires at certain moments in time, from the day of surgery until the first visit at the policlinic after hospital's discharge. Patients are hospitalized about 1-2 weeks and their first policlinical visit after discharge is most often set at 1-2 weeks. That's why the time frame is estimated at 4 weeks.

This questionnaire comprises health-related quality of life questions, e.g. state of mobility, self-care, daily activities, mood and pain.
From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks
Change from baseline in anxiety and depression as assessed by Hospital Anxiety and Depression Scale (HADS) questionnaire
Time Frame: From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks
Anxiety and depression is measured by using the Hospital Anxiety and Depression Scale (HADS). Patients have to fill in those questionnaires at certain moments in time, from the day of surgery until the first visit at the policlinic after hospital's discharge. Patients are hospitalized about 1-2 weeks and their first policlinical visit after discharge is most often set at 1-2 weeks. That's why the time frame is estimated at 4 weeks.
From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction about the received hospital care and hand-foot massage (if applicable) as assessed by questionnaire
Time Frame: From day of surgery until hospital's discharge assessed up to 2 weeks
Patients are asked to fill in a questionnaire about the received hospital care and hand-foot massage (if applicable) at hospital's discharge. Patients have to fill in this questionnaires at hospital's discharge. Patients are hospitalized for 1-2 weeks, which means that the estimated time frime would be about 2 weeks (from day of surgery until date of discharge). That's why the time frame is estimated at 2 weeks.
From day of surgery until hospital's discharge assessed up to 2 weeks
Patients' opinion and need about hand-foot massage's utility as assessed by questionnaire
Time Frame: From day of surgery until policlinical visit after hospital's discharge assessed up to 2 weeks
Patients are asked to fill in a questionnaire about their opinion about receiving hand-foot massage at hospital's discharge, even if they themselves were not randomized in the intervention group. Patients have to fill in this questionnaires at hospital's discharge. Patients are hospitalized for 1-2 weeks, which means that the estimated time frime would be about 2 weeks (from day of surgery until date of discharge). That's why the time frame is estimated at 2 weeks.
From day of surgery until policlinical visit after hospital's discharge assessed up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuyderland Medisch Centrum

Investigators

  • Principal Investigator: Jan H. Stoot, Dr., Zuyderland MC

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

March 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (ESTIMATE)

April 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMMIS

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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