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

Gastrointestinal Cancer Clinical Trial

Status Enrolling by invitation

Clinical Trial Summary

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).

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

• NCT number: NCT02741401
• Study type: Interventional
• Source: Zuyderland Medisch Centrum
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 2016
• Completion date: December 2016