COMplementary Hand-foot Massage to Improve Experience of illneSs Trial

Gastrointestinal Cancer Clinical Trial

— COMMIS  

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02741401
• Other study ID #: COMMIS
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 4, 2016
• Last updated: April 15, 2016
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: Zuyderland Medical Centre
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 102
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Other:
• Usual post-operative care
Usual post-operative care but without administering hand-foot massage concerning patients who underwent surgery because of gastrointestinal malignancy
• Usual post-operative care in combination with hand-foot massage
Hand-foot massage administered during 5 consecutive days postoperatively by trained volunteers, concerning patients who underwent surgery because of gastrointestinal malignancy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life as assessed by EuroQol-5D-L3 (EQ-5D-L3) questionnaire	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	No
Primary	Anxiety and depression as assessed by Hospital Anxiety and Depression Scale (HADS) questionnaire	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	No
Secondary	Patient satisfaction about the received hospital care and hand-foot massage (if applicable) as assessed by questionnaire	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	No
Secondary	Patients' opinion and need about hand-foot massage's utility as assessed by questionnaire	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	No