Clinical trial NCT02741401: COMplementary Hand-foot Massage to Improve Experience of illneSs Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Cancer
Keywords: Complementary therapies
Massage
Gastrointestinal cancer
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in quality of life as assessed by EuroQol-5D-L3 (EQ-5D-L3) questionnaire
timeFrame: From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks
measure: Change from baseline in anxiety and depression as assessed by Hospital Anxiety and Depression Scale (HADS) questionnaire
timeFrame: From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks
Secondary outcomes:
measure: Patient satisfaction about the received hospital care and hand-foot massage (if applicable) as assessed by questionnaire
timeFrame: From day of surgery until hospital's discharge assessed up to 2 weeks
measure: Patients' opinion and need about hand-foot massage's utility as assessed by questionnaire
timeFrame: From day of surgery until policlinical visit after hospital's discharge assessed up to 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Zuyderland MC
name: Jan H. Stoot, Dr.
role: PRINCIPAL_INVESTIGATOR
References: