COMplementary Hand-foot Massage to Improve Experience of illneSs Trial (COMMIS)
Primary Purpose
Gastrointestinal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Usual post-operative care
Hand-foot massage
Sponsored by
About this trial
This is an interventional supportive care trial for Gastrointestinal Cancer focused on measuring Complementary therapies, Massage, Gastrointestinal cancer
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Therapy standard
Therapy standard + hand-foot massage
Arm Description
Patients receive usual postoperative care
Patients receive usual postoperative care and hand-foot massage
Outcomes
Primary Outcome Measures
Change from baseline in 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.
Change from baseline in 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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02741401
First Posted
April 4, 2016
Last Updated
April 21, 2016
Sponsor
Zuyderland Medisch Centrum
1. Study Identification
Unique Protocol Identification Number
NCT02741401
Brief Title
COMplementary Hand-foot Massage to Improve Experience of illneSs Trial
Acronym
COMMIS
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zuyderland Medisch Centrum
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
Keywords
Complementary therapies, Massage, Gastrointestinal cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapy standard
Arm Type
Active Comparator
Arm Description
Patients receive usual postoperative care
Arm Title
Therapy standard + hand-foot massage
Arm Type
Experimental
Arm Description
Patients receive usual postoperative care and hand-foot massage
Intervention Type
Other
Intervention Name(s)
Usual post-operative care
Intervention Description
Usual post-operative care concerning patients who underwent surgery because of gastrointestinal malignancy
Intervention Type
Other
Intervention Name(s)
Hand-foot massage
Intervention Description
Hand-foot massage administered during 5 consecutive days postoperatively by trained volunteers, concerning patients who underwent surgery because of gastrointestinal malignancy
Primary Outcome Measure Information:
Title
Change from baseline in quality of life as assessed by EuroQol-5D-L3 (EQ-5D-L3) questionnaire
Description
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.
Time Frame
From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks
Title
Change from baseline in anxiety and depression as assessed by Hospital Anxiety and Depression Scale (HADS) questionnaire
Description
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.
Time Frame
From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks
Secondary Outcome Measure Information:
Title
Patient satisfaction about the received hospital care and hand-foot massage (if applicable) as assessed by questionnaire
Description
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.
Time Frame
From day of surgery until hospital's discharge assessed up to 2 weeks
Title
Patients' opinion and need about hand-foot massage's utility as assessed by questionnaire
Description
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.
Time Frame
From day of surgery until policlinical visit after hospital's discharge assessed up to 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan H. Stoot, Dr.
Organizational Affiliation
Zuyderland MC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
COMplementary Hand-foot Massage to Improve Experience of illneSs Trial
We'll reach out to this number within 24 hrs