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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
Zuyderland Medisch Centrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastrointestinal Cancer focused on measuring Complementary therapies, Massage, Gastrointestinal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 4, 2016
    Last Updated
    April 21, 2016
    Sponsor
    Zuyderland Medisch Centrum
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    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

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