COMplementary Hand-foot Massage to Improve Experience of illneSs Trial

NCT02741401 | Unknown

• 1 other identifier: COMMIS
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Gastrointestinal Cancer

Keywords

Complementary therapies; Massage; Gastrointestinal cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks

• 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.

  From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks

Secondary Outcomes (2)

• Patient satisfaction about the received hospital care and hand-foot massage (if applicable) as assessed by questionnaire

  From day of surgery until hospital's discharge assessed up to 2 weeks

• Patients' opinion and need about hand-foot massage's utility as assessed by questionnaire

  From day of surgery until policlinical visit after hospital's discharge assessed up to 2 weeks

Study Arms (2)

Therapy standard

ACTIVE COMPARATOR

Patients receive usual postoperative care

Other: Usual post-operative care

Therapy standard + hand-foot massage

EXPERIMENTAL

Patients receive usual postoperative care and hand-foot massage

Other: Usual post-operative care; Other: Hand-foot massage

Interventions

Usual post-operative care OTHER

Usual post-operative care concerning patients who underwent surgery because of gastrointestinal malignancy

Therapy standard; Therapy standard + hand-foot massage

Hand-foot massage OTHER

Hand-foot massage administered during 5 consecutive days postoperatively by trained volunteers, concerning patients who underwent surgery because of gastrointestinal malignancy

Therapy standard + hand-foot massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal).
• Patients \>18 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Jan H. Stoot, Dr.

  Zuyderland MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. J.H.M.B. Stoot

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 18, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 22, 2016

Record last verified: 2016-04