- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02742415
Caring Hand Massage - an Intervention in Cancer Patients Undergoing Chemotherapy in an Outpatient Setting - a Pilot Study
March 6, 2017 updated by: Susanne M. Cutshall, Mayo Clinic
Since there is a limited amount of evidence on the feasibility and outcomes on the use of hand massage in patients undergoing cancer treatment, the purpose of this study is to evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing chemotherapy, and to measure its influence on their symptoms.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients age 18 - 80
- Patient receiving treatment on Mayo Clinic's Chemotherapy Outpatient Clinic
- Able to speak English and complete surveys
- Able to read, understand and sign inform consent.
Exclusion Criteria:
- Patient has rash, sores, wounds, incision or other skin conditions on hands
- Unable to give consent or complete the surveys
- Already having received previous hand massage
- Pregnant women. (As verbalized by participant)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cancer patients receiving hand massage
Caring Hand massage will be provided to the outpatients undergoing chemotherapy
|
Caring Hand Massage is a hand massage therapy program with several steps and techniques.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of symptom scores
Time Frame: baseline to 45 minutes.
|
We will record the number of patients approached hand massage to those that accept and were able to get a full hand massage during their time in the chemotherapy area
|
baseline to 45 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susanne M Cutshall, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (ACTUAL)
February 1, 2017
Study Completion (ACTUAL)
February 1, 2017
Study Registration Dates
First Submitted
April 14, 2016
First Submitted That Met QC Criteria
April 14, 2016
First Posted (ESTIMATE)
April 19, 2016
Study Record Updates
Last Update Posted (ACTUAL)
March 8, 2017
Last Update Submitted That Met QC Criteria
March 6, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 16-001790
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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