Handicraft classes for colorectal cancer patients with chemotherapy-induced neuropathy: improving neuropathic symptoms in hands through exercising the hand muscles

ISRCTN	ISRCTN16586956
DOI	https://doi.org/10.1186/ISRCTN16586956
Secondary identifying numbers	1.0

Submission date: 21/07/2018
Registration date: 31/07/2018
Last edited: 30/07/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the common reasons that colorectal cancer patients cannot maintain their routine chemotherapy schedules. CIPN involves pain, numbness, tingling and sensitivity to cold in the hands and feet and is often very painful and stressful. Some medications are used for pain relief, but they are often not effective. As a result, there has been renewed interest in alternative therapies that stimulate the hand muscles, such as exercise or massage to relieve the neuropathic symptoms.
This study aims to look at the effectiveness of a handicraft program as rehabilitation for colorectal cancer patients with CIPN, which involves basic craftwork to encourage the use of the minor muscles of the hands to make and decorate handicrafts.

Who can participate?
Adults with colorectal cancer who received chemotherapy

What does the study involve?
This rehabilitation program comes in the form of the handicraft class, which involves decorating crafts such as a hand mirror, a business card holder, a table clock, and a picture frame with lacquerware, using Korean traditional lacquerworks. This is performed once a week, for 2 hours per each session, for a total of 4 weeks. All volunteers will participate in same program. The effectiveness of this program will be evaluated by using a questionnaire.

What are the possible benefits and risks of participating?
The possible benefit of participating is that it may improve neuropathic symptoms in participants, along with being able to keep the handicrafts made during the program. The only possible risk of participation is physical injury from craft tools such as knives; however, this is unlikely as the program is supervised by professional instructors, specialized nurses and a surgeon.

Where is the study run from?
Ewha Womans University College of Medicine Mokdong Hospital (South Korea)

When is the study starting and how long is it expected to run for?
February 2012 to August 2018

Who is funding the study?
Ewha Womans University College of Medicine Mokdong Hospital (South Korea)

Who is the main contact?
Kyung Sook Hong
happying4ever@gmail.com

Contact information

Dr Kyung Sook Hong
Scientific

1071 Anyangcheon-ro, Yangcheon-gu
Seoul
07985
Korea, South

Study information

Study design	Observational longitudinal study
Primary study design	Observational
Secondary study design	Longitudinal study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	Efficacy of a REhabilitation PROgram using minor muscles in colorectal cancer patients with chemotherapy-induced Neuropathy: preliminary study
Study acronym	REPRON
Study objectives	The rehabilitation program using minor muscles of hands can improve the symptoms of the chemotherapy-induced peripheral neuropathy.
Ethics approval(s)	Ewha Womans University Mokdong Hospital, 29/03/2018, EUMC 2018-03-029-002
Health condition(s) or problem(s) studied	Colorectal cancer treated with chemotherapy
Intervention	The aim of this program is to promote the use of the minor muscles of the hands by decorating handicrafts such as a hand mirror, a business card holder, a table clock, and a picture frame with lacquerware, using the Korean traditional lacquerworks. Lacquerworks were made as follows: First, participants designed his/her craft, then cut the lacquerware into various sizes and shapes according to the design. The more complicated the sizes or shapes of design was, more scrupulous and careful attention was required to handle the lacquerware. Prepared lacquerware was attached on the appropriate locations of hand mirror, a business card holder, a table clock, and a picture frame using glue. This process exercised the minor muscles of the hands and induced the effects of thermal therapy. This was performed once a week, for 2 hours per each session, for a total of 4 weeks through outpatient clinics. The program was conducted under the supervision of a professional instructor, specialized nurses and a surgeon.
Intervention type	Other
Primary outcome measure	Improvement of neuropathic symptoms, assessed using the Korean version of the Short-form McGill Pain Questionnaire (SF-MPQ-2) at the baseline and after completion of the fourth handicraft class.
Secondary outcome measures	N/A
Overall study start date	01/02/2012
Completion date	31/08/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	17
Key inclusion criteria	1. Diagnosed with colorectal cancer 2. Followed up with chemotherapy after surgical treatment
Key exclusion criteria	1. Diabetes mellitus 2. Neurological diseases that could affect neuropathic symptoms
Date of first enrolment	01/03/2012
Date of final enrolment	30/04/2012

Locations

Countries of recruitment

Korea, South

Study participating centre

Ewha Womans University College of Medicine

1071 Anyangcheon-ro, Yangcheon-gu
Seoul
07985
Korea, South

Sponsor information

Ewha Womans University College of Medicine
University/education

1071 Anyangcheon-ro, Yangcheon-gu
Seoul
07985
Korea, South

"ROR"	https://ror.org/053fp5c05

Funders

Funder type

Not defined

Investigator initated and funded

No information available

Results and Publications

Intention to publish date	01/09/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	We plan to submit to a peer-reviewed journal in 2018.
IPD sharing plan	The datasets generated/analysed in this study are not expected to be made available as the datasets will be discarded according to the decision of the institutional review board.