Plain English Summary
Background and study aims
Head and neck cancer (HNC) is one of the most lethal cancers. It ranks as the fifth most common cancer worldwide and is the most common neoplasm in central Asia. Males are affected significantly more often than females. Radical excision (removal of tumors) and reconstruction is the primary treatment modality for patients with head and neck cancer. Surgical resection may involve anatomical destruction and lead to varying levels of physical and psychological disturbance, especially related to change in body image and facial disfigurement. The aim of this study is to evaluate if participants who undergo a ritual training program will have better body image, less disfigurement, better social interaction and higher self-esteem than those who do not undergo a ritual training program.
Who can participate?
Adults aged 20 to 70 years old who have completed treatment for first occurrence of male and female HNC
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the ritual training program twice a week for eight weeks. This includes education and demonstrations. Those in the second group receive their routine care. Participants are followed up for their quality of life at 6 months.
What are the possible benefits and risks of participating?
Ritual training program has been demonstrated to be a safe strategy for managing change in body image and facial disfigurement. This study will not involve any invasive intervention and does not carry any risks.
Where is the study run from?
Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
January 2017 to December 2018
Who is funding the study?
The Ministry of Science and Technology (Taiwan)
Who is the main contact?
Professor Shu-Ching Chen
shuching@gw.cgust.edu.tw
Trial website
Contact information
Type
Scientific
Primary contact
Prof Shu-Ching Chen
ORCID ID
http://orcid.org/0000-0002-7921-1964
Contact details
61
Wen-Hua 1st Road
Kweishan
Taoyuan
Taoyuan
33303
Taiwan
+886 (0)3 2118999 ext. 3436
shuching@gw.cgust.edu.tw
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MOST 103-2629-B-255 -001
Study information
Scientific title
Effects of an Ritual Training Program on body image, disfigurement, social interaction, depression, self-esteem
Acronym
RTP
Study hypothesis
Patients attend an Ritual Training Program will have better body image, disfigurement, social interaction, depression, self-esteem than those who not attend an Ritual Training Program.
Ethics approval
Chang Gung Institutional Review Board in Taiwan, 2012/07/31, ref: 100-4206B
Study design
Interventional randomised controlled single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format
Condition
Head and neck cancer, survival, psychosocial dimension and quality of life
Intervention
Participants are randomly allocated to one of two groups.
Experimental: Ritual training program ritual training program for 8 weeks, biweekly. The ritual training program includes education and demonstration.
Placebo comparator group: Participants receive routine care following hospital care.
Participants are followed up at six months to assess their quality of life, body image, disfigurement, social interaction, depression and self-esteem.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Quality of Life is measured using the UW-QOL Scale from baseline quality of life at 6 months
Secondary outcome measures
1. Body Image is measured using Body Image Scale from baseline body image at 6 months
2. Disfigurement is measured using Observer-rated disfigurement scale from baseline body image at 6 months
3. Social Interaction is measured using Liebowitz Social Anxiety Scale from baseline social interaction at 6 months
4. Depression is measured using Hospital Anxiety and Depression Scale-Depression Subscale from baseline depression at 6 months
5. Self-esteem is measured using Rosenberg Self-Esteem Scale from baseline self-esteem at 6 months
Overall trial start date
01/01/2017
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 20 to 70 years
2. Newly diagnosed first occurrence of male and female HNC
3. Completion of treatment and more than 3 months post-treatment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
Patients with cancer recurrence during completion treatment
Recruitment start date
01/12/2017
Recruitment end date
30/06/2018
Locations
Countries of recruitment
Taiwan
Trial participating centre
Chang Gung Memorial Hospital
Chang Gung Medical Foundation
#5, Fusing Street, Keiwshan
Taoyuan
33303
Taiwan
Sponsor information
Organisation
The Ministry of Science and Technology, Taiwan
Sponsor details
Ministry of Science and Technology
106
Sec. 2
Heping E. Road
Taipei
10622
Taiwan
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Science and Technology, Taiwan
Alternative name(s)
Ministry of Science and Technology of Taiwan, MOST
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Taiwan
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Principal investigator: Shu-Ching Chen, PhD, Professor Department of Nursing, Chang Gung University of Science and Technology at shuching@gw.cgust.edu.tw.
Intention to publish date
01/08/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30407682