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
MOST 103-2629-B-255 -001
Effects of an Ritual Training Program on body image, disfigurement, social interaction, depression, self-esteem
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.
Chang Gung Institutional Review Board in Taiwan, 2012/07/31, ref: 100-4206B
Interventional randomised controlled single-centre study
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format
Head and neck cancer, survival, psychosocial dimension and quality of life
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.
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
Overall trial end date
Reason abandoned (if study stopped)
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
Target number of participants
Participant exclusion criteria
Patients with cancer recurrence during completion treatment
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Chang Gung Memorial Hospital
Chang Gung Medical Foundation #5, Fusing Street, Keiwshan
The Ministry of Science and Technology, Taiwan
Ministry of Science and Technology
Heping E. Road
Ministry of Science and Technology, Taiwan
Ministry of Science and Technology of Taiwan, MOST
Funding Body Type
Funding Body Subtype
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 firstname.lastname@example.org.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30407682