Effects of an ritual training program in the head and neck cancer patients: a randomized controlled trial

• Register: ISRCTN
• Last refreshed on: 11 March 2019
• Main ID: ISRCTN11570710
• Date of registration: 21/11/2017
• Prospective Registration: Yes
• Primary sponsor: The Ministry of Science and Technology, Taiwan
• Public title: Effects of an ritual training program in the head and neck cancer patients: a randomized controlled trial
• Scientific title: Effects of an Ritual Training Program on body image, disfigurement, social interaction, depression, self-esteem
• Date of first enrolment: 01/12/2017
• Target sample size: 100
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11570710
• Study type: Interventional
• Study design: Interventional randomised controlled single-centre study (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Taiwan

Contacts

• Name: Shu-Ching Chen

Key inclusion & exclusion criteria

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

Exclusion criteria: Patients with cancer recurrence during completion treatment

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Head and neck cancer, survival, psychosocial dimension and quality of life
Cancer
Head and neck cancer, survival, psychosocial dimension and quality of life

Intervention(s)

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(s)

Quality of Life is measured using the UW-QOL Scale from baseline quality of life at 6 months

Secondary Outcome(s)

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

Secondary ID(s)

MOST 103-2629-B-255 -001

Source(s) of Monetary Support

Ministry of Science and Technology, Taiwan

Ethics review

Status:
Approval date:
Contact:

Chang Gung Institutional Review Board in Taiwan, 2012/07/31, ref: 100-4206B

Results

• Results available: Yes
• Date Completed: 31/12/2018