Condition category
Cancer
Date applied
17/11/2017
Date assigned
21/11/2017
Last edited
23/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

https://www.most.gov.tw

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

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/11/2017: Internal review.