Effects of an ritual training program in the head and neck cancer patients: a randomized controlled trial
| ISRCTN | ISRCTN11570710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11570710 |
| Secondary identifying numbers | MOST 103-2629-B-255 -001 |
- Submission date
- 17/11/2017
- Registration date
- 21/11/2017
- Last edited
- 14/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
61, Wen-Hua 1st Road
Kweishan
Taoyuan
Taoyuan
33303
Taiwan
 ORCID ID |
0000-0002-7921-1964 |
|---|---|
| Phone | +886 (0)3 2118999 ext. 3436 |
| shuching@gw.cgust.edu.tw |
Study information
| Study design | Interventional randomised controlled single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format |
| Scientific title | Effects of an Ritual Training Program on body image, disfigurement, social interaction, depression, self-esteem |
| Study acronym | RTP |
| Study objectives | 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(s) | Chang Gung Institutional Review Board in Taiwan, 2012/07/31, ref: 100-4206B |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2017 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key exclusion criteria | Patients with cancer recurrence during completion treatment |
| Date of first enrolment | 01/12/2017 |
| Date of final enrolment | 30/06/2018 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
#5, Fusing Street, Keiwshan
Taoyuan
33303
Taiwan
Sponsor information
Government
Ministry of Science and Technology
106
Sec. 2
Heping E. Road
Taipei
10622
Taiwan
| Website | https://www.most.gov.tw |
|---|---|
"ROR" |
https://ror.org/02kv4zf79 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Science and Technology, R.O.C. (Taiwan), Ministry of Science and Technology of Taiwan, MOST
- Location
- Taiwan
Results and Publications
| Intention to publish date | 01/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2019 | Yes | No |
Editorial Notes
14/02/2019: Publication reference added.
23/11/2017: Internal review.
