Ritual Training Program in HNC Patients

Cognitive Change Clinical Trial

Official title:

Effects of a Ritual Training Program in the Head and Neck Cancer Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346564
• Other study ID #: MOST 103-2629-B-255 -001
• Status: Completed
• Phase: N/A
• First received: November 6, 2017
• Last updated: November 16, 2017
• Start date: August 1, 2014
• Est. completion date: October 31, 2017

Study information

• Verified date: November 2017
• Source: Ministry of Science and Technology, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of a ritual training program in head and neck cancer (HNC) patients.

Description:

The purpose of this study will to evaluate the effects of a ritual training program on disfigurement, self-esteem, social interaction, and body image in head and neck cancer (HNC) patients.

A prospective, repeated measures, randomized controlled therapeutic intervention design was employed. The experimental group will receive a ritual training program, and the control group will receive routine care. Patients will be assessed at three time points: baseline assessment (T0), and then at 1, 2, and 3-months (T1, T2, and T3) after participating in the ritual training program or routine care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• > 20 years old,

• newly diagnosed first occurrence of HNC,

• completion of treatment and more than 3 months post-treatment

Exclusion Criteria:

• recurrence

Related Conditions & MeSH terms

• Cognitive Change
• Education

Intervention

Behavioral:
• Ritual training program
Ritual training program including education and demonstration
• Routine care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Science and Technology, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disfigurement	Observer-rated disfigurement scale (1-9, higher score indicating greater levels of self-esteem higher disfigurement)	Change from Baseline Disfigurement at 6 months
Primary	Body Image	Body Image Scale (0-30, higher scores indicate greater symptoms or distress in terms of body image concerns)	Change from Baseline Body Image at 6 months
Primary	Social Interaction	Liebowitz Social Anxiety Scale(0-72, higher scores indicate greater fear or avoidance social interaction	Change from Baseline Social Interaction at 6 months
Primary	Depression	Hospital Anxiety and Depression Scale-Depression Subscale (0-21, higher score indicates a higher level of depression).	Change from Baseline Depression at 6 months
Primary	Self-Esteem	Rosenberg Self-Esteem Scale(10-40, higher scores indicating greater levels of self-esteem)	Change from Baseline Self-Esteem at 6 months