Ritual Training Program in HNC Patients

Not Applicable

Completed

• Conditions: Education; Cognitive Change
• Interventions: Behavioral: Ritual training program; Behavioral: Routine care

• Registration Number: NCT03346564
• Lead Sponsor: Ministry of Science and Technology, Taiwan

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-08-01
• Primary Completion: 2017-07-31
• Study Completion: 2017-10-31
• Status Verified: 2017-11
• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-16
• Last Update Submitted: 2017-11-16
• Study First Posted: 2017-11-17
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• > 20 years old,
• newly diagnosed first occurrence of HNC,
• completion of treatment and more than 3 months post-treatment

Exclusion Criteria

• recurrence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ritual training program	Ritual training program	ritual training program for 8 weeks, biweekly
Routine care	Routine care	Routine care following hospital

Primary Outcome Measures

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