Ritual Training Program in HNC Patients

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

Detailed Description
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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.

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

Conditions
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Education, Cognitive Change

Intervention / Treatment
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* Behavioral: Ritual training program
* Behavioral: Routine care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 20 years old, newly diagnosed first occurrence of HNC, completion of treatment and more than 3 months post-treatment Exclusion Criteria: recurrence

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ritual training program<br>ritual training program for 8 weeks, biweekly | Behavioral: Ritual training program<br>* Ritual training program including education and demonstration<br>|
| Placebo Comparator: Routine care<br>Routine care following hospital | Behavioral: Routine care<br> <br> * Other names: Routine care following hospital care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disfigurement | Observer-rated disfigurement scale (1-9, higher score indicating greater levels of self-esteem higher disfigurement) | Change from Baseline Disfigurement at 6 months | 
| 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 | 
| 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 | 
| 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 | 
| Self-Esteem | Rosenberg Self-Esteem Scale(10-40, higher scores indicating greater levels of self-esteem) | Change from Baseline Self-Esteem at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck cancer, Ritual training, disfigurement, body image