Ritual Training Program in HNC Patients

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

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

Study Overview

• Status: Completed
• Conditions: Cognitive Change; Education
• Intervention / Treatment: Behavioral: Ritual training program; Behavioral: Routine care

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ritual training program; ritual training program for 8 weeks, biweekly	Behavioral: Ritual training program; Ritual training program including education and demonstration
Placebo Comparator: Routine care; Routine care following hospital	Behavioral: Routine care; Other Names: Routine care following hospital care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Head and neck cancer; body image; Ritual training; disfigurement
• Other Study ID Numbers: MOST 103-2629-B-255 -001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No