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Completed

NCT Number: NCT03346564

Ritual Training Program in HNC Patients

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

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Key information

Conditions

Education Cognitive Change Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

20 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • recurrence

Treatment and study plan

Ritual training program

Behavioral

Ritual training program including education and demonstration

Routine Care

Behavioral

Other names: Routine care following hospital care

Primary outcomes

  1. Disfigurement

    Time frame: Change from Baseline Disfigurement at 6 months

    Observer-rated disfigurement scale (1-9, higher score indicating greater levels of self-esteem higher disfigurement)

  2. Body Image

    Time frame: 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)

  3. Social Interaction

    Time frame: Change from Baseline Social Interaction at 6 months

    Liebowitz Social Anxiety Scale(0-72, higher scores indicate greater fear or avoidance social interaction

  4. Depression

    Time frame: Change from Baseline Depression at 6 months

    Hospital Anxiety and Depression Scale-Depression Subscale (0-21, higher score indicates a higher level of depression).

  5. Self-Esteem

    Time frame: Change from Baseline Self-Esteem at 6 months

    Rosenberg Self-Esteem Scale(10-40, higher scores indicating greater levels of self-esteem)

Sponsors and collaborators

Lead sponsor

Ministry of Science and Technology, Taiwan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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