Ritual Training Program in HNC Patients

NCT ID: NCT03346564

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2017-10-31

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.

Conditions

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Education Cognitive Change

Keywords

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Head and neck cancer Ritual training disfigurement body image

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Ritual training program

ritual training program for 8 weeks, biweekly

Group Type EXPERIMENTAL

Ritual training program

Intervention Type BEHAVIORAL

Ritual training program including education and demonstration

Routine care

Routine care following hospital

Group Type PLACEBO_COMPARATOR

Routine care

Intervention Type BEHAVIORAL

Interventions

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Ritual training program

Ritual training program including education and demonstration

Intervention Type BEHAVIORAL

Routine care

Intervention Type BEHAVIORAL

Other Intervention Names

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Routine care following hospital care

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Shu-Ching Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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MOST 103-2629-B-255 -001

Identifier Type: -

Identifier Source: org_study_id