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CompletedNCT03346564Updated Nov 17, 2017

Ritual Training Program in HNC Patients

An interventional study of Ritual training program and Routine care in Education and Cognitive Change, sponsored by Ministry of Science and Technology, Taiwan. Completed. Open to male participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by Ministry of Science and Technology, Taiwan · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Aug 2014, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Education
  • Cognitive Change

Keywords

  • Head and neck cancer
  • Ritual training
  • disfigurement
  • body image
03

In context

Head and Neck Neoplasms

2,713 studies on the registry are indexed under Head and Neck Neoplasms; 596 are open to participants now.

This study's enrollment of 100 is above the median of 46 across 2,033 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Ministry of Science and Technology, Taiwan is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • recurrence
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Ritual training program

    ritual training program for 8 weeks, biweekly

    Behavioral: Ritual training program

  • Placebo comparator
    Routine care

    Routine care following hospital

    Behavioral: Routine care

Interventions

  • BehavioralRitual training program

    Ritual training program including education and demonstration

  • BehavioralRoutine care

    Also known as: Routine care following hospital care

06

What researchers measure

Primary outcomes

  1. Disfigurement

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

    Time frame: Change from Baseline Disfigurement at 6 months

  2. Body Image

    Body Image Scale (0-30, higher scores indicate greater symptoms or distress in terms of body image concerns)

    Time frame: Change from Baseline Body Image at 6 months

  3. Social Interaction

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

    Time frame: Change from Baseline Social Interaction at 6 months

  4. Depression

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

    Time frame: Change from Baseline Depression at 6 months

  5. Self-Esteem

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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2014 to primary completion in Jul 2017, 35 months.

Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's 35 months is close to that.

Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2017
First posted
Nov 17, 2017
StartActual
Aug 1, 2014
Primary completionActual
Jul 31, 2017
CompletionActual
Oct 31, 2017
Last update
Nov 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03346564
Lead sponsor
Ministry of Science and Technology, Taiwan
Responsible party
Shu-Ching Chen (Professor, Ministry of Science and Technology, Taiwan) — Principal investigator
First posted
Nov 17, 2017
Start date
Aug 1, 2014
Primary completion
Jul 31, 2017
Completion
Oct 31, 2017
Last update
Nov 17, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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