EducationNCT03346564
Ritual Training Program in HNC Patients
A study testing Ritual training program and Routine care in people with Education and Cognitive Change, run by Ministry of Science and Technology, Taiwan.
Trial summary
To evaluate the effects of a ritual training program in head and neck cancer (HNC) patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Education, Cognitive Change
- What is being tested?
- Ritual training program and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 20 years old,
- newly diagnosed first occurrence of HNC,
- completion of treatment and more than 3 months post-treatment
Who cannot join
- recurrence
About this study
Official title: 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.
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.
- Conditions
- Education, Cognitive Change
- Being tested
- Ritual training program, Routine care
- Keywords
- Head and neck cancer, Ritual training, disfigurement, body image
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritual training programBehavioural
Ritual training program including education and demonstration
Routine careBehavioural
Also called Routine care following hospital care
| Study group | Role | What they receive |
|---|---|---|
| Ritual training program | Experimental | ritual training program for 8 weeks, biweekly Receives: Behavioral: Ritual training program |
| Routine care | Placebo comparator | Routine care following hospital Receives: Behavioral: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disfigurement
Observer-rated disfigurement scale (1-9, higher score indicating greater levels of self-esteem higher disfigurement)
Measured: 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)
Measured: 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
Measured: 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).
Measured: Change from Baseline Depression at 6 months
Self-Esteem
Rosenberg Self-Esteem Scale(10-40, higher scores indicating greater levels of self-esteem)
Measured: Change from Baseline Self-Esteem at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Aug 2014
- Primary completion31 Jul 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shu-Ching Chen, Ministry of Science and Technology, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346564
- Sponsor's protocol ID
- MOST 103-2629-B-255 -001
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Ritual Training Program in the Head and Neck Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03346564
- Acronym / sponsor ID
- MOST 103-2629-B-255 -001
- Conditions
- Education, Cognitive Change
- Keywords
- Head and neck cancer, Ritual training, disfigurement, body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ministry of Science and Technology, TaiwanOther government
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effects of a ritual training program in head and neck cancer (HNC) patients.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ritual training program | Experimental | Behavioral: Ritual training programritual training program for 8 weeks, biweekly |
| Routine care | Placebo comparator | Behavioral: Routine careRoutine care following hospital |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 20 years old,
- newly diagnosed first occurrence of HNC,
- completion of treatment and more than 3 months post-treatment
Key exclusion criteria (1 listed)
- recurrence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritual training programRitual training program including education and demonstration | Behavioural | Ritual training program |
| Routine careAlso: Routine care following hospital care | Behavioural | Routine care |
Primary outcome
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)
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)
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
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).
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ritual training program and Routine care in people with Education and Cognitive Change, run by Ministry of Science and Technology, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disfigurement (time frame: Change from Baseline Disfigurement at 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.