Head and Neck CancerNCT05269342
Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer
A study testing nurse-led counseling and after intervention in people with Head and Neck Cancer and Cancer of Head and Neck, run by YU LONG HONG at 1 site in Taiwan.
Trial summary
Background: This study aimed to the postoperative patients with newly diagnosed head and neck Cancer. The nurse-led counselling and after intervention improved shoulder pain, Shoulder Disability, and Quality of Life., before 2 weeks radical neck dissection and at postoperative 2, 4, 8, and 12 weeks. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer, Cancer of Head and Neck, Head and Neck Neoplasms
- What is being tested?
- nurse-led counseling and after intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Sep 2017to 9 Sep 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged >20 years old newly diagnosed with HNC scheduled to receive surgery had no serious complications had no history of mental illness had no comorbidities had no sensory-cognitive problems could understand Chinese or Taiwanese
Who cannot join
- could not communicate or comprehend the questionnaires had a history of shoulder dysfunction before neck dissection had preexisting shoulder pain, dysfunction, or weakness had any disorders that could influence movement performance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse-led Exercise To Improve Shoulder Pain, Shoulder Disability, and Quality of Life in Postoperative Patients With Newly Diagnosed Head and Neck Cancer
Background: This study aimed to the postoperative patients with newly diagnosed head and neck Cancer. The nurse-led counselling and after intervention improved shoulder pain, Shoulder Disability, and Quality of Life., before 2 weeks radical neck dissection and at postoperative 2, 4, 8, and 12 weeks.
Methods：Participants were identified for eligibility from the otorhinolaryngology outpatient department of a medical center in eastern Taiwan. The data of 40 patients were collected between Aug 1, 2017, and Jul 31, 2018. 40 participants were randomly assigned to an experimental (n = 20) and a control group (n = 20). The experimental group received the nurse counselling and after intervention exercise intervention , and the control group received usual care. Study tools used were the shoulder pain and disability indices, University of Washington Quality of Life Questionnaire.
Read the detailed description
Head and neck cancer (HNCs) is malignancies . Globally, HNCs was the seventh most common cancer in 2018. In taiwan, have high incidences . Primary treatments for HNCs are surgery alone or in combination with radiation . The radical neck dissection and radiotherapy inevitably damage nerves and muscles, resulting in various complications such as shoulder pain and disability; the shoulder disability and chronic neck pain occur following radical neck dissection, these complications may considerably limit the individual's capacity to undertake various tasks, affecting daily physical activities. Immediate postoperative rehabilitation has been advocated to improve these complications in HNC participants . But rticipants often fail to achieve this thresh old, which emphasizes the need to change their inactive behaviour.
Nurses are involved in patient care and have the necessary skills and knowledge about the medical and practical aspects of head and neck cancer treatment . Nurses can provide information, support and coaching to HNC participants .Nurses are in a key position to deliver an intervention to improve QoL . The investigators designed a randomised controlled trial (RCT) to investigate the effectiveness of a comprehensive 12weeks nurse-led intervention, the nurse counselling and after intervention (NUCAI), in HNC participants follow exercise intervention
- Being tested
- nurse-led counseling and after intervention
- Keywords
- Head and Neck Neoplasms
- 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.
nurse-led counseling and after interventionBehavioural
the nurse-led counseling and after intervention exercise (NUCAI), in patients with HNC
| Study group | Role | What they receive |
|---|---|---|
| the nurse-led counseling and after intervention exercise | Experimental | The NUCAI aims to help patients manage themselves physically and psychologically by giving support, education, and exercise tracking.
The participants in the control group were care as usual.Intervention group were the nurse-led counseling and after intervention exercise (NUCAI), in patients with HNC. Receives: Behavioral: nurse-led counseling and after intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic and Illness-related Information
age, sex, educational level, and cancer stage
Measured: 2 weeks preoperatively
Secondary outcomes (1)
shoulder pain and disability indices
shoulder pain and disability
Measured: 2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start14 Sep 2017
- Primary completion16 Jun 2018
- Study completion9 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- YU LONG HONG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YU LONG HONG, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269342
- Sponsor's protocol ID
- HYL
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Exercise To Improve Shoulder Pain, Shoulder Disability, and Quality of Life in Postoperative Patients With Newly Diagnosed Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05269342
- Acronym / sponsor ID
- HYL
- Keywords
- Head and Neck Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- YU LONG HONGUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 16 Jun 2018 (actual)
- Study completion
- 9 Sep 2018 (actual)
- First posted
- 8 Mar 2022 (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.
Background: This study aimed to the postoperative patients with newly diagnosed head and neck Cancer. The nurse-led counselling and after intervention improved shoulder pain, Shoulder Disability, and Quality of Life., before 2 weeks radical neck dissection and at postoperative 2, 4, 8, and 12 weeks.
Methods：Participants were identified for eligibility from the otorhinolaryngology outpatient department of a medical center in eastern Taiwan. The data of 40 patients were collected between Aug 1, 2017, and Jul 31, 2018. 40 participants were randomly assigned to an experimental (n = 20) and a control group (n = 20). The experimental group received the nurse counselling and after intervention exercise intervention , and the control group received usual care. Study tools used were the shoulder pain and disability indices, University of Washington Quality of Life Questionnaire.
Detailed description
Head and neck cancer (HNCs) is malignancies . Globally, HNCs was the seventh most common cancer in 2018. In taiwan, have high incidences . Primary treatments for HNCs are surgery alone or in combination with radiation . The radical neck dissection and radiotherapy inevitably damage nerves and muscles, resulting in various complications such as shoulder pain and disability; the shoulder disability and chronic neck pain occur following radical neck dissection, these complications may considerably limit the individual's capacity to undertake various tasks, affecting daily physical activities. Immediate postoperative rehabilitation has been advocated to improve these complications in HNC participants . But rticipants often fail to achieve this thresh old, which emphasizes the need to change their inactive behaviour.
Nurses are involved in patient care and have the necessary skills and knowledge about the medical and practical aspects of head and neck cancer treatment . Nurses can provide information, support and coaching to HNC participants .Nurses are in a key position to deliver an intervention to improve QoL . The investigators designed a randomised controlled trial (RCT) to investigate the effectiveness of a comprehensive 12weeks nurse-led intervention, the nurse counselling and after intervention (NUCAI), in HNC participants follow exercise intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the nurse-led counseling and after intervention exercise | Experimental | Behavioral: nurse-led counseling and after interventionThe NUCAI aims to help patients manage themselves physically and psychologically by giving support, education, and exercise tracking. The participants in the control group were care as usual.Intervention group were the nurse-led counseling and after intervention exercise (NUCAI), in patients with HNC. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged >20 years old newly diagnosed with HNC scheduled to receive surgery had no serious complications had no history of mental illness had no comorbidities had no sensory-cognitive problems could understand Chinese or Taiwanese
Key exclusion criteria (1 listed)
- could not communicate or comprehend the questionnaires had a history of shoulder dysfunction before neck dissection had preexisting shoulder pain, dysfunction, or weakness had any disorders that could influence movement performance.
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 |
|---|---|---|
| nurse-led counseling and after interventionthe nurse-led counseling and after intervention exercise (NUCAI), in patients with HNC | Behavioural | the nurse-led counseling and after intervention exercise |
Primary outcome
Demographic and Illness-related Information
Time frame: 2 weeks preoperatively
age, sex, educational level, and cancer stage
1 secondary outcome
shoulder pain and disability indices
Time frame: 2 weeks preoperatively (baseline) and then 2, 4, 8, and 12 weeks postoperatively
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 8 Mar 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-led counseling and after intervention in people with Head and Neck Cancer and Cancer of Head and Neck, run by YU LONG HONG at 1 site in 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 1 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Demographic and Illness-related Information (time frame: 2 weeks preoperatively). 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 8 Mar 2022.