RehabilitationNCT05246891
Rehabilitation Nursing Program in Otolaryngology
An observational study of Rehabilitation and Neck Cancer, run by University of Évora at 1 site in Portugal.
Trial summary
The European Commission's current political guidelines demonstrate into a joint plan aimed at improving and controlling cancer disease. Head and neck cancer (HNC) are the sixth most common cancer worldwide. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rehabilitation, Neck Cancer, Otorhinolaryngologic Neoplasms
- What is being tested?
- rehabilitation nursing
- How many people
- 151 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jul 2018to 31 Dec 2020
- Phase
- Observational
- 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 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing a Head and Neck surgery after diagnosis of cancer.
Who may be able to join
- Undergoing a different type of surgery: 1-Neck dissection, 2-Total laryngectomy with neck dissection, 3-Pelviglossomandibulectomy with neck dissection and tracheotomy, 4-Pelviglossomandibulectomy with neck dissection, pectorals major flap and tracheotomy.
Who cannot join
- Participants will be excluded if not be possible access of the clinical information.
Trial locations and contacts
1 site in 1 country.
About this study
The European Commission's current political guidelines demonstrate into a joint plan aimed at improving and controlling cancer disease. Head and neck cancer (HNC) are the sixth most common cancer worldwide. The surgery is one of the most effective treatments, however it significantly compromises the self-care and functional capacity of the patients, so the intervention the Rehabilitation Nurse (RN) is essential.
Objective: Compare the degree of dependence in discharge from patients undergoing HNC surgery with RN intervention versus general nursing care (not RN intervention). The specific objective is to analyze the role of confounders in the effect of the RN intervention on the patient dependence.
Seventy-nine patients with RN intervention who undergoing a different type of surgery (1-Neck dissection, 2-Total laryngectomy with neck dissection, 3-Pelviglossomandibulectomy with neck dissection and tracheotomy, 4-Pelviglossomandibulectomy with neck dissection, pectorals major flap and tracheotomy) and all patients who undergoing the same type of surgery without RN intervention (n=72).
Read the detailed description
Seventy-nine patients with RN intervention who undergoing a different type of surgery (1-Neck dissection, 2-Total laryngectomy with neck dissection, 3-Pelviglossomandibulectomy with neck dissection and tracheotomy, 4-Pelviglossomandibulectomy with neck dissection, pectorals major flap and tracheotomy) and all patients who undergoing the same type of surgery without RN intervention (n=72). Differences between groups were calculated using non-parametric tests Chi-square for categorical variables and Mann-Whitney U for numeric variable. After correlation tests between variables, statistical analysis was carried out through Poisson regression to a significance level of 5%.
- Conditions
- Rehabilitation, Neck Cancer, Otorhinolaryngologic Neoplasms
- Being tested
- rehabilitation nursing
- Keywords
- Maxillofacial Surgery, Head and neck cancer, Otolaryngology
- Medical subject headings
- Head and Neck Neoplasms, Otorhinolaryngologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation nursingOther
Functional respiratory rehabilitation and motor exercise plan.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation nursing intervention | Functional respiratory rehabilitation exercise plan. Motor exercise plan. Cardiorespiratory optimization. Early diagnosis of potential problems associated. Receives: Other: rehabilitation nursing | |
| Rehabilitation nursing not intervention | General nursing care Receives: Other: rehabilitation nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is being assessed
Self-care: Barthel Index (0 points-100 points)
Measured: 0 week - 4 weeks
Secondary outcomes (1)
Impatient days
Days of hospitalization
Measured: 0 week - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jul 2018
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Portugues Oncologia de Lisboa Francisco Gentil
- Responsible party
- Principal investigator, José Manuel Afonso Moreira, University of Évora
- Investigators
- José JM Moreira, MSc, Principal investigator, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246891
- Sponsor's protocol ID
- University of Évora
- Status last verified
- Feb 2022
- First submitted
- 6 Feb 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahlberg A, Engstrom T, Nikolaidis P, Gunnarsson K, Johansson H, Sharp L, Laurell G. Early self-care rehabilitation of head and neck cancer patients. Acta Otolaryngol. 2011 May;131(5):552-61. doi: 10.3109/00016489.2010.532157.
PubMed 21492066Clarke P, Radford K, Coffey M, Stewart M. Speech and swallow rehabilitation in head and neck cancer: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol. 2016 May;130(S2):S176-S180. doi: 10.1017/S0022215116000608.
PubMed 27841134Davidson A, Williams J. Factors affecting quality of life in patients experiencing facial disfigurement due to surgery for head and neck cancer. Br J Nurs. 2019 Feb 14;28(3):180-184. doi: 10.12968/bjon.2019.28.3.180.
PubMed 30746969Sheikh A, Shallwani H, Ghaffar S. Postoperative shoulder function after different types of neck dissection in head and neck cancer. Ear Nose Throat J. 2014 Apr-May;93(4-5):E21-6.
PubMed 24817237
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Nursing Program in Otolaryngology
- ClinicalTrials.gov ID
- NCT05246891
- Acronym / sponsor ID
- University of Évora
- Conditions
- Rehabilitation, Neck Cancer, Otorhinolaryngologic Neoplasms
- Keywords
- Maxillofacial Surgery, Head and neck cancer, Otolaryngology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Collaborators
- Instituto Portugues Oncologia de Lisboa Francisco Gentil
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Feb 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.
The European Commission's current political guidelines demonstrate into a joint plan aimed at improving and controlling cancer disease. Head and neck cancer (HNC) are the sixth most common cancer worldwide. The surgery is one of the most effective treatments, however it significantly compromises the self-care and functional capacity of the patients, so the intervention the Rehabilitation Nurse (RN) is essential.
Objective: Compare the degree of dependence in discharge from patients undergoing HNC surgery with RN intervention versus general nursing care (not RN intervention). The specific objective is to analyze the role of confounders in the effect of the RN intervention on the patient dependence.
Seventy-nine patients with RN intervention who undergoing a different type of surgery (1-Neck dissection, 2-Total laryngectomy with neck dissection, 3-Pelviglossomandibulectomy with neck dissection and tracheotomy, 4-Pelviglossomandibulectomy with neck dissection, pectorals major flap and tracheotomy) and all patients who undergoing the same type of surgery without RN intervention (n=72).
Detailed description
Seventy-nine patients with RN intervention who undergoing a different type of surgery (1-Neck dissection, 2-Total laryngectomy with neck dissection, 3-Pelviglossomandibulectomy with neck dissection and tracheotomy, 4-Pelviglossomandibulectomy with neck dissection, pectorals major flap and tracheotomy) and all patients who undergoing the same type of surgery without RN intervention (n=72). Differences between groups were calculated using non-parametric tests Chi-square for categorical variables and Mann-Whitney U for numeric variable. After correlation tests between variables, statistical analysis was carried out through Poisson regression to a significance level of 5%.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation nursing intervention | – | Other: rehabilitation nursingFunctional respiratory rehabilitation exercise plan. Motor exercise plan. Cardiorespiratory optimization. Early diagnosis of potential problems associated. |
| Rehabilitation nursing not intervention | – | Other: rehabilitation nursingGeneral nursing care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a Head and Neck surgery after diagnosis of cancer.
Key inclusion criteria (1 listed)
- Undergoing a different type of surgery: 1-Neck dissection, 2-Total laryngectomy with neck dissection, 3-Pelviglossomandibulectomy with neck dissection and tracheotomy, 4-Pelviglossomandibulectomy with neck dissection, pectorals major flap and tracheotomy.
Key exclusion criteria (1 listed)
- Participants will be excluded if not be possible access of the clinical information.
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 |
|---|---|---|
| rehabilitation nursingFunctional respiratory rehabilitation and motor exercise plan. | Other | Rehabilitation nursing intervention, Rehabilitation nursing not intervention |
Primary outcome
Change is being assessed
Time frame: 0 week - 4 weeks
Self-care: Barthel Index (0 points-100 points)
1 secondary outcome
Impatient days
Time frame: 0 week - 4 weeks
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 7 Mar 2022.
- Background: PubMed 21492066Ahlberg A, Engstrom T, Nikolaidis P, Gunnarsson K, Johansson H, Sharp L, Laurell G. Early self-care rehabilitation of head and neck cancer patients. Acta Otolaryngol. 2011 May;131(5):552-61. doi: 10.3109/00016489.2010.532157.
- Background: PubMed 27841134Clarke P, Radford K, Coffey M, Stewart M. Speech and swallow rehabilitation in head and neck cancer: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol. 2016 May;130(S2):S176-S180. doi: 10.1017/S0022215116000608.
- Background: PubMed 30746969Davidson A, Williams J. Factors affecting quality of life in patients experiencing facial disfigurement due to surgery for head and neck cancer. Br J Nurs. 2019 Feb 14;28(3):180-184. doi: 10.12968/bjon.2019.28.3.180.
- Background: PubMed 24817237Sheikh A, Shallwani H, Ghaffar S. Postoperative shoulder function after different types of neck dissection in head and neck cancer. Ear Nose Throat J. 2014 Apr-May;93(4-5):E21-6.
- 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.
José JM Moreira, MSc principal investigator
University of Évora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rehabilitation and Neck Cancer, run by University of Évora at 1 site in Portugal.
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 7 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 Portugal. 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?
Change is being assessed (time frame: 0 week - 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05246891, which also lists 4 linked publications.
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 7 Mar 2022.