Clinical trial NCT05246891: Rehabilitation Nursing Program in Otolaryngology
Official title: Rehabilitation Nursing Program in Otolaryngology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rehabilitation
Neck Cancer
Otorhinolaryngologic Neoplasms
Keywords: Maxillofacial Surgery
Head and neck cancer
Otolaryngology
Lead sponsor: University of Évora
Sponsor class: OTHER
Collaborators: name: Instituto Portugues Oncologia de Lisboa Francisco Gentil
First posted: 2022-02-18
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a Head and Neck surgery after diagnosis of cancer.

Brief 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. 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%.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participants will be excluded if not be possible access of the clinical information.

Primary outcomes:
measure: Change is being assessed
timeFrame: 0 week - 4 weeks
Secondary outcomes:
measure: Impatient days
timeFrame: 0 week - 4 weeks
Other outcomes:
Locations:
city: Évora
country: Portugal
facility: University of Évora
Study officials:
affiliation: University of Évora
name: José JM Moreira, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Clarke 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.
citation: Davidson 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.
citation: Sheikh 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.