Rehabilitation Nursing Program in Otolaryngology

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).

Study Overview

• Status: Completed
• Conditions: Otorhinolaryngologic Neoplasms; Rehabilitation; Neck Cancer
• Intervention / Treatment: Other: rehabilitation nursing

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 Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• Portugal
  • Évora, Portugal, 7000
    • University of Évora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a Head and Neck surgery after diagnosis of cancer.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rehabilitation nursing intervention; Functional respiratory rehabilitation exercise plan. Motor exercise plan. Cardiorespiratory optimization. Early diagnosis of potential problems associated.	Other: rehabilitation nursing; Functional respiratory rehabilitation and motor exercise plan.
Rehabilitation nursing not intervention; General nursing care	Other: rehabilitation nursing; Functional respiratory rehabilitation and motor exercise plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change is being assessed	Self-care: Barthel Index (0 points-100 points)	0 week - 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impatient days	Days of hospitalization	0 week - 4 weeks

Collaborators and Investigators

• Sponsor: University of Évora
• Collaborators: Instituto Portugues Oncologia de Lisboa Francisco Gentil
• Investigators: Principal Investigator: José JM Moreira, MSc, University of Évora

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 6, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Head and neck cancer; Otolaryngology; Maxillofacial Surgery
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Otorhinolaryngologic Diseases; Head and Neck Neoplasms; Otorhinolaryngologic Neoplasms
• Other Study ID Numbers: University of Évora

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No