Rehabilitation Nursing Program in Otolaryngology

NCT ID: NCT05246891

Last Updated: 2022-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Rehabilitation Neck Cancer Otorhinolaryngologic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rehabilitation nursing intervention

Functional respiratory rehabilitation exercise plan. Motor exercise plan. Cardiorespiratory optimization. Early diagnosis of potential problems associated.

rehabilitation nursing

Intervention Type OTHER

Functional respiratory rehabilitation and motor exercise plan.

Rehabilitation nursing not intervention

General nursing care

rehabilitation nursing

Intervention Type OTHER

Functional respiratory rehabilitation and motor exercise plan.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rehabilitation nursing

Functional respiratory rehabilitation and motor exercise plan.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto Portugues Oncologia de Lisboa Francisco Gentil

OTHER

Sponsor Role collaborator

University of Évora

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

José Manuel Afonso Moreira

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

José JM Moreira, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Évora

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Évora

Evora, , Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21492066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27841134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30746969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24817237 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

University of Évora

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rehabilitation Outcomes Study
NCT06674889 RECRUITING NA
Effect of Exercise in Head and Neck Cancer Patients
NCT05256238 ACTIVE_NOT_RECRUITING NA
Improving Sleep in Gynecologic Cancer Survivors
NCT05044975 ACTIVE_NOT_RECRUITING NA