NCT05246891

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

March 7, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

February 6, 2022

Last Update Submit

February 18, 2022

Conditions

RehabilitationNeck CancerOtorhinolaryngologic Neoplasms

Keywords

Maxillofacial SurgeryHead and neck cancerOtolaryngology

Outcome Measures

Primary Outcomes (1)

  • Change is being assessed

    Self-care: Barthel Index (0 points-100 points)

    0 week - 4 weeks

Secondary Outcomes (1)

  • Impatient days

    0 week - 4 weeks

Study Arms (2)

Rehabilitation nursing intervention

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

Other: rehabilitation nursing

Rehabilitation nursing not intervention

General nursing care

Other: rehabilitation nursing

Interventions

rehabilitation nursingOTHER

Functional respiratory rehabilitation and motor exercise plan.

Rehabilitation nursing interventionRehabilitation nursing not intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Évora

Evora, 7000, Portugal

Location

Related Publications (4)

  • 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.

    PMID: 21492066BACKGROUND

  • 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.

    PMID: 27841134BACKGROUND

  • 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.

    PMID: 30746969BACKGROUND

  • 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.

    PMID: 24817237BACKGROUND

MeSH Terms

Conditions

Head and Neck NeoplasmsOtorhinolaryngologic Neoplasms

Interventions

Rehabilitation Nursing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Nursing CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • José JM Moreira, MSc

    University of Évora

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2022

First Posted

February 18, 2022

Study Start

July 1, 2018

Primary Completion

October 31, 2020

Study Completion

December 31, 2020

Last Updated

March 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)