Needs Assessment Tool Integrated in Clinical Practice of Head and Neck Cancer Rehabilitation

Head and Neck Neoplasms Clinical Trial

— NEAT  

Official title:

Needs Assessment and Decision-making Tool (NEAT-decision) Integrated in a Clinical Practice to Enhance Patient Involvement in Head and Neck Cancer Rehabilitation - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443258
• Other study ID #: 05781
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: March 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study tests a needs assessment and decision-making tool with patients who are in need of rehabilitation after surgery for Head and Neck Cancer. The purpose is to enhance patient involvement in decision-making.

Description:

The study tests a needs assessment and decision-making tool with patients surgically treated for Head and Neck Cancer. The tool will be an integrated part of a new clinical practice with nursing consultations at three seperate time-points in the post-surgical period of the patients. Half of the participants will receive nursing consultations using the tool and the other half will receive standard care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: November 30, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Head and Neck Cancer

• Stage T3 or T4

• Surgically treated

• Must be able to speak and understand Danish

Exclusion Criteria:

• Treated surgically for thyroid or parotic cancers

• Referred to adjuvant radio - or chemotherapy

• Having an unstable psychiatric illness.

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Other:
• Needs assesment tool integrated in nursing consultation.
Needs assessment tool consisting of 57 items related to functional, emotional, social and existential areas guide follow-up care and referral to multidisciplinary team rehabilitation e.g. dietician; speech-pathologist; psychologist, etc

Locations

Country	Name	City	State
Denmark	Dept. Of Otorhinolaryngology, Head and Neck Surgery and Audiology	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Nurses Organisation, Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Health Related Quality of Life, from baseline to 9, 21 and until 67 days post surgery	Questionnaire measuring 35 items related to quality of life in head and neck cancer. European Organisation for Research and Treatment of Cancer Quality of Life and Head and Neck Cancer (EORTC QLQ-H&N35). Scores range from 0 - 100,, where a high score represents high quality of life. The study will measure global quality of life	Baseline; 9; 21 and 67 days post-surgery
Secondary	Change in Symptom Burden from baseline to 2, 14 and 60 days post-surgery	Questionnaire measuiring 28 items related to symptoms of head and neck cancer patients. MD Anderson Symptom Inventory Head and Neck Cancer module (MDASI-HN). Scores range from 0 - 10, where a high score represents a high symptom burden interference with daily life.	Baseline, 2, 14 and 60 days post-surgery