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Completed

NCT Number: NCT03443258

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

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.

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. Of Otorhinolaryngology, Head and Neck Surgery and Audiology

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Needs assesment tool integrated in nursing consultation.

Other

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

Primary outcomes

  1. Change in Health Related Quality of Life, from baseline to 9, 21 and until 67 days post surgery

    Time frame: Baseline; 9; 21 and 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

Secondary outcomes

  1. Change in Symptom Burden from baseline to 2, 14 and 60 days post-surgery

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Danish Nurses Organisation
  • Novo Nordisk A/S

Registry information

Official study 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

Acronym: NEAT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2018
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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