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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Other: Needs assesment tool integrated in nursing consultation.

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Dept. Of Otorhinolaryngology, Head and Neck Surgery and Audiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (IG); Patients receive needs assessment tool integrated in nursing consultation in accordance with requirements by Danish Health and Medicine Board follow-up program for HNC patients. The consultation consists of 6 steps 1. Welcoming patient; 2. Introducing patient to assessment tool; 3. Discuss symptoms and concerns patient wishes to discuss; 4. Follow up on patients symptoms, concerns and emotional reactions/problems; 5. Accompany/support patient during appointment with surgeon and in cooperation with patient and surgeon ensure that problems arising from the tool needing medical attention are focused on; 6. Continue the consultation after appointment with surgeon; refer patient to multi-disciplinary team members when needed	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
No Intervention: Control Group (CG); CG will receive standard care according to the Danish Health and Medicine Board's follow-up program for HNC patients. At present this is done by a staff nurse interviewing the patient, who is a member of the rehabilitation team who perform nursing consultations. The interview takes place after the appointment with the surgeon. The nurse refers the patient to physical rehabilitation if needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Novo Nordisk A/S; Danish Nurses Organisation
• Investigators: Principal Investigator: Annelise Mortensen, MSA, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• Mortensen A, Wessel I, Rogers SN, Tolver A, Jarden M. Needs assessment in patients surgically treated for head and neck cancer-a randomized controlled trial. Support Care Cancer. 2022 May;30(5):4201-4218. doi: 10.1007/s00520-021-06759-9. Epub 2022 Jan 27.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 05781

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