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

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Needs assesment tool integrated in nursing consultation.
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Neoplasms

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group (IG)

Control Group (CG)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 31, 2018
Last Updated
October 8, 2020
Sponsor
Rigshospitalet, Denmark
Collaborators
Novo Nordisk A/S, Danish Nurses Organisation
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1. Study Identification

Unique Protocol Identification Number
NCT03443258
Brief Title
Needs Assessment Tool Integrated in Clinical Practice of Head and Neck Cancer Rehabilitation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Novo Nordisk A/S, Danish Nurses Organisation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are assigned to either intervention or control group. The intervention group receives a nursing consultation using a need assessment and decision making tool. The control group receives usual care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group (IG)
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group (CG)
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Needs assesment tool integrated in nursing consultation.
Intervention Description
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 Outcome Measure Information:
Title
Change in Health Related Quality of Life, from baseline to 9, 21 and until 67 days post surgery
Description
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
Time Frame
Baseline; 9; 21 and 67 days post-surgery
Secondary Outcome Measure Information:
Title
Change in Symptom Burden from baseline to 2, 14 and 60 days post-surgery
Description
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.
Time Frame
Baseline, 2, 14 and 60 days post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annelise Mortensen, MSA
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Of Otorhinolaryngology, Head and Neck Surgery and Audiology
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35083545
Citation
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.
Results Reference
derived

Learn more about this trial

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

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