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

Not Applicable

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Other: Needs assesment tool integrated in nursing consultation.

• Registration Number: NCT03443258
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-23
• Study Start: 2018-06-11
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-10-08
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group (IG)	Needs assesment tool integrated in nursing consultation.	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

Primary Outcome Measures

Name	Time	Method
Change in Health Related Quality of Life, from baseline to 9, 21 and until 67 days post surgery	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 Outcome Measures

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

Trial Locations

Locations (1)

Dept. Of Otorhinolaryngology, Head and Neck Surgery and Audiology; 🇩🇰 Copenhagen, Denmark