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

Rigshospitalet, Denmark93 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Head and Neck Neoplasms

Interventions

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dept. Of Otorhinolaryngology, Head and Neck Surgery and Audiology

Copenhagen, Denmark

Outcomes

Primary Outcomes

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

Time frame: Baseline; 9; 21 and 67 days post-surgery

Secondary Outcomes

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.

Time frame: Baseline, 2, 14 and 60 days post-surgery

Data from ClinicalTrials.gov

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