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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Neoplasms
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Change in Health Related Quality of Life, from baseline to 9, 21 and until 67 days post surgery
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Annelise Mortensen
PhD student
Rigshospitalet, Denmark
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.
Outcomes
Primary Outcomes
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
- Change in Symptom Burden from baseline to 2, 14 and 60 days post-surgery(Baseline, 2, 14 and 60 days post-surgery)