Needs Assessment Tool Integrated in Clinical Practice of Head and Neck Cancer Rehabilitation
- Conditions
- Head and Neck Neoplasms
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- Clinical diagnosis of Head and Neck Cancer
- Stage T3 or T4
- Surgically treated
- Must be able to speak and understand Danish
- 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
- 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
Dept. Of Otorhinolaryngology, Head and Neck Surgery and Audiology🇩🇰Copenhagen, Denmark