Head and Neck Neoplasms
Conditions
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.
Interventions
OTHERNeeds assesment tool integrated in nursing consultation.
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
Sponsors
Novo Nordisk A/S
Danish Nurses Organisation
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Outcome results
None listed