Head and Neck Cancer Clinical Trial
Official title:
Nurse-led Follow-up Care for Head and Neck Cancer Patients: a Quasi-experimental Study
Verified date | May 2017 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to conduct an early evaluation of a nurse-led follow up intervention added to the usual medically oriented follow up care. Besides evaluating the feasibility and acceptability to patients, the effect on psychosocial adjustment and quality of life of patients is determined.
Status | Completed |
Enrollment | 160 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosed with a primary head and neck tumour - Absence of other cancers diagnosed - Treatment with curative intent, all treatment modalities - Treatment and 12 month follow-up planned in Radboud University Nijmegen Medical Centre - Able to speak, write and understand Dutch - Cognitively able to give informed consent Exclusion Criteria: - Actual psychiatric disease - Actual alcohol addiction - Known life expectancy of < 6 months |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud University Nijmegen Medical Centre | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
de Leeuw J, Prins JB, Teerenstra S, Merkx MA, Marres HA, van Achterberg T. Nurse-led follow-up care for head and neck cancer patients: a quasi-experimental prospective trial. Support Care Cancer. 2013 Feb;21(2):537-47. doi: 10.1007/s00520-012-1553-1. Epub — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psychosocial Adjustment to Illness-Scale | The adaptive psychosocial response of an individual to a significant life change was assessed using the Psychosocial Adjustment to Illness Scale -Self Report (PAIS-SR), a 46-item self-report measure that assesses changes in seven domains. A mean PAIS-SR T-score of 50 is the average score for each domain, meaning that patients with this score adjusted neither better nor worse than a mixed cancer reference group, whereas a score lower than 50 indicates better adjustment. The total scale range for the T score is 21-80. The PAIS-SR is well validated and has been used in previous studies of HNC patients.Here, we used the validated Dutch translation. | baseline, 6 mo, 12mo | |
Secondary | Quality of Life | Quality of Life(QoL)was measured with the EORTC QLQ-C30 and QLQ-H&N35.The EORTC QLQ-C30 contains five functioning scales, a global health status/QoL scale, and nine symptom scales. The QLQ-H&N35 contains 18 disease-specific symptom scales. All scores in both the EORTC QLQ-C30 and QLQ-H&N35 were transformed to a 0-100 scale following instructions in the scoring manual, with higher scores representing better quality of life and less disease-specific symptoms. | baseline, 6 mo, 12 mo |
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