Clinical trial NCT01167179: Nurse-led Follow-up Care for Head and Neck Cancer Patients
Official title: Nurse-led Follow-up Care for Head and Neck Cancer Patients: a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
nurse-led care
follow-up care
professional-patient relations
psychosocial adjustment
quasi-experimental
prospective
quality of life
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Background: After treatment for cancer, follow-up surveillance is regarded important. In head and neck cancer patients however, increasing research evidence shows that at least the goal of detecting recurrence of cancer during routine control visits in an asymptomatic stage is not achieved. Other goals of follow-up such as management of treatment complications and helping patients and families cope and adjust remain important and ask for an accurate, effective but tailored and sensitive approach. Increasingly, nurses are mentioned as care providers best suited to perform this task.

Aim: 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.

Methods and design: A quasi-experimental prospective design is used. Two groups of patients are enrolled consecutively (n=160) and patient data are collected at baseline (T0), at 6(T1) and at 12(T2) months respectively. The duration of the intervention is defined to the first year of follow up. Participating nurses are trained prior to the recruitment of the intervention group and receive supervision and individual coaching during the entire duration of the intervention phase.

Outcome measures: Primary outcome, psychosocial adjustment to illness. Secondary outcomes, health related quality of life, psychosocial problems, and usage of care.

Eligibility criteria: 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

Primary outcomes:
measure: Psychosocial Adjustment to Illness-Scale
timeFrame: baseline, 6 mo, 12mo
Secondary outcomes:
measure: Quality of Life
timeFrame: baseline, 6 mo, 12 mo
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: T van Achterberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 2012 Aug 4.