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An Early Evaluation Study Testing Nurse-led Follow-up Care for Head and Neck Cancer Patients

18 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

An Early Evaluation Study Testing Nurse-led Follow-up Care for Head and Neck Cancer Patients

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Psychosocial adjustment to Illness

Outcome Description:

Psychosocial adjustment can be viewed as an outcome of coping strategies used by patients to deal with the distress and aftermath of treatment and illness.

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

T van Achterberg, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

December 2008

Completion Date:

May 2012

Related Keywords:

  • Head and Neck Cancer
  • head and neck cancer
  • nurse-led care
  • follow-up care
  • professional-patient relations
  • psychosocial adjustment
  • quasi-experimental
  • prospective
  • quality of life
  • Head and Neck Neoplasms