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Completed

NCT Number: NCT01167179

Nurse-led Follow-up Care for Head and Neck Cancer Patients

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nurse-led consultation

Behavioral

Content of the intervention The intervention consists of structured and standardised nursing follow up consultations comprising a thorough needs assessment, supportive counseling, adequate referral to other care providers if necessary and improvement of the continuity of follow-up care. The goals of nursing follow-up care are summarised as helping patients (and often their partners too) to cope with the physical and psychosocial consequences of treatment and help them to gradually adjust to 'the life after', and into survivorship.

Other names: nurse-led follow-up care

Primary outcomes

  1. Psychosocial Adjustment to Illness-Scale

    Time frame: baseline, 6 mo, 12mo

    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.

Secondary outcomes

  1. Quality of Life

    Time frame: baseline, 6 mo, 12 mo

    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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Nurse-led Follow-up Care for Head and Neck Cancer Patients: a Quasi-experimental Study

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 22, 2010
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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