Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatment nurse-led consultation
Sponsor Radboud University
Start date December 2008
End date May 2012
Trial size 160 participants
Trial identifier NCT01167179, JDL-001-TVA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(No Intervention)
Usual care Participants in the comparison group receive the usual care which consists of a 5 year medical routine control schedule based on the national guidelines, and - if appropriate - involvement of the dietician and the speech language therapist.During years one to five the routine control appointments are planned at a minimum of every 2, 3, 4, 6 and 12 months respectively. Most patients who undergo a total laryngectomy have additional contact with an oncology nurse during their 6-8 weekly medical control visits at the outpatient clinic for approximately the first year of follow-up. All other head and neck cancer patients have no structured follow-up contact with an oncology nurse.
nurse-led consultation nurse-led follow-up care
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.
(Experimental)
Interventional care During the first year of follow-up every 2-monthly medical control visit is preceded or followed by a nursing consultation of 30 minutes for all included patients in the intervention group. No restrictions are made with regard to cancer stage, site or treatment modality. Thus, at least 6 nursing consultations are planned in this way but nurses are allowed to plan extra nursing consultations if necessary. Content of 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.
nurse-led consultation nurse-led follow-up care
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.

Primary Outcomes

Measure
Psychosocial adjustment to Illness
time frame: one year

Secondary Outcomes

Measure
Quality of life
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Early Evaluation Study Testing Nurse-led Follow-up Care for Head and Neck Cancer Patients
Principal investigator T van Achterberg, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Radboud University.