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

Radboud University Medical Center

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Behavioral: nurse-led consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT01167179

JDL-001-TVA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

comparison group

No Intervention group

Description:

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

Experimental group

Description:

Interventional care Year 1 follow-up: 2-monthly medical control visit + 30 minute nursing consultation, to a minimum of 6 in year 1. No restrictions with regard to cancer stage, site or treatment modality. Intervention consist of standardised nursing 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. Goals: helping patients (and their partners) cope with the physical and psychosocial consequences of treatment and help them to gradually adjust to 'the life after', and into survivorship.

Treatment:

Behavioral: nurse-led consultation