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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Jacqueline de Leeuw, Radboud University

ClinicalTrials.gov Identifier:

NCT01167179

First received: July 19, 2010

Last updated: November 24, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2010

Last Updated Date

November 24, 2011

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Psychosocial adjustment to Illness [ Time Frame: one year ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01167179 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]

Generally, quality of life refers to a broad spectrum of issues, including physical, social, cognitive, spiritual, emotional and role functioning, as well as psychological symptomatology and symptoms such as pain, nausea and fatigue.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

Behavioral: nurse-led consultation

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 Name: nurse-led follow-up care

Study Arm (s)

No Intervention: comparison group
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.

Intervention: Behavioral: nurse-led consultation
Experimental: intervention group
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.

Intervention: Behavioral: nurse-led consultation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

May 2012

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01167179

Other Study ID Numbers ^ICMJE

JDL-001-TVA

Has Data Monitoring Committee

Responsible Party

Jacqueline de Leeuw, Radboud University

Study Sponsor ^ICMJE

Radboud University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

T van Achterberg, PhD

Radboud University

Information Provided By

Radboud University

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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