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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167179
First Posted: July 22, 2010
Last Update Posted: December 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jacqueline de Leeuw, Radboud University
July 19, 2010
July 22, 2010
December 6, 2012
December 15, 2017
December 15, 2017
December 2008
May 2012   (Final data collection date for primary outcome measure)
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.
Psychosocial adjustment to Illness [ Time Frame: one year ]
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.
Complete list of historical versions of study NCT01167179 on ClinicalTrials.gov Archive Site
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.
Quality of Life [ Time Frame: one year ]
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.
Not Provided
Not Provided
 
Nurse-led Follow-up Care for Head and Neck Cancer Patients
Nurse-led Follow-up Care for Head and Neck Cancer Patients: a Quasi-experimental Study
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Head and Neck Cancer
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
  • 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.
  • Experimental: nurse-led consultation

    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.

    Intervention: Behavioral: nurse-led consultation
de Leeuw J, Prins JB, Teerenstra S, Merkx MA, Marres HA, van Achterberg T. Nurse-led follow-up care for head and neck cancer patients: a quasi-experimental prospective trial. Support Care Cancer. 2013 Feb;21(2):537-47. doi: 10.1007/s00520-012-1553-1. Epub 2012 Aug 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
May 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01167179
JDL-001-TVA
No
Not Provided
Plan to Share IPD: No
Jacqueline de Leeuw, Radboud University
Radboud University
Not Provided
Principal Investigator: T van Achterberg, PhD Radboud University
Radboud University
May 2017

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