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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Radboud University.
Recruitment status was  Active, not recruiting
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

July 19, 2010
November 24, 2011
December 2008
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01167179 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Nurse-led Follow-up Care for Head and Neck Cancer Patients
An Early Evaluation Study Testing 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.

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: 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.
    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01167179
JDL-001-TVA
No
Jacqueline de Leeuw, Radboud University
Radboud University
Not Provided
Principal Investigator: T van Achterberg, PhD Radboud University
Radboud University
November 2011

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