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
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Behavioral: nurse-led consultation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: An Early Evaluation Study Testing Nurse-led Follow-up Care for Head and Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 160
Study Start Date: December 2008
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167179

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: T van Achterberg, PhD Radboud University
  More Information

No publications provided

Responsible Party: Jacqueline de Leeuw, MSc, Radboud University
ClinicalTrials.gov Identifier: NCT01167179     History of Changes
Other Study ID Numbers: JDL-001-TVA
Study First Received: July 19, 2010
Last Updated: November 24, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
head and neck cancer
nurse-led care
follow-up care
professional-patient relations
psychosocial adjustment
quasi-experimental
prospective
quality of life

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on August 21, 2014