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

NCT01167179 | Completed Results

• 1 other identifier: JDL-001-TVA
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; nurse-led care; follow-up care; professional-patient relations; psychosocial adjustment; quasi-experimental; prospective; quality of life

Outcome Measures

Primary Outcomes (1)

• Psychosocial Adjustment to Illness-Scale

  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.

  baseline, 6 mo, 12mo

Secondary Outcomes (1)

• Quality of Life

  baseline, 6 mo, 12 mo

Study Arms (2)

comparison group

NO INTERVENTION

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

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.

Behavioral: nurse-led consultation

Interventions

nurse-led consultation BEHAVIORAL

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.

Also known as: nurse-led follow-up care

nurse-led consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Actual psychiatric disease
• Actual alcohol addiction
• Known life expectancy of \< 6 months

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 22864472 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Limitations and Caveats

A historical control group being the comparison group was the 'usual care' group that included participants who were enrolled during the study and received usual care, as described. Lack of randomization may have been a confounding factor.

Results Point of Contact

• Title: Jacqueline de Leeuw MSc
• Organization: Radboud University Nijmegen Medical Center

j.deleeuw@kno.umcn.nl

+31243614925

Study Officials

• T van Achterberg, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 22, 2010
• Study Start: December 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 15, 2017
• Results First Posted: December 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)