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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Nijmegen, Nederland, 6500 HB
- Radboud University Nijmegen Medical Centre
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: 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.
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Eksperimentell: 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. |
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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Psychosocial Adjustment to Illness-Scale
Tidsramme: baseline, 6 mo, 12mo
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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.
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baseline, 6 mo, 12mo
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Quality of Life
Tidsramme: baseline, 6 mo, 12 mo
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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.
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baseline, 6 mo, 12 mo
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: T van Achterberg, PhD, Radboud University Medical Center
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
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Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- JDL-001-TVA
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