Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer (EQUIP)
Pilot Trial of the Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
i. Project Background Patients with advanced lung cancer have a high symptom burden and low quality of life. Early palliative care improves patient outcomes in newly diagnosed advanced lung cancer patients, but previously tested models are not feasible for widespread adoption. Hence, the aim of this study is to pilot a more sustainable nurse-led intervention - Enhancing Quality of life in Patients (EQUIP).
ii. Hypothesis / Aim The aims of this study are three-fold. Firstly, the investigators aim to determine the feasibility and acceptability of the EQUIP intervention itself. Secondly, the investigators aim to obtain a tentative estimate of efficacy of the EQUIP intervention. Thirdly, the investigators aim to determine the data completion rate of patient reported outcome measures in the context of the EQUIP trial.
iii. Methods Patients with newly diagnosed stage 3 or stage 4 lung cancer will be recruited and randomized to the EQUIP intervention or usual care (control) group. Patients randomized to the EQUIP intervention group will receive four face-to-face sessions with a palliative care nurse. The content of these educational sessions will equip patients with the knowledge and skills to manage the three commonest symptoms of fatigue, breathlessness and anxiety.
All participants will complete the Functional Assessment of Cancer Therapy - Lung (FACT-L), the Hospital Anxiety and Depression Scale (HADS) and the stigma subscale at four time points: baseline, 4, 8 and 12 weeks after recruitment. Measures of healthcare use will also be recorded. Additionally, participants in the intervention group will complete a feedback survey after each intervention session.
A total sample of 60 patients (30 in each arm) will be recruited.
Clinical Significance
If successful, this study will lead to a larger scale phase III trial which tests various components of the EQUIP intervention, in order to develop a sustainable and effective model for the provision of palliative care to advanced lung cancer patients.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Singapore, Singapore, 169610
- National Cancer Centre Singapore
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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
- Has stage 3 or 4 lung cancer
- ECOG 0,1 or 2
- Able and willing to participate in the EQUIP programme
Exclusion criteria
- Unable to communicate in English or Mandarin
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervention
Participants in the EQUIP intervention group will individually receive four face-to-face sessions with a palliative care nurse. For all participants, whether in intervention or control, usual care is provided - the primary oncologist may make a referral for palliative care input if deemed appropriate. |
Patients in the EQUIP intervention group will receive four face-to-face sessions.
The focus of these sessions is to equip patients with the skills and strategies needed to cope with common symptoms experienced by lung cancer patients.
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Ingen inngripen: Control
For all participants, whether in intervention or control, usual care is provided - the primary oncologist may make a referral for palliative care input if deemed appropriate.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Quality of life
Tidsramme: 4 weeks
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Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
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4 weeks
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Quality of life
Tidsramme: 8 weeks
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Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
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8 weeks
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Quality of life
Tidsramme: 12 weeks
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Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
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12 weeks
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Psychological distress
Tidsramme: 4 weeks
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Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
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4 weeks
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Psychological distress
Tidsramme: 8 weeks
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Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
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8 weeks
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Psychological distress
Tidsramme: 12 weeks
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Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
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12 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Number of participants with referral to palliative care services
Tidsramme: 6 months
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6 months
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Number of hospital admissions
Tidsramme: 6 months
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6 months
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Number of visits to the emergency department
Tidsramme: 6 months
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6 months
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Andre resultatmål
Resultatmål |
Tidsramme |
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Total overlevelse
Tidsramme: 1 år
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1 år
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Number of participants who died at home
Tidsramme: 1 year
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1 year
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Number of participants with anti-cancer therapy in the last 4 weeks of life
Tidsramme: Last four weeks of life
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Last four weeks of life
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCCSPG-YR2016-JAN-15
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