Clinical Trials Directory

Trials / Completed

CompletedNCT02801734

Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer

Pilot Trial of the Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
69 (actual)
Sponsor
National Cancer Centre, Singapore · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHEREQUIPPatients 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.

Timeline

Start date
2016-08-01
Primary completion
2017-01-20
Completion
2017-12-31
First posted
2016-06-16
Last updated
2018-03-29

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT02801734. Inclusion in this directory is not an endorsement.