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

Not Applicable

Completed

• Conditions: Advanced Lung Cancer
• Interventions: Other: EQUIP

• Registration Number: NCT02801734
• Lead Sponsor: National Cancer Centre, Singapore

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-16
• Study Start: 2016-08-01
• Primary Completion: 2017-01-20
• Study Completion: 2017-12-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	EQUIP	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.

Primary Outcome Measures

Name	Time	Method
Quality of life	12 weeks	Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
Psychological distress	12 weeks	Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).

Secondary Outcome Measures

Name	Time	Method
Number of visits to the emergency department	6 months
Number of participants with referral to palliative care services	6 months
Number of hospital admissions	6 months

Trial Locations

Locations (1)

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore