Clinical trial NCT02801734: Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
Official title: Pilot Trial of the Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Lung Cancer
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Duke-NUS Graduate Medical School
First posted: 2016-06-16
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
timeFrame: 4 weeks
measure: Quality of life
timeFrame: 8 weeks
measure: Quality of life
timeFrame: 12 weeks
measure: Psychological distress
timeFrame: 4 weeks
measure: Psychological distress
timeFrame: 8 weeks
measure: Psychological distress
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of participants with referral to palliative care services
timeFrame: 6 months
measure: Number of hospital admissions
timeFrame: 6 months
measure: Number of visits to the emergency department
timeFrame: 6 months
Other outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Number of participants who died at home
timeFrame: 1 year
measure: Number of participants with anti-cancer therapy in the last 4 weeks of life
timeFrame: Last four weeks of life
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
References: