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

Advanced Lung Cancer Clinical Trial

— EQUIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801734
• Other study ID #: NCCSPG-YR2016-JAN-15
• Status: Completed
• Phase: N/A
• First received: June 9, 2016
• Last updated: March 28, 2018
• Start date: August 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: National Cancer Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 31, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Lung Cancer
• Lung Neoplasms

Intervention

Other:
• EQUIP
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.

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	Duke-NUS Graduate Medical School

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival		1 year
Other	Number of participants who died at home		1 year
Other	Number of participants with anti-cancer therapy in the last 4 weeks of life		Last four weeks of life
Primary	Quality of life	Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.	4 weeks
Primary	Quality of life	Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.	8 weeks
Primary	Quality of life	Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.	12 weeks
Primary	Psychological distress	Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).	4 weeks
Primary	Psychological distress	Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).	8 weeks
Primary	Psychological distress	Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).	12 weeks
Secondary	Number of participants with referral to palliative care services		6 months
Secondary	Number of hospital admissions		6 months
Secondary	Number of visits to the emergency department		6 months