Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer (EQUIP)
Primary Purpose
Advanced Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
EQUIP
Sponsored by
About this trial
This is an interventional supportive care trial for Advanced Lung Cancer
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
Sites / Locations
- National Cancer Centre Singapore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Quality of life
Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
Quality of life
Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
Quality of life
Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
Psychological distress
Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
Psychological distress
Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
Psychological distress
Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
Secondary Outcome Measures
Number of participants with referral to palliative care services
Number of hospital admissions
Number of visits to the emergency department
Full Information
NCT ID
NCT02801734
First Posted
June 9, 2016
Last Updated
March 28, 2018
Sponsor
National Cancer Centre, Singapore
Collaborators
Duke-NUS Graduate Medical School
1. Study Identification
Unique Protocol Identification Number
NCT02801734
Brief Title
Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
Acronym
EQUIP
Official Title
Pilot Trial of the Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
January 20, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore
Collaborators
Duke-NUS Graduate Medical School
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Lung Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
EQUIP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life
Description
Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
Time Frame
4 weeks
Title
Quality of life
Description
Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
Time Frame
8 weeks
Title
Quality of life
Description
Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
Time Frame
12 weeks
Title
Psychological distress
Description
Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
Time Frame
4 weeks
Title
Psychological distress
Description
Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
Time Frame
8 weeks
Title
Psychological distress
Description
Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of participants with referral to palliative care services
Time Frame
6 months
Title
Number of hospital admissions
Time Frame
6 months
Title
Number of visits to the emergency department
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Overall survival
Time Frame
1 year
Title
Number of participants who died at home
Time Frame
1 year
Title
Number of participants with anti-cancer therapy in the last 4 weeks of life
Time Frame
Last four weeks of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
12. IPD Sharing Statement
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Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
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