Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
NCT ID: NCT02801734
Last Updated: 2018-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2016-08-01
2017-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention
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.
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.
Control
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ECOG 0,1 or 2
* Able and willing to participate in the EQUIP programme
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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Duke-NUS Graduate Medical School
OTHER
National Cancer Centre, Singapore
OTHER
Responsible Party
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Locations
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National Cancer Centre Singapore
Singapore, , Singapore
Countries
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Other Identifiers
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NCCSPG-YR2016-JAN-15
Identifier Type: -
Identifier Source: org_study_id
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