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

NCT ID: NCT02801734

Last Updated: 2018-03-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Advanced Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

EQUIP

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke-NUS Graduate Medical School

OTHER

Sponsor Role collaborator

National Cancer Centre, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cancer Centre Singapore

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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NCCSPG-YR2016-JAN-15

Identifier Type: -

Identifier Source: org_study_id

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