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NCT Number: NCT02801734

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

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.

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Key information

Conditions

Advanced Lung Cancer

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre Singapore

Singapore, 169610

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EQUIP

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.

Primary outcomes

  1. Quality of life

    Time frame: 4 weeks

    Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.

  2. Quality of life

    Time frame: 8 weeks

    Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.

  3. Quality of life

    Time frame: 12 weeks

    Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.

  4. Psychological distress

    Time frame: 4 weeks

    Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).

  5. Psychological distress

    Time frame: 8 weeks

    Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).

  6. Psychological distress

    Time frame: 12 weeks

    Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).

Secondary outcomes

  1. Number of participants with referral to palliative care services

    Time frame: 6 months

  2. Number of hospital admissions

    Time frame: 6 months

  3. Number of visits to the emergency department

    Time frame: 6 months

Other outcomes

  1. Overall survival

    Time frame: 1 year

  2. Number of participants who died at home

    Time frame: 1 year

  3. Number of participants with anti-cancer therapy in the last 4 weeks of life

    Time frame: Last four weeks of life

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Collaborators

  • Duke-NUS Graduate Medical School

Registry information

Official study title

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

Acronym: EQUIP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2016
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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