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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801734
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
National Cancer Centre, Singapore

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.


Condition or disease Intervention/treatment Phase
Advanced Lung Cancer Other: EQUIP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pilot Trial of the Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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.

No Intervention: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801734


Locations
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Singapore
National Cancer Centre Singapore
Singapore, Singapore, 169610
Sponsors and Collaborators
National Cancer Centre, Singapore
Duke-NUS Graduate Medical School
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Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT02801734    
Other Study ID Numbers: NCCSPG-YR2016-JAN-15
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases