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

NCT02801734 | Completed

• 1 other identifier: NCCSPG-YR2016-JAN-15
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Lung Cancer

Outcome Measures

Primary Outcomes (6)

• Quality of life

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

  4 weeks

• Quality of life

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

  8 weeks

• Quality of life

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

  12 weeks

• Psychological distress

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

  4 weeks

• Psychological distress

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

  8 weeks

• Psychological distress

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

  12 weeks

Secondary Outcomes (3)

• Number of participants with referral to palliative care services

  6 months

• Number of hospital admissions

  6 months

• Number of visits to the emergency department

  6 months

Other Outcomes (3)

• Overall survival

  1 year

• Number of participants who died at home

  1 year

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

  Last four weeks of life

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has stage 3 or 4 lung cancer
• ECOG 0,1 or 2
• Able and willing to participate in the EQUIP programme

You may not qualify if:

• \- Unable to communicate in English or Mandarin

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 16, 2016
• Study Start: August 1, 2016
• Primary Completion: January 20, 2017
• Study Completion: December 31, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

SG (1)