NCT02559336

Brief Summary

Advanced cancer patients have a poor quality of life and a high rate of unplanned hospital admissions. Palliative care has been shown to improve patient outcomes such as quality of life and symptom burden. Our long-term aim is to study the effect of Supportive and Palliative Care Review Kit (SPaRK) - a novel model of early palliative care in the acute hospital inpatient setting. To this end, we propose a pilot study that will provide the necessary information for the planning of a subsequent larger scale Phase III trial of SPaRK. The specific aims of this pilot study are: 1) to estimate the recruitment rate and ability of advanced cancer patients to complete the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which measures health-related quality of life (QOL) in the four domains of physical well-being, social/family well-being, emotional well-being, and functional well-being, 2) to obtain a tentative estimate of the effect size of the SPaRK model of care on change in patient QOL over 6 days, 3) to explore the responsiveness to change of FACT-G over 3 days and 4) to explore views of healthcare professionals and stakeholders on SPaRK as a model of integrated palliative care and oncology care service delivery. In the short term, the results from this study will be used to plan a larger scale Phase III study of SPaRK. In the long term, a resource-efficient and effective model of care needs to be developed for the aging population and rising palliative care needs of patients. If successful, this pilot study will lead on to the testing of SPaRK, which does not rely wholly on specialist palliative care manpower, but involves both specialists and non-specialists working together to provide palliative care, and hence can be feasibly scaled up across institutions and extended to non-cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
865

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 22, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

September 22, 2015

Last Update Submit

January 7, 2018

Conditions

Cancer

Keywords

Palliative CareCancerHealth Services Research

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Functional Assessment of Cancer Therapy - General (FACT-G)

    6 days

Study Arms (2)

Control

NO INTERVENTION

Usual care: Oncology team refers patients to palliative care team if deemed appropriate

Intervention

EXPERIMENTAL

Integrated oncology care and palliative care

Other: Integrated palliative oncology care

Interventions

Integrated palliative oncology careOTHER

Integrated palliative care and oncology care for advanced cancer patients who have an unplanned admission to hospital

Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has an unplanned admission to SGH under the care of the inpatient DMO Lung team
  • Has a cancer diagnosis of stage 4 solid tumor
  • Has capacity to give written informed consent to participate in the study (for patients who complete the patient questionnaires)

You may not qualify if:

  • Unable to complete self-administration of the FACT-G questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Grace M Yang, MRCP

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 24, 2015

Study Start

November 22, 2015

Primary Completion

November 30, 2016

Study Completion

September 30, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

SG(1)