Early Support in Primary Care for People Starting Treatment for Cancer (GI-ACP)

March 8, 2021 updated by: NHS Lothian
This is a feasibility, randomised controlled trial (RCT) of a person-centred care planning intervention involving patients recently diagnosed with a poor prognosis cancer who are starting a palliative oncology treatment in a Scottish regional cancer centre.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the feasibility and acceptability of an early 'palliative care' intervention consisting of anticipatory care planning coordinated in primary care that is systematically triggered when patients with poor prognosis gastrointestinal cancers start palliative oncology treatment.

Patients will be identified and invited to participate during their assessment and treatment planning by the cancer care clinicians. A screening log will record eligible cases. Patients who consent will be randomised to receive a letter about the benefits of early anticipatory care planning to take to their preferred general practitioner to help trigger earlier support by their primary care team. Control patients receive usual care. All study patients will be asked to complete 3 questionnaires (EuroQol EQ-5D-5L (full title of tool), ICECAP Supportive Care Measure (full title of tool), and CollaboRATE (full title of tool) for shared decision-making) at baseline, 6, 12, 24 and 48 weeks. A purposive sub-sample of patients, family carer and general practitioner (GP) triads will be invited for interview at around 6 and 20 weeks to explore their experiences of trial participation, their illness and care. Health service use will be recorded including hospital admissions, oncology treatment, palliative care referral, time and place of death or survivorship.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH164SA
        • Royal Infirmary of Edinburgh, NHS Lothian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • People with advanced, inoperable oesophageal, gastric or pancreatic cancers
  • People being offered palliative chemotherapy and/or radiotherapy

Exclusion Criteria:

  • People too ill to participate or give informed consent.
  • Patient who are not fit for oncology treatment or who opt for best supportive care.
  • People with other life-limiting conditions likely to cause death within 6 months.
  • People with moderate to severe cognitive impairment that precludes completions of questionnaires or participation in interviews.
  • People unable to give informed consent or communicate by telephone with the researcher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early support group
This group receive the Anticipatory care planning letter to take to their GP and the GP receives a copy of the Scottish Anticipatory Care Planning information leaflet and a short communication guide about ACP.
Other: Anticipatory care planning letter
Patient letter to take to GP and GP literature
NO_INTERVENTION: Usual care group
No change to standard care from oncology services and primary care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life: EuroQol EQ-5D-5L
Time Frame: Baseline to 48 weeks or death

Health related quality of life assessed using the EuroQol EQ-5D-5L.

The EQ-5D-5L has 2 components:

There is a descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.

The EQ VAS (visual analogue scale) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.

The users guide gives details of the scoring system: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-5L_UserGuide_2015.pdf
Baseline to 48 weeks or death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trial feasibility assessment: conversion rate
Time Frame: Baseline to 48 weeks or death for last recruited participant
Screening to consent conversion rate
Baseline to 48 weeks or death for last recruited participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Lothian

Collaborators

NHS Fife

Investigators

  • Principal Investigator: Kirsty Boyd, PhD, The University of Edinburgh/ NHS Lothian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

August 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (ACTUAL)

October 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC18066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All non-person identifiable data will be collected and stored to allow it to be archived and shared

IPD Sharing Time Frame

Up to 10 years post study

IPD Sharing Access Criteria

During study data will not be shared just the supporting information. After study storage will be arranged by The University of Edinburgh

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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