NCT03719716

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 9, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

September 17, 2018

Last Update Submit

March 8, 2021

Conditions

Cancer of PancreasCancer of StomachCancer of Esophagus

Keywords

OncologyPalliative CarePrimary careCare planning

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life: EuroQol EQ-5D-5L

    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 Outcomes (1)

  • Trial feasibility assessment: conversion rate

    Baseline to 48 weeks or death for last recruited participant

Study Arms (2)

Early support group

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

No change to standard care from oncology services and primary care

Interventions

Anticipatory care planning letterOTHER

Patient letter to take to GP and GP literature

Early support group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh, NHS Lothian

Edinburgh, Midlothian, EH164SA, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsStomach NeoplasmsEsophageal NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Study Officials

  • Kirsty Boyd, PhD

    The University of Edinburgh/ NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be randomised automatically by the local trials unit and allocated a study number. This will be used in all statistical analyses and other quantitative data analysis including the questionnaires. The study researcher will know the identity of the participants she interviews and the qualitative analysis cannot be blinded although all data generated will be anonymised.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Feasibility randomised controlled trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

October 25, 2018

Study Start

January 1, 2019

Primary Completion

August 31, 2020

Study Completion

December 31, 2020

Last Updated

March 9, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Up to 10 years post study
Access Criteria
During study data will not be shared just the supporting information. After study storage will be arranged by The University of Edinburgh

Locations

GB(1)