Skip to main content
OpenTrials
Completed

NCT Number: NCT03719716

Early Support in Primary Care for People Starting Treatment for Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer of Pancreas Cancer of Esophagus Cancer of Stomach Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Infirmary of Edinburgh, NHS Lothian

Edinburgh, Midlothian, EH164SA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anticipatory care planning letter

Other

Patient letter to take to GP and GP literature

Primary outcomes

  1. 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

Secondary outcomes

  1. Trial feasibility assessment: conversion rate

    Time frame: Baseline to 48 weeks or death for last recruited participant

    Screening to consent conversion rate

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Collaborators

  • NHS Fife

Registry information

Acronym: GI-ACP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2018
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.