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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03719716
Recruitment Status : Completed
First Posted : October 25, 2018
Last Update Posted : March 9, 2021
Sponsor:
Collaborator:
NHS Fife
Information provided by (Responsible Party):
NHS Lothian

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer of Pancreas Cancer of Stomach Cancer of Esophagus Other: Anticipatory care planning letter Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Feasibility randomised controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Early Support in Primary Care for People Starting Treatment for Cancer
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : December 31, 2020

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Trial feasibility assessment: conversion rate [ Time Frame: Baseline to 48 weeks or death for last recruited participant ]
    Screening to consent conversion rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719716


Locations
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United Kingdom
Royal Infirmary of Edinburgh, NHS Lothian
Edinburgh, Midlothian, United Kingdom, EH164SA
Sponsors and Collaborators
NHS Lothian
NHS Fife
Investigators
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Principal Investigator: Kirsty Boyd, PhD The University of Edinburgh/ NHS Lothian
More Information
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Responsible Party: NHS Lothian
ClinicalTrials.gov Identifier: NCT03719716    
Other Study ID Numbers: AC18066
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All non-person identifiable data will be collected and stored to allow it to be archived and shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NHS Lothian:
Oncology
Palliative Care
Primary care
Care planning
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
 Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases