Early Support in Primary Care for People Starting Treatment for Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Support in Primary Care for People Starting Treatment for Cancer

Conditions
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Cancer of Pancreas, Cancer of Stomach, Cancer of Esophagus

Intervention / Treatment
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* Other: Anticipatory care planning letter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Feasibility randomised controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early support group<br>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<br>* Patient letter to take to GP and GP literature<br>|
| No Intervention: Usual care group<br>No change to standard care from oncology services and primary care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncology, Palliative Care, Primary care, Care planning