Clinical trial NCT03719716: Early Support in Primary Care for People Starting Treatment for Cancer
Official title: Early Support in Primary Care for People Starting Treatment for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Pancreas
Cancer of Stomach
Cancer of Esophagus
Keywords: Oncology
Palliative Care
Primary care
Care planning
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
Collaborators: name: NHS Fife
First posted: 2018-10-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Health related quality of life: EuroQol EQ-5D-5L
timeFrame: Baseline to 48 weeks or death
Secondary outcomes:
measure: Trial feasibility assessment: conversion rate
timeFrame: Baseline to 48 weeks or death for last recruited participant
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh, NHS Lothian
state: Midlothian
Study officials:
affiliation: The University of Edinburgh/ NHS Lothian
name: Kirsty Boyd, PhD
role: PRINCIPAL_INVESTIGATOR
References: