Cancer of Esophagus, Cancer of Pancreas, Cancer of Stomach
Conditions
Keywords
Oncology, Palliative Care, Primary care, Care planning
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.
Interventions
OTHERAnticipatory care planning letter
Patient letter to take to GP and GP literature
Sponsors
NHS Fife
NHS Lothian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, 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.
Intervention model description
Feasibility randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life: EuroQol EQ-5D-5L | 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
| Measure | Time frame | Description |
|---|---|---|
| Trial feasibility assessment: conversion rate | Baseline to 48 weeks or death for last recruited participant | Screening to consent conversion rate |
Countries
United Kingdom
Outcome results
None listed