Cancer of PancreasGI-ACPNCT03719716
Early Support in Primary Care for People Starting Treatment for Cancer
A study testing Anticipatory care planning letter in people with Cancer of Pancreas and Cancer of Stomach, run by NHS Lothian at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Pancreas, Cancer of Stomach, Cancer of Esophagus
- What is being tested?
- Anticipatory care planning letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with advanced, inoperable oesophageal, gastric or pancreatic cancers
- People being offered palliative chemotherapy and/or radiotherapy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh, NHS Lothian
Edinburgh, Midlothian, EH164SA
About this study
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.
Read the 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.
- Conditions
- Cancer of Pancreas, Cancer of Stomach, Cancer of Esophagus
- Being tested
- Anticipatory care planning letter
- Keywords
- Oncology, Palliative Care, Primary care, Care planning
- Medical subject headings
- Pancreatic Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticipatory care planning letterOther
Patient letter to take to GP and GP literature
| Study group | Role | What they receive |
|---|---|---|
| Early support group | Experimental | 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. Receives: Other: Anticipatory care planning letter |
| Usual care group | No intervention | No change to standard care from oncology services and primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 48 weeks or death
Secondary outcomes (1)
Trial feasibility assessment: conversion rate
Screening to consent conversion rate
Measured: Baseline to 48 weeks or death for last recruited participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Jan 2019
- Primary completion31 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Collaborators
- NHS Fife
- Responsible party
- Sponsor
- Investigators
- Kirsty Boyd, PhD, Principal investigator, The University of Edinburgh/ NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719716
- Sponsor's protocol ID
- AC18066
- Acronym
- GI-ACP
- Status last verified
- Jan 2021
- First submitted
- 17 Sep 2018
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All non-person identifiable data will be collected and stored to allow it to be archived and shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Support in Primary Care for People Starting Treatment for Cancer
- ClinicalTrials.gov ID
- NCT03719716
- Acronym / sponsor ID
- GI-ACP / AC18066
- Conditions
- Cancer of Pancreas, Cancer of Stomach, Cancer of Esophagus
- Keywords
- Oncology, Palliative Care, Primary care, Care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Collaborators
- NHS Fife
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Feasibility randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Early support group | Experimental | Other: Anticipatory care planning letterThis 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. |
| Usual care group | No intervention | –No change to standard care from oncology services and primary care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People with advanced, inoperable oesophageal, gastric or pancreatic cancers
- People being offered palliative chemotherapy and/or radiotherapy
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticipatory care planning letterPatient letter to take to GP and GP literature | Other | Early support group |
Primary outcome
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
1 secondary outcome
Trial feasibility assessment: conversion rate
Time frame: Baseline to 48 weeks or death for last recruited participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: Yes. All non-person identifiable data will be collected and stored to allow it to be archived and shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty Boyd, PhD principal investigator
The University of Edinburgh/ NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticipatory care planning letter in people with Cancer of Pancreas and Cancer of Stomach, run by NHS Lothian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life: EuroQol EQ-5D-5L (time frame: Baseline to 48 weeks or death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.