Early Support in Primary Care for People Starting Treatment for Cancer

Cancer of Pancreas Clinical Trial

— GI-ACP  

Official title:

Early Support in Primary Care for People Starting Treatment for Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719716
• Other study ID #: AC18066
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: NHS Lothian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Esophagus
• Cancer of Pancreas
• Cancer of Stomach
• Esophageal Neoplasms
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Other:
• Anticipatory care planning letter
Patient letter to take to GP and GP literature

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh, NHS Lothian	Edinburgh	Midlothian

Sponsors (2)

Lead Sponsor	Collaborator
NHS Lothian	NHS Fife

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Trial feasibility assessment: conversion rate	Screening to consent conversion rate	Baseline to 48 weeks or death for last recruited participant