Early Support in Primary Care for People Starting Treatment for Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Cancer of Pancreas Cancer of Stomach Cancer of Esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Feasibility randomised controlled trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Early support group

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.

Group Type EXPERIMENTAL

Anticipatory care planning letter

Intervention Type OTHER

Patient letter to take to GP and GP literature

Usual care group

No change to standard care from oncology services and primary care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Anticipatory care planning letter

Patient letter to take to GP and GP literature

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No