Condition category
Cancer
Date applied
27/10/2020
Date assigned
30/11/2020
Last edited
30/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The introduction of oral medications to treat cancer is a new and welcome development in cancer management. These are called oral anticancer medications (OAM) and are an attractive option for patients. OAMs are being approved at record-setting pace over the past 3 years for oncology and are widely used in Ireland. Currently in Ireland, patients on OAM are being treated in hospital day units by consultants, and their specialist teams. Increased use of OAM has put significant pressure on acute oncology services and is unsustainable. To address these issues, the National Cancer Strategy 2017-2026 recommended the development of a model of care for OAM. Nurse-led clinics, either face-to-face or virtually using technology, have emerged as an ideal means to achieve safe convenient care for individuals on OAMs. Research shows high levels of patient satisfaction with such nurse-led care with a positive impact on patient outcomes, patient satisfaction and access to care. Health services are now focused on keeping people in their communities and the Irish Sláintecare report (2018) aims to deliver care closer to the person's home. This is particularly pertinent during the COVID-19 pandemic to minimize hospital visits. This study aims to establish a new model of care for this cohort of patients which concord with the 2018 National Cancer Control Programme OAM Model of Care Recommendations. This pilot study will assess the safety and efficacy of the proposed model of care.

Who can participate?
Patients with cancer currently taking OAMs

What does the study involve?
Phase 1 will describe the current ANP-led Oral Anti-cancer Medication (OAM) virtual clinics established in response to COVID-19 pandemic and this phase will last for up to 1 year. Phase 2 aims to produce a protocol for a pilot study of an improved version of the current virtual clinic which is fit for purpose with or without the COVID context. Taking part involves giving consent for information on the individuals' healthcare to be collected for analysis. The participants will also be given the opportunity to share their opinions during group discussions (focus groups) or interviews to find out how the service can be improved.

What are the possible benefits and risks of participating?
A risk that potentially could occur is that a data breach that could cause an identity to be known, however, every effort will be made to maintain confidentiality in line with all data protection regulations. There is no direct benefit from participating in this study but information obtained may help direct the future management of patients on oral anti-cancer medication.

Where is the study run from?
Letterkenny University Hospital (LUH) and the National University of Ireland Galway (NUIG) (Ireland)

When is the study starting and how long is it expected to run for?
April 2020 to September 2022

Who is funding the study?
Irish Cancer Society (Ireland)

Who is the main contact?
Dr Janice Richmond
janicep.richmond@hse.ie

Trial website

Contact information

Type

Public

Primary contact

Dr Janice Richmond

ORCID ID

Contact details

Oncology Department
Letterkenny University Hospital
Letterkenny
F92 AE81
Ireland
+353 (0)749123648
janicep.richmond@hse.ie

Type

Scientific

Additional contact

Prof Andrew Murphy

ORCID ID

Contact details

National University of Ireland Galway
Galway
-
Ireland
+353 (0)91 524411
andrew.murphy@nuigalway.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CNRA19RICH

Study information

Scientific title

Establish and analyse the safety and efficacy of an integrated care model for the management of patients receiving oral anti-cancer agents in the community by an Advanced Nurse Practitioner (ANP): a pilot study

Acronym

ARC

Study hypothesis

The aim of this study is to analyse the safety and efficacy of a virtual ANP-led clinic for patients receiving OAM established in response to COVID-19 and plan for eventual transition care from the virtual ANP clinic to the community, within the Irish healthcare system.

Ethics approval

Approved 12/08/2020, Letterkenny University Hospital Ethics Committee (c/o General Managers Office, Letterkenny University Hospital, Co Donegal, Ireland; +353 (0)74 9123501; vanessa.savva@hse.ie), ref: not applicable

Study design

Collaborative multidisciplinary pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Individuals with cancer or taking oral anti-cancer medication (OAMs)

Intervention

This is a two-phase study, aiming to:
1. Design an ANP integrated oncology care model for the administration of OAM with input from local and national stakeholders and existing literature
2. Pilot test the feasibility, acceptability and costs of this model of care to inform the design of a future trial
The design of this study is based on the Development and Feasibility/piloting phases of the Medical Research Council (MRC) Framework for the development and evaluation of complex interventions to improve health

In consultation with local and national stakeholders and existing literature, the researchers will develop and refine this model of care. Focus groups/interviews will be conducted with healthcare providers and patients receiving OAMs, as this approach is appropriate for gathering different perspectives and to facilitate discussion, debate and problem-solving. Information collected on patients participating in this study will include a range of quantitative data. Attendance time, adverse events, adherence with taking medications as prescribed, frequency of contact with ANP are some of the data that will be collected. Questionnaires will be collected from participants to assess their health status, as well as their experience of the ANP model of care. Some patients will be asked to participate in one-to-one interviews with a member of the research team. The design of this study is based on the Development and Feasibility/piloting phases of the Medical Research Council (MRC) Framework for the development and evaluation of complex interventions to improve health. Use of the MRC framework ensures that a solid basis for an effective intervention is developed that is based on local knowledge and international evidence.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Quality of life measured using the EQ-5D-5L questionnaire at baseline and 6-month follow-up
2. The experiences of patients and healthcare providers gathered using qualitative interviews/focus groups at one timepoint during the intervention

Secondary outcome measures

1. Quantitative data describing the intervention, e.g. patient waiting time, and intervention outcomes, e.g. adverse events and toxicity, gathered using study logs and predesigned forms. Toxicity grading system will be used throughout. The forms to capture the specific data will be unique to this study and developed for its purpose. This data will be captured at each patient visit and will continue to be captured throughout the study period.
2. Healthcare resource use measured using questionnaire at baseline and 6-month follow-up

Overall trial start date

08/04/2020

Overall trial end date

14/09/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Currently receiving an oral anti-cancer treatment
2. Have received OAM within 6 months of data collection commencing
3. Aged 18 and over
4. Cognitively able to provide informed consent and complete the study activities
5. An ECOG performance status of 0-2

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Refusal to participate
2. Patients not taking oral anticancer medication.

Recruitment start date

14/09/2020

Recruitment end date

14/06/2021

Locations

Countries of recruitment

Ireland

Trial participating centre

Letterkenny University Hospital
Oncology Dept
Letterkenny
f92 ae81
Ireland

Sponsor information

Organisation

Irish Cancer Society

Sponsor details

Northumberland Road
Dublin 6
Dublin
Dublin 6
Ireland
+353 (0)12310500
research@irishcacner.ie

Sponsor type

Charity

Website

http://www.cancer.ie/#sthash.HEWHm6I3.dpbs

Funders

Funder type

Charity

Funder name

Irish Cancer Society

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

Ireland

Results and Publications

Publication and dissemination plan

Results will be shared with the study sponsor (Irish Cancer Society) and the National Cancer Control Programme and planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

14/09/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/11/2020: Trial's existence confirmed by the Irish Cancer Society.