ACTION: cancer patient involvement in medical decision making

ISRCTN	ISRCTN63110516
DOI	https://doi.org/10.1186/ISRCTN63110516
Secondary identifying numbers	17231

Submission date: 03/10/2014
Registration date: 03/10/2014
Last edited: 16/12/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-a-new-way-to-help-people-with-advanced-cancer-plan-their-care-now-and-in-the-future-action

Study website

Contact information

Dr Nancy Preston
Scientific

International Observatory on End of Life Care
Faculty of Health and Medicine
Lancaster University
Lancaster
LA1 4YG
United Kingdom

Phone	01524 592802
Email	n.j.preston@lancaster.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Process of Care
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	ACTION: a phase III multicentre cluster randomised clinical trial to assess whether the 'Respecting Choices Program' improves quality of life and symptoms of patients with advanced cancer
Study acronym	ACTION
Study hypothesis	The overall hypothesis for the ACTION study is that formalised advance care planning significantly improves quality of life and reduces symptoms of patients with advanced cancer.
Ethics approval(s)	14/NW/1189; First MREC approval date 21/08/2014
Condition	Topic: Cancer; Subtopic: Colorectal Cancer, Lung Cancer; Disease: Colon, Lung (small cell), Lung (non-small cell)
Intervention	The ACTION study is a cluster randomised control trial in which potential participants are randomised in groups (i.e. the group is randomised not the individual). In this case, the hospitals taking part in the study are treated as the cluster of patients and randomised as a unit. Pairs of comparable hospitals have been randomised at the start of the study to provide either advance care planning (in the intervention hospitals) or 'standard care' ( in the control hospitals). In this study, only the intervention hospitals will be exposed to the 'Respecting Choices Program' but it is acknowledged that other advance care planning activities may take place in the control hospitals as part of 'standard care'. The 'Respecting Choices Program' is a formalised model of advance care planning developed and currently being used in the United States and Australia. In this programme, a trained 'Respecting Choices Facilitator' invites patients to reflect on their personal goals, values and beliefs, to discuss and document their choices regarding their future treatment and care and to nominate someone who they may wish to be consulted about their treatment or care if they are not able to make decisions for themselves. After consenting to take part in the study, participants in the intervention hospitals are invited to take part in two advance care planning interviews with a trained 'Respecting Choices' facilitator in a location convenient to the patient. Patients will continue to be under the care of their health care team while on the study and after their involvement in the study has ended.
Intervention type	Other
Primary outcome measure	Quality of life and symptoms; Timepoint(s): Baseline, 10-12 and 18-20 weeks (both control and intervention group)
Secondary outcome measures	1. Coping with their illness; Timepoint(s): Baseline, 10-12 and 18-20 weeks (both control and intervention group) 2. Decisional Quality and Patient Activation; Timepoint(s): Baseline, 10-12 and 18-20 weeks (both control and intervention) 3. Satisfaction with care; Timepoint(s): Baseline, 10-12 and 18-20 weeks (both control and intervention group) 4. Satisfaction with the intervention; Timepoint(s): 10-12 and 18-20 weeks (intervention group only)
Overall study start date	01/11/2014
Overall study end date	30/11/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 1360; UK Sample Size: 272
Total final enrolment	1117
Participant inclusion criteria	Adult patients with advanced stages of lung or colorectal cancer. Patients need to have an estimated life expectancy of at least three months. The patients will be under the care of the oncologist at the participating hospitals. Histologically confirmed diagnosis of: 1. Lung cancer: 2. Small cell extensive disease/ Stage III or IV* 3. Nonsmall cell stage III or IV* 4. Colorectal cancer: Stage IV * *according to 7th edition of TNM classification and staging system 5. Written informed consent to participate 6. World Health Organisation performance status of 3 or under
Participant exclusion criteria	1. Age less than 18 years 2. Unable to provide consent 3. Unable to complete questionnaire in country's language 4. Less than 3 months anticipated life expectancy 5. Taking part in a research study that is evaluating palliative care services or communication strategies
Recruitment start date	01/11/2014
Recruitment end date	01/06/2018

Locations

Countries of recruitment

Belgium
Denmark
England
Italy
Netherlands
Slovenia
United Kingdom

Study participating centres

Lancaster University

Lancaster
LA1 4YT
United Kingdom

Ikazia Hospital

Montessoriweg 1
Rotterdam
3083 AN
Netherlands

Reinier de Graaf Hospital

Reinier de Graafweg 5
Delft
2625 AD
Netherlands

Sponsor information

Lancaster University (UK)
University/education

Research Support Office B58, Bowland Main
Bailrigg
Lancaster
LA1 4YT
England
United Kingdom

"ROR"	https://ror.org/04f2nsd36

Funders

Funder type

Government

Seventh Framework Programme
Government organisation / National government

Alternative name(s): EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high level peer reviewed journal towards the end of 2018 or early 2019.
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Protocol article	protocol	08/04/2016		Yes	No
Results article	focus group results	31/10/2019	04/11/2019	Yes	No
Other publications	coping strategies of patients	01/02/2020	07/10/2020	Yes	No
Results article	results	13/11/2020	02/12/2020	Yes	No
Other publications	serious adverse event reporting procedures	20/01/2021	22/01/2021	Yes	No
Results article	Healthcare use and healthcare costs	14/12/2022	16/12/2022	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

16/12/2022: Publication reference added.
25/06/2021: Cancer Research UK lay results summary link added to Results (plain English).
22/01/2021: Publication reference added.
02/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
07/10/2020: Publication reference added.
04/11/2019: Publication reference added.
20/12/2017: The following changes were made:
1. The overall trial end date was updated from 31/12/2016 to 30/11/2018.
2. The recruitment end date was updated from 31/12/2016 to 01/06/2018.
3. Publication plan, patient level data and two trial participating centres were added.
4. Dr Nancy Preston replaced Miss Lesley Dunleavy as the study contact.
12/04/2016: Publication reference added.
On 17/11/2014 the Netherlands, Italy, Belgium, Denmark and Slovenia were added to the countries of recruitment.