Condition category
Cancer
Date applied
03/10/2014
Date assigned
03/10/2014
Last edited
12/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Miss Lesley Dunleavy

ORCID ID

Contact details

International Observatory on End of Life Care
School of Health and Medicine
Bowland Tower East
Bailrigg
Lancaster
LA1 4YT
United Kingdom
-
l.dunleavy@lancaster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17231

Study information

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

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

14/NW/1189; First MREC approval date 21/08/2014

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/11/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1360; UK Sample Size: 272

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

31/12/2016

Locations

Countries of recruitment

Belgium, Denmark, Italy, Netherlands, Slovenia, United Kingdom

Trial participating centre

Lancaster University
Lancaster
LA1 4YT
United Kingdom

Sponsor information

Organisation

Lancaster University (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27059593

Publication citations

Additional files

Editorial Notes

12/04/2016: Publication reference added. On 17/11/2014 the Netherlands, Italy, Belgium, Denmark and Slovenia were added to the countries of recruitment.