Meaningful contextual communication in cancer care
| ISRCTN | ISRCTN14737915 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14737915 |
- Submission date
- 07/09/2021
- Registration date
- 15/09/2021
- Last edited
- 15/09/2021
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Contextual care is the continuous, ongoing process of identifying individual patient circumstances (their context) and, if necessary, modifying the plan of care to accommodate those circumstances. It is about essential patient needs that need to be addressed.
Being confronted with the reality of having advanced cancer may give rise to life questions, and subsequent struggles such as fear, anger, loss of independence, changing self-image, roles and relationships and failure to find meaning are frequently reported amongst patients.
This project will focus on increasing meaningful contextual communication between health care professionals (HCPs) and patients with advanced cancer, considering differences across Europe in both clinical and ethical aspects. The challenge addressed by this project is to develop an intervention founded on a European-wide set of central educational design principles, in order to increase the competence of specialised palliative care HCPs in meaningful contextual communication (what does it mean for this patient at this moment to live with his or her illness?), and as a result to increase QoL of patients with advanced cancer throughout Europe.
Who can participate?
Adult (over 18 years of age) patients with advanced cancer and their family caregivers under treatment of included multidisciplinary teams in palliative care.
What does the study involve?
An observational pre-study in which participants will randomly be invited for an interview or focus group.
A communication training for HCPs working in multidisciplinary teams for palliative care (5 steps in 5 months).
HCPs, patients, and their family caregivers will be interviewed before and after the communication training to assess impact of training.
What are the possible benefits and risks of participating?
Benefits: increased meaningful contextual communication, resulting in increased job satisfaction for HCPs, increased QoL for patients and family caregivers, increased cost-effectiveness.
Risks: None
Where is the study run from?
Radboud University Nijmegen Medical Centre (Netherlands)
When is the study starting and how long is it expected to run for?
September 2021 to June 2028
Who is funding the study?
EU (HORIZON-21)
Who is the main contact?
Dr Anne Wichmann (anne.wichmann@radboudumc.nl)
Contact information
Scientific
Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands
 ORCID ID |
0000-0003-0085-9782 |
|---|---|
| Phone | +31 628744811 |
| anne.wichmann@radboudumc.nl |
Study information
| Study design | Interventional uncontrolled pre-post study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | A mixed-method implementation study of a design-based educational intervention to enhance meaningful contextual communication in care planning with advanced cancer patients and their families across Europe |
| Study acronym | onCOntext |
| Study objectives | The introduction of the onCOntext intervention will improve meaningful contextual communication. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Increasing meaningful contextual communication between multidisciplinary palliative care teams, patients with advanced cancer and their family caregivers. |
| Intervention | The observational cross-sectional study in year 1 comprises of a comprehensive European-wide (The Netherlands, Belgium, Scotland, Switzerland, Poland, Turkey, Spain, Italy) qualitative current practice study amongst HCPs (N=80), patients with advanced cancer (N=80) and their family caregivers (N=80) on i) the perspectives on current practice regarding meaningful contextual communication in palliative care, its integration in care planning and serious late and long-term side effects; ii) how these stakeholders from different European cultures understand meaningful contextual communication in palliative care; iii) how HCPs define the concept ‘meaningful contextual communication’ and which ‘language’ they use for it; iv) what makes team-based learning in European palliative care work? For point iv, additionally two focus groups per country (total N=16) will be conducted with 10-15 stakeholders (total N≈200). It will take approximately a year. The interventional pre- post effect measurement study in year 3 consists of i) prospective interviews conducted amongst HCPs (N≈150), patients (N≈150) and family caregivers (N≈150); ii) 4C coding of audio-recorded consultations (N≈320); iii) a structured retrospective after-death questionnaire study amongst HCP most involved in care (N≈800) and a family caregiver closely involved (N≈800), also about the patient*. * all participating teams retrospectively report all deaths of patients over a three month period, about whom the HCP and family caregiver will also answer questions. Using a three-month period limits recall bias and has been tested previously. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Observational pre-study: current practice, perspectives, cultures measured amongst HCPs, patients, family caregivers and relevant experts using interviews (N=80 per stakeholder group) Main interventional study: 2. Experiences of HCPs, patients and their family caregivers with current care measured using interviews at baseline (T0) and 3-6 months post-intervention (T1) 3. Contextual communication measured in audio-taped consultations using 4C coding, at baseline (T0) and 3-6 months post-intervention (T1) |
| Secondary outcome measures | 1. HCP competence measured using questionnaire (SCCS), at baseline (T0) and 3-6 months post-intervention (T1) 2. HCP job satisfaction measured using questionnaire (NEXT study), at baseline (T0) and 3-6 months post-intervention (T1) 3. Patient QoL measured using questionnaires (EQ5D-5L, FACIT-Sp, ICECAP-SCM) at baseline (T0) and 3-6 months post-intervention (T1) 4. Family caregiver burden measured using questionnaire (CRA) at baseline (T0) and 3-6 months post-intervention (T1) 5. Costs measured using consultation length and questionnaire (RUD) at baseline (T0) and 3-6 months post-intervention (T1) |
| Overall study start date | 01/09/2021 |
| Completion date | 01/06/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 800 |
| Key inclusion criteria | Adult (>18 years of age) patients with advanced cancer and their family caregivers under treatment of included multidisciplinary teams in palliative care |
| Key exclusion criteria | 1. Patients with intellectual disabilities 2. Children |
| Date of first enrolment | 01/06/2025 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Belgium
- Italy
- Netherlands
- Poland
- Scotland
- Spain
- Switzerland
- Türkiye
- United Kingdom
Study participating centres
Netherlands
EH8 9AG
United Kingdom
2610
Belgium
Poland
Türkiye
Italy
Spain
Switzerland
Sponsor information
Hospital/treatment centre
Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 361 1111 |
|---|---|
| digitalezorg@radboudumc.nl | |
| Website | https://www.radboudumc.nl/EN/Pages/default.aspx |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 01/06/2029 |
|---|---|
| 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-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
08/09/2021: Trial's existence confirmed by Radboud University Nijmegen Medical Centre.
