We will investigate whether the Respecting Choices program will improve communication between patients and healthcare professionals, will improve the QOL and wellbeing of patients and their relatives, will reduce futile treatments and unnecessary…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of Life (EORTC QLQ-C30; EORTC item bank EF short form), Symptoms (EORTC
QLQ-C15 PAL)
Qualitative study: patient experiences
Secondary outcome
Decisional quality (self constructed), Patient Activation (APECC), Satisfaction
with care (EORTC IN-PATSAT32), Coping with their illness (COPE), Satisfaction
with intervention (Patient Feedback Questionnaire), Socio demographic measures.
Experiences of ospital care as reported by bereaved relatives (VOICES), anxiety
and depression of bereaved relatives (HADS).
Alignment of care as preferred (as indicated by the patient) with care as
received (as measured in the medical files).
Background summary
Patients with advanced cancer typically experience multiple symptoms and suffer
from a reduced quality of life. Diagnosis of advanced cancer often has a
tremendous impact on the patients' emotional wellbeing. Advance Care Planning
(ACP) is a formalised process of communication between patients, relatives and
professional caregivers. A review of the literature demonstrates that one of
the most promising ACP programmes is the *Respecting Choices Program*.
Study objective
We will investigate whether the Respecting Choices program will improve
communication between patients and healthcare professionals, will improve the
QOL and wellbeing of patients and their relatives, will reduce futile
treatments and unnecessary hospitalisations, will enhance provision of care
consistent with patient goals and will increase satisfaction with care.
The qualitative interview study will explore patient experiences.
Study design
Phase III multicentre cluster-randomised clinical trial (CRCT) in six European
countries: Belgium, Denmark, Italy, the Netherlands, Slovenia and the United
Kingdom.
The qualitative study will be conducted in the Netherlands, Italy and the
United Kingdom.
Intervention
In the Respecting Choices intervention, a trained facilitator (usually a nurse)
in collaboration with attending physicians encourages patients to reflect on
their goals, values and beliefs, to discuss and document their future choices,
and to appoint a surrogate decision maker.
Study burden and risks
The only potential disadvantage is that participants are invited to talk about
topics that may make them feel uncomfortable. Participating in the study also
takes time.
Wytemaweg 80 -
Rotterdam 3015 CN
NL
Wytemaweg 80 -
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Patients:
- Histologically confirmed diagnosis of: lung cancer (small cell * extensive disease/ stage III or IV, non-small cell stage III or IV) or colorectal cancer stage IV or metachronous metastases
- written informed consent to participate
- WHO performance status of 3 or under ;Carers:
By participating patient identified as next of kin to be contacted by hospital staff if needed ;...
Exclusion criteria
Patients:
- Age < 18 years
- Unable to provide consent
- Unable to complete questionnaire in country*s language
- Less than 3 months anticipated life expectancy
- Taking part in a research study that is evaluating palliative care services or communication strategies;Carers:
None
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN63110516 |
| CCMO | NL50012.078.14 |