Plain English Summary
Background and study aims
There is a risk of discrepancy between what patients with advanced cancer and their relatives think are unanswered questions and what is the actual subject of research. The aim of this study is to challenge conventions by inviting patients with life-threatening cancer, their relatives and patient organisations to join forces with clinical specialists and researchers in order to identify, discuss and prioritise issues for future research.
A steering group will monitor the development of the project, help to validate research issues and provide inspiration for future developments. Establishing a partnership between patients, relatives, clinical specialists and researchers can potentially open the door to new perspectives within Danish research. This initial study could lead to a larger international research programme that includes several populations diagnosed with life-threatening cancer.
Who can participate?
Adult patients with brain tumour or with acute leukaemia, relatives, representatives from relevant patient organisations and specialists. Participants will be selected according to specific criteria and receive an invitation.
What does the study involve?
A series of focus group interviews (FGI).
What are the possible benefits and risks of participating?
Not applicable – this is a qualitative study.
Where is the study run from?
The steering group consists of representatives from the hospital management at Rigshospitalet (Copenhagen), the Danish Cancer Society, patient organisations, the Danish Research Centre for Patient Support and Empowerment in the Capital Region of Denmark, the University Hospitals’ Center for Health Research (UCSF), the University of Copenhagen and the Section of Acute Pain Management and Palliative Medicine at Rigshospitalet.
When is the study starting and how long is it expected to run for?
May 2015 to April 2016.
Who is funding the study?
Danish Cancer Society
Who is the main contact?
Mrs Karin Piil
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Karin Piil
ORCID ID
http://orcid.org/0000-0001-7972-4674
Contact details
Rigshospitalet
University of Copenhagen
Dept. of Neurosurgery
Blegdamsvej 9
Copenhagen
2100
Denmark
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Supportive care, palliation and quality of life for patients with life-threatening cancer and their relatives: a partnership on research priorities
Acronym
Study hypothesis
There is a risk of discrepancy between what the patients with advanced cancer and their relatives experience as important unanswered questions and those which are actually researched. This pilot study challenges the conventional research process by inviting patients with life-threatening cancer, their relatives and patient organisations to join forces with clinical specialists and researchers to identify, discuss and prioritise issues for future research. The main focus of this project is supportive care and palliation as well as Health-related quality of life (HRQoL) in two patient groups with life-threatening illnesses (neuro-oncologic and malignant hematological diseases) and their families.
Ethics approval
This study has been registered by the Danish Data Protection Agency (file # RH-2015-106, 03871) and will be carried out in accordance with the Declaration of Helsinki. According to the Research Ethics Committee approval is not needed (file # H-15001485).
Study design
Qualitative study involving four focus group interviews (FGIs) for each included disease and treatment trajectory
Primary study design
Observational
Secondary study design
Qualitative study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Advanced cancer
Intervention
Two separate groups will be recruited for the FGIs:
1. Ten brain tumour patients and ten relatives together with one representative from a brain tumour patient organisation
2. Ten patients with acute leukaemia, ten relatives and one representative from the patient support organisation for lymphoma and leukaemia.
Six clinical specialists within neuro-oncology/surgery and six clinical specialists within hematology are also invitede for FGI.
Three separate, parallel FGIs will be conducted with patients, relatives and specialists respectively. They will serve to define areas, and a fourth follow-up FGI will bring together three representatives from each group to validate and prioritise these areas. A representative from the relevant patient organisation will participate in the FGIs, both with the patients and with the relatives.The research issues that are not sufficiently illuminated by existing research will be presented at this FGI with a view to validating and prioritising them.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. To establish meaningful cooperation between patients, relatives, specialists and researchers to identify, discuss and prioritise future research fields with a view to strengthening supportive care, palliative care and HRQOL including symptom management during and after the course of the disease and treatment
2. To examine existing literature on the identified fields to determine research relevance
Secondary outcome measures
To disseminate the findings and methods in a Danish context
Overall trial start date
01/05/2015
Overall trial end date
30/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Two separate groups will be recruited for the FGIs:
1. Ten brain tumour patients and ten relatives (not dyads) together with one representative from a brain tumour patient organisation
2. Ten patients with acute leukaemia, ten relatives one representative from the patient support organisation for lymphoma and leukemia (LyLe).
Participants must be a minimum of 18 years of age, have a Karnofsky Performance Status (KPS) of ≥ 60 and speak and understand Danish. Patients must have undergone at least two rounds of chemotherapy having experiences as a patient undergoing oncological treatment.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10 brain tumour patients and 10 relatives together with one representative from a brain tumour patient organisation, and 2) ten patients with acute leukemia, ten relatives and one representative from the patient support organisation for lymphoma and leukemia.
Participant exclusion criteria
1. Karnofsky Performance Status (KPS) of < 60
2. Under 18 years of age
Recruitment start date
15/08/2015
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Denmark
Trial participating centre
Rigshospitalet, University of Copenhagen
2100
Denmark
Trial participating centre
The University Hospitals Center for Health Research (UCSF) and Center for Integrated Rehabilitation of Cancer Patients (CIRE)
2100
Denmark
Sponsor information
Organisation
Rigshospitalet, University of Copenhagen UCSF 9701
Sponsor details
Blegdamsvej 9
Copenhagen
2100
Denmark
+45 (0)3545 3545
rigshospitalet@rh.regionh.dk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Kræftens Bekæmpelse
Alternative name(s)
Danish Cancer Society, The Danish Cancer Society, DCS
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit
Location
Denmark
Results and Publications
Publication and dissemination plan
The results papers will be published in December 2017
IPD sharing plan
The datasets generated during and/or analysed during the current study are not expected to be made available as they consist of sensitive and personal information
Intention to publish date
01/12/2017
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
1. 2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27221126
2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30345723 (added 24/01/2019)