Condition category
Cancer
Date applied
10/07/2015
Date assigned
04/08/2015
Last edited
22/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
2100 Copenhagen
2100
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

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 below 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 measures

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

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 3545 3545
rigshospitalet@rh.regionh.dk

Sponsor type

Hospital/treatment centre

Website

www.rh.dk

Funders

Funder type

Charity

Funder name

The Danish Cancer Society

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A protocol paper (Octobber 2015) and results papers (April 2016).

Intention to publish date

30/04/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes