Condition category
Cancer
Date applied
19/04/2013
Date assigned
08/05/2013
Last edited
23/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
High-grade gliomas (HGG) are the most malignant type of brain tumors. The 5-year survival is 10 % and a significant part of ongoing research aims to increase survival through surgical and oncological treatments. Accordingly, there is an increasing need for investigating the HGG disease prognosis in order to recommend specific survivorship guidelines for rehabilitative and supportive interventions. The study aims to understand patients and relatives life situation, needs, wishes and preferences for rehabilitative interventions during and after surgical and medical treatment for high grade glioma. Furthermore, the aim is to develop and test a rehabilitative intervention based on patient and family perspectives and existing literature.

Who can participate?
Patients with HGG (WHO grade III and IV) with or without their caregiver.

What does the study involve?
The study is conducted in 2 phases . Phase 1 is an explorative and descriptive interview study of patients and their relatives' life situation and needs for rehabilitation as well as a quantitative evaluation of the patients´ health related quality of life. Phase 2 is a pilot study testing a rehabilitative intervention program. The intervention program is developed from existing intervention literature and the findings from phase 1 of the study.

What are the possible benefits and risks of participating?
Being interviewed by a nurse specialist e.g. about the life situation can have a positive gain for the participants as the interview can help the participants clarify their thoughts. After the interviews it is possible for the participants to ask the nurse specialist any questions that might persist. There are no risks related to participation.

Where is the study run from?
University Hospital of Copenhagen (Denmark)

When is the study starting and how long is it expected to run for?
May 2012 to May 2015

Who is funding the study?
1. The Center for Integrated Rehabilitation of Cancer Patients (CIRE) (Denmark)
2. The Neuro Center at Copenhagen University Hospital; Rigshospitalet (Denmark)
3. The Danish Cancer Society (Denmark)
4. The Novo Nordisk Foundation (Denmark)
5. Torben and Alice Frimodts Foundation (Denmark)
6. Vera and Flemming Westerbergs Foundation (Denmark)
7. Hetland Olsen’s Foundation (Denmark)

Who is the main contact?
Karin Piil
Karin.piil@regionh.dk

Trial website

https://patientnetvaerk.sundhed.dk/hjernekraeftnetvaerk/default.aspx

Contact information

Type

Scientific

Primary contact

Mrs Karin Piil

ORCID ID

Contact details

University Hospital of Copenhagen
Neurosurgery dept. 3090
Blegdamsvej 9
Copenhagen
2100
Denmark
+ 45 (0)61 27 80 67
Karin.piil@regionh.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The feasibility of a brain tumor website among patients with high-grade gliomas and the caregivers

Acronym

Study hypothesis

The literature that addresses the supportive, rehabilitative and palliative needs still remains limited and reflects a gap in the existing knowledge regarding the breadth of needs across the disease and treatment trajectory for patients with HGG and their caregivers. This study adds knowledge to the growing body of existing research of the life situation and the longitudinal needs and preferences for rehabilitative and supportive care interventions in patients with HGG and their caregivers. Moreover, we studied the feasibility and safety of an Internet-based intervention. This mixed methods study is divided into two phases. First, a longitudinal, qualitative, explorative and descriptive interview study of the life situation and need for rehabilitation among patients and their caregivers were carried out. Moreover, a quantitative evaluation of health-related quality of life using patient-reported outcomes was conducted. In the second phase a Danish Brain Tumor Website (BTW) was developed based on professional clinical, scientific knowledge and evidence as well as from the findings from the previous phase. The feasibility and safety was explored in a feasibility study using a mixed methods design including a qualitative semi-structured interview study and statistics regarding the users of the website was extracted using the Google Analytics.

Ethics approval

Registered by the Danish Data Protection Agency (2007-58-0015) and Danish Data Protection Agency (30-1219/02865) and will be carried out in accordance with the Declaration of Helsinki.
1. No approval needed for phase I.
2. Phase II: The Ethical Committee at the Capital Region of Denmark, ref: H-2-2013-135

Study design

This mixed methods study investigates the feasibility of a newly developed nationwide Danish Brain Tumor Website.

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

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

Condition

Patients with primary malignant brain tumor of the type high-grade glioma (WHO grade III/VI).

Intervention

Phase I: Participants will be interviewed individually five times over a 12 months period starting at baseline (Test 1: time of diagnosis). Test 2 takes place 5-6 weeks post-operatively, which is approximately 2 weeks after initiation of the oncological treatment. Test 3 is at 28 weeks (after first treatment response scan) and test 4 is at 40 weeks (after second treatment response scan). Test 5 takes place after one year at study end. The patients will be asked to complete questionnaires at all five test points.

Phase II: The intervention program will be developed after phase I. Two separate samples will collected:
1. A nationwide sample studying BTW participation after six months
2. A sample of patients with HGG and their caregivers interviewed three months after being introduced to the BTW.
The interactive Brain Tumor Website (BTW) (hjernekraeftnetvaerk.dk) provides specific HGG information and links to quality websites, a disease and treatment specific dictionary, an ask-the-specialist function, online support groups for sharing experiences and weekly access to an open telephone line with the moderator.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary aim of phase I is to explore the life situation, needs and experiences across the disease and treatment continuum in patients diagnosed with HGG and their caregivers.

The aim of phase II is to study the feasibility of a survivorship program designed from the perspectives in the existing literature and the experiences of the patients and their caregivers obtained in the present study.

Data includes:
1. The number of users
2. Logged-in members
3. Postcodes from which the BTW was accessed
4. Types of devices used to access the BTW
5. Number of first time versus returning users
6. Type of activity (number of sessions, most visited pages, use of telephone support)

Individual telephone interviews were conducted with the participants by the principal investigator and clinical specialist after three months. Using a semi-structured interview guide, participants were asked to share their experiences and evaluation of the BTW.

Secondary outcome measures

1. To systematically assess the patients´ needs for rehabilitation along the course of the disease
2. To describe how symptoms are experienced and managed
3. To elucidate the resources of the caregivers and any independent needs related to the patient's disease
4. To gain an understanding of what a survivorship program should comprise
5. To develop a targeted intervention for rehabilitation of patients with HGG and their caregivers
6. Assess safety of the BTW

Overall trial start date

01/05/2012

Overall trial end date

30/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. A diagnosis of HGG (WHO grade III/IV) in persons > 18 years of age, either sex that are capable of speaking and understanding Danish and that have a Karnofsky performance score (KSP) > 60 at baseline
2. Caregivers are eligible if they are named by the patient as the most involved caregiver, and will provide written informed consent
3. Access to the Internet

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

30 patients and 30 caregivers in phase 1. At present the number in phase II is unknown.

Participant exclusion criteria

1. Karnofsky performance score < 60 at baseline
2. Other types of primary brain tumors than HGG
3. No Internet access
4. No standard treatment

Recruitment start date

01/05/2012

Recruitment end date

30/04/2014

Locations

Countries of recruitment

Denmark

Trial participating centre

University Hospital of Copenhagen
Copenhagen
2100
Denmark

Sponsor information

Organisation

Copenhagen University Hospital

Sponsor details

c/o Karin Piil
Rigshospitalet
Neurosurgery dept. 3090
Blegdamsvej 9
Copenhagen
2100
Denmark
+45 (0)61 27 80 67
Karin.piil@rh.regionh.dk

Sponsor type

Hospital/treatment centre

Website

http://www.rigshospitalet.dk

Funders

Funder type

Hospital/treatment centre

Funder name

The Center for Integrated Rehabilitation of Cancer Patients (CIRE) (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Neuro Center at Copenhagen University Hospital, Rigshospitalet (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Novo Nordisk Foundation (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Torben og Alice Frimodts Fond

Alternative name(s)

Torben and Alice Frimodt's Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Denmark

Funder name

Vera and Flemming Westerbergs Foundation (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hetland Olsen Fund

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Denmark

Funder name

Kræftens Bekæmpelse

Alternative name(s)

Danish Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Denmark

Results and Publications

Publication and dissemination plan

Plans for publication:

Daily life experiences of patients with high-grade gliomas and their caregivers - a longitudinal exploration of rehabilitation and supportive care needs.Piil K, Juhler M, Jakobsen J, Jarden M. Accepted for publication in Journal of Neuroscience Nursing.

Health-related Quality of life in patients with high-grade gliomas - A quantitative longitudinal study
The Feasibility of a Brain Tumor Website

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26051074

Publication citations

  1. Piil K, Juhler M, Jakobsen J, Jarden M., Controlled rehabilitative and supportive care intervention trials in patients with high-grade gliomas and their caregivers: a systematic review, BMJ Support Palliat Care, 2014, doi: 10.1136/bmjspcare-2013-000593.

  2. Piil K, Jarden M, Jakobsen J, Christensen KB, Juhler M., A longitudinal, qualitative and quantitative exploration of daily life and need for rehabilitation among patients with high-grade gliomas and their caregivers., BMJ Open, 2013, doi: 10.1136/bmjopen-2013-003183.

Additional files

Editorial Notes

23/09/2016: Publication reference added. 06/02/2015: this trial record was amended to add information from phase II of the study. The following changes have taken place: 1. Ethics approval for phase II has been added. 2. Both the public and scientific title was changed to reflect overall study. 3. Study hypothesis was changed to reflect overall study. 4. Phase II interventions were added.