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Long Term Survivors of High-grade Glioma and Their Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02965144
Recruitment Status : Completed
First Posted : November 16, 2016
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Karin Piil, Rigshospitalet, Denmark

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Quality of Life
Brain Diseases
Depression
Physical Impairment
Intervention Other: no treatment
Enrollment 13
Recruitment Details A database comprised 18 patients, who were screened; 1 declined participation due to lack of motivation and 4 were lost to follow-up during screening. A total of 13 pt were enrolled, started the study and completed the study.
Pre-assignment Details  
Arm/Group Title HGG Patients
Hide Arm/Group Description

single-group study- long term survivors

no treatment: no treatment
Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title HGG Patients
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single-group study- long term survivors

no treatment: no treatment
Overall Number of Baseline Participants 13
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HGG patients diagnosed for more than 3 years ago
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Age Number Analyzed 13 participants
56
(31 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
7
  53.8%
Male
6
  46.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
13
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants Identifying With the Three Main Themes Identified
Hide Description Interviews seek to explore the perspectives on the life situation and quality of life Analysis of the interviews identified three main themes, shared by all the patients : (1) Searching for meaningful activities. (2) Selecting information that enhances self-management strategies. (3) Protection for safety reasons.
Time Frame up to 5 months
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Hide Analysis Population Description
The dataset was analysed according to the steps described by Braun and Clarke in "Using Thematic analysis in psychology".
Arm/Group Title HGG Patients
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single-group study- long term survivors

no treatment: no treatment Analysis of the interviews identified three main themes, shared by patients and their caregivers: (1) Searching for meaningful activities. (2) Selecting information that enhances self-management strategies. (3) Protection for safety reasons.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
13
 100.0%
2.Secondary Outcome
Title The Hospital Anxiety and Depression Scale (HADS)
Hide Description

The questionnaire is divided into two sub-scales for anxiety and depression with seven questions each all; 14 questions are rated on a four-point scale representing the degree of distress [0 = none, 4 = unbearable]. The responses from HADS are presented as mean scores for anxiety and depression.

Higher scores indicating worse outcome for depression (range 0.00-16.00) and anxiety (range 0.00-16.00).
Time Frame Baseline
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[Not Specified]
Arm/Group Title HGG Patients
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single-group study- long term survivors
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
anxiety 5.50  (5.17)
depression 4.15  (4.00)
3.Secondary Outcome
Title The WHO Performance Scale
Hide Description The Performance Scale covers a rating from 0 to 5; 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; 5= Dead
Time Frame Baseline
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title HGG Patients
Hide Arm/Group Description:

single-group study- long term survivors

no treatment: no treatment
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
PS value 0
5
  38.5%
PS value 1
6
  46.2%
PS value 2
1
   7.7%
PS value 3
1
   7.7%
4.Secondary Outcome
Title The Functional Assessment of Cancer Therapy, General (FACT-G)
Hide Description FACT-Br total score range 84.00-195.67 The FACT-G total score provides a summary of the overall HRQOL [range 0-108]. The higher the score, the better HRQOL.
Time Frame Baseline
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Quality of life
Arm/Group Title HGG Patients
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single-group study- long term survivors
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
FACT-G 86.45  (20.03)
FACT-Br 147.71  (40.3)
5.Secondary Outcome
Title Questionnaire on Leisure Time Physical Activity Level
Hide Description 0=fully active; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=ambulatory and capable of all self-care but unable to carry but any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, 4=bedbound, completely disabled
Time Frame Baseline
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title HGG Patients
Hide Arm/Group Description:

single-group study- long term survivors

no treatment: no treatment

Concerning depression, HADS showed moderate depressive symptoms in one patient (10%), and none of the patients reported having severe symptoms. Our data seem to be lower for anxiety (5.5±5.17) compared with the normative value (of 6.14±3.76), and higher for depression (4.15±4.0) compared with the normative value (of 3.68±3.07).
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Leisure time I
2
  20.0%
Leisure time II
2
  20.0%
Leisure time III
5
  50.0%
Leisure time IV
1
  10.0%
Time Frame adverse events were not monitored/assessed
Adverse Event Reporting Description adverse events were not monitored/assessed
 
Arm/Group Title HGG Patients
Hide Arm/Group Description

single-group study- long term survivors

no treatment: no treatment
All-Cause Mortality
HGG Patients
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
HGG Patients
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HGG Patients
Affected / at Risk (%)
Total   0/0 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Karin Piil
Organization: Rigshospitalet
Phone: 0045612078067
EMail: Karin.Piil@regionh.dk
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Karin Piil, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02965144    
Other Study ID Numbers: LTS01
First Submitted: November 9, 2016
First Posted: November 16, 2016
Results First Submitted: March 12, 2020
Results First Posted: June 4, 2020
Last Update Posted: June 4, 2020