Trial Outcomes & Findings for Long Term Survivors of High-grade Glioma and Their Caregivers (NCT NCT02965144)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

13 participants

Primary outcome timeframe

up to 5 months

Results posted on

2020-06-04

Participant Flow

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.

Participant milestones

Participant milestones
Measure	HGG Patients single-group study- long term survivors no treatment: no treatment
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long Term Survivors of High-grade Glioma and Their Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HGG Patients n=13 Participants single-group study- long term survivors no treatment: no treatment
Age, Continuous Age	56 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 5 months

Population: The dataset was analysed according to the steps described by Braun and Clarke in "Using Thematic analysis in psychology".

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.

Outcome measures

Outcome measures
Measure	HGG Patients n=13 Participants 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.
Number of Participants Identifying With the Three Main Themes Identified	13 Participants

SECONDARY outcome

Timeframe: Baseline

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).

Outcome measures

Outcome measures
Measure	HGG Patients n=13 Participants 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.
The Hospital Anxiety and Depression Scale (HADS) anxiety	5.50 units on a scale Standard Deviation 5.17
The Hospital Anxiety and Depression Scale (HADS) depression	4.15 units on a scale Standard Deviation 4.00

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	HGG Patients n=13 Participants 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.
The WHO Performance Scale PS value 0	5 Participants
The WHO Performance Scale PS value 1	6 Participants
The WHO Performance Scale PS value 2	1 Participants
The WHO Performance Scale PS value 3	1 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Quality of life

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.

Outcome measures

Outcome measures
Measure	HGG Patients n=10 Participants 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.
The Functional Assessment of Cancer Therapy, General (FACT-G) FACT-G	86.45 units on a scale Standard Deviation 20.03
The Functional Assessment of Cancer Therapy, General (FACT-G) FACT-Br	147.71 units on a scale Standard Deviation 40.3

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	HGG Patients n=10 Participants 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.
Questionnaire on Leisure Time Physical Activity Level Leisure time I	2 Participants
Questionnaire on Leisure Time Physical Activity Level Leisure time II	2 Participants
Questionnaire on Leisure Time Physical Activity Level Leisure time III	5 Participants
Questionnaire on Leisure Time Physical Activity Level Leisure time IV	1 Participants

Adverse Events

HGG Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karin Piil

Rigshospitalet

Phone: 0045612078067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place