GliomaGliomaNCT06713395
PERMA-Based Intervention on Negative Emotions, Adherence, and Complications in Postoperative Glioma Patients
A study testing PERMA in people with Glioma, run by Yang Huang at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate whether a PERMA-based integrated psychological intervention can reduce negative emotions, enhance treatment adherence, and decrease the risk of complications in postoperative glioma patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma
- What is being tested?
- PERMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2022to 25 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ①Meeting the relevant diagnostic criteria from the 5th edition of the World Health Organization Classification of Central Nervous System (CNS) Tumors, and confirmed through postoperative pathological examination;
- ②Underwent surgical treatment;
- ③Clear consciousness, with good communication ability, and capable of cooperating with healthcare personnel to complete the study;
- ④Complete clinical data.
Who cannot join
- ①Concurrent diagnosis of other malignant tumors;
- ②Coexisting cognitive impairment or other psychiatric disorders;
- ③Combined liver or kidney dysfunction, immune system disorders, or other severe diseases;
- ④Presence of infectious diseases;
- ⑤Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Brain Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: Analysis of the Effects of PERMA-Based Integrated Psychological Intervention on Negative Emotions, Treatment Adherence, and Complications in Postoperative Glioma Patients
The goal of this clinical trial is to evaluate whether a PERMA-based integrated psychological intervention can reduce negative emotions, enhance treatment adherence, and decrease the risk of complications in postoperative glioma patients.
The main questions it aims to answer are:
Read more
Can the PERMA-based psychological intervention significantly improve anxiety and depression scores in postoperative glioma patients? Does the intervention improve treatment adherence, reduce complications, and enhance quality of life compared to standard care? Researchers will compare an observation group receiving the PERMA-based psychological intervention to a control group receiving standard postoperative care to see if the intervention improves patient outcomes.
Participants will:
Receive either standard postoperative care (control group) or PERMA-based psychological intervention for one month (observation group).
Be assessed on:
Self-Rating Depression Scale (SDS) and Self-Rating Anxiety Scale (SAS). Treatment Adherence Scale and Complication Record Form. Quality of Life Scale. Be followed for complications using Kaplan-Meier survival analysis.
- Conditions
- Glioma
- Being tested
- The control group received standard postoperative care, PERMA
- Keywords
- PERMA, Glioma, Integrated psychological intervention, SAS, SDS, complication
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The control group received standard postoperative careOther
standard postoperative care
PERMAOther
- Establishment of the Integrated Psychological Intervention Team: The team consisted of 2 primary nurses, 4 specialist nurses, 1 psychologist, 2 physicians at the attending level or higher, and 2 researchers. Team Responsibilities: The primary and specialist nurses were responsible for implementing the intervention protocol. The physicians handled any adverse reactions experienced by the patients. The researchers were in charge of developing the intervention protocol and collecting data. All team members were required to undergo specialized training from the psychologist and pass an assessment before initiating the intervention.
- Protocol Development: The intervention protocol, including specific content, team responsibilities, implementation process, and responses to adverse events, was carefully developed in written form by the researchers. The protocol was discussed and approved by all team members before implementation.
- Protocol Implementation:
Emotional Support Intervention:
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | The control group was provided with standard postoperative care Receives: Other: The control group received standard postoperative care |
| observation group | Other | The observation group received an additional PERMA-based integrated psychological intervention Receives: Other: PERMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAS score
Self-rating anxiety scale is a widely used psychological assessment tool designed to evaluate an individual's level of anxiety. There are 20 things on the scale, and a score of 100 is the total, assessing various anxiety-related emotions experienced by the participant over the past week. Each item is rated on a 4-point Likert scale, ranging from "no anxiety" to "extremely severe anxiety," where higher scores indicate more severe anxiety. Prior to and one month following the intervention, the SAS scores for each group were documented.
Measured: After the four-week intervention
SDS score
Self-rating depression scale is a commonly used psychological assessment tool designed to evaluate an individual's level of depression. The scale typically consists of 20 items, with a total score of 100, covering various aspects of depression. Using a 4-point Likert scale that goes from "no depression" to "extremely severe depression," participants describe their moods over the course of the previous week. Higher scores signify more severe depression. The SDS scores for both groups were recorded before and one month after the intervention.
Measured: After the four-week intervention
treatment adherence
Complete adherence: The patient actively cooperated with the medical and nursing staff, followed all prescribed treatments and interventions, and complied with medication, examinations, and other medical recommendations on a daily basis. Partial adherence: The patient generally cooperated with the medical and nursing staff but may not have fully adhered to all instructions. Non-adherence: The patient showed poor cooperation, requiring multiple reminders and explanations to comply with treatment protocols. The adherence rate was calculated as the sum of the complete and partial adherence rates. Adherence was recorded one month after the intervention.
Measured: After the four-week intervention
Incidence of postoperative complications
Measured: During the four-week intervention
The World Health Organization Quality of Life Brief Scale scores
WHOQOL-BREF is a tool used to assess an individual's quality of life. This scale consists of 26 items, each with five options, rated from 1 to 5, with higher scores reflecting better outcomes (or from very satisfied to extremely dissatisfied). However, items 3, 4, and 26 are reverse-scored. Additionally, there are separate scores for family friction, appetite, and self-assessed survival quality. The scale covers four domains: physical health, psychological health, social relationships, and environment. Participants rate their experiences over the past two weeks. Each domain score is calculated by summing the relevant item scores and standardizing them, yielding a range from 0 to 100, with higher scores indicating better quality of life.
Measured: After the four-week intervention
Secondary outcomes (1)
general characteristics
Index: Gender, Age (years), BMI/ (kg/m2), Degree of education, History of diabetes, History of high blood pressure.
Measured: At the time of patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start10 Jan 2022
- Primary completion15 Feb 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yang Huang
- Sponsor type
- Other government
- Collaborators
- The Affiliated Brain Hospital of Nanjing Medical University
- Responsible party
- Sponsor-investigator, Yang Huang, The Affiliated Brain Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713395
- Sponsor's protocol ID
- 2020-KY091-01
- Acronym
- Glioma
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effects of PERMA-Based Integrated Psychological Intervention on Negative Emotions, Treatment Adherence, and Complications in Postoperative Glioma Patients
- ClinicalTrials.gov ID
- NCT06713395
- Acronym / sponsor ID
- Glioma / 2020-KY091-01
- Conditions
- Glioma
- Keywords
- PERMA, Glioma, Integrated psychological intervention, SAS, SDS, complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Yang HuangOther government
- Collaborators
- The Affiliated Brain Hospital of Nanjing Medical University
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether a PERMA-based integrated psychological intervention can reduce negative emotions, enhance treatment adherence, and decrease the risk of complications in postoperative glioma patients.
The main questions it aims to answer are:
Can the PERMA-based psychological intervention significantly improve anxiety and depression scores in postoperative glioma patients? Does the intervention improve treatment adherence, reduce complications, and enhance quality of life compared to standard care? Researchers will compare an observation group receiving the PERMA-based psychological intervention to a control group receiving standard postoperative care to see if the intervention improves patient outcomes.
Participants will:
Receive either standard postoperative care (control group) or PERMA-based psychological intervention for one month (observation group).
Be assessed on:
Self-Rating Depression Scale (SDS) and Self-Rating Anxiety Scale (SAS). Treatment Adherence Scale and Complication Record Form. Quality of Life Scale. Be followed for complications using Kaplan-Meier survival analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: The control group received standard postoperative careThe control group was provided with standard postoperative care |
| observation group | Other | Other: PERMAThe observation group received an additional PERMA-based integrated psychological intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ①Meeting the relevant diagnostic criteria from the 5th edition of the World Health Organization Classification of Central Nervous System (CNS) Tumors, and confirmed through postoperative pathological examination;
- ②Underwent surgical treatment;
- ③Clear consciousness, with good communication ability, and capable of cooperating with healthcare personnel to complete the study;
- ④Complete clinical data.
Key exclusion criteria (5 listed)
- ①Concurrent diagnosis of other malignant tumors;
- ②Coexisting cognitive impairment or other psychiatric disorders;
- ③Combined liver or kidney dysfunction, immune system disorders, or other severe diseases;
- ④Presence of infectious diseases;
- ⑤Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The control group received standard postoperative carestandard postoperative care | Other | control group |
| PERMA1. Establishment of the Integrated Psychological Intervention Team: The team consisted of 2 primary nurses, 4 specialist nurses, 1 psychologist, 2 physicians at the attending level or higher, and 2 researchers. Team Responsibilities: The primary and specialist nurses were responsible for implementing the intervention protocol. The physicians handled any adverse reactions experienced by the patients. The researchers were in charge of developing the intervention protocol and collecting data. All team members were required to undergo specialized training from the psychologist and pass an assessment before initiating the intervention. 2. Protocol Development: The intervention protocol, including specific content, team responsibilities, implementation process, and responses to adverse events, was carefully developed in written form by the researchers. The protocol was discussed and approved by all team members before implementation. 3. Protocol Implementation: Emotional Support Intervention: | Other | observation group |
Primary outcome
SAS score
Time frame: After the four-week intervention
Self-rating anxiety scale is a widely used psychological assessment tool designed to evaluate an individual's level of anxiety. There are 20 things on the scale, and a score of 100 is the total, assessing various anxiety-related emotions experienced by the participant over the past week. Each item is rated on a 4-point Likert scale, ranging from "no anxiety" to "extremely severe anxiety," where higher scores indicate more severe anxiety. Prior to and one month following the intervention, the SAS scores for each group were documented.
SDS score
Time frame: After the four-week intervention
Self-rating depression scale is a commonly used psychological assessment tool designed to evaluate an individual's level of depression. The scale typically consists of 20 items, with a total score of 100, covering various aspects of depression. Using a 4-point Likert scale that goes from "no depression" to "extremely severe depression," participants describe their moods over the course of the previous week. Higher scores signify more severe depression. The SDS scores for both groups were recorded before and one month after the intervention.
treatment adherence
Time frame: After the four-week intervention
Complete adherence: The patient actively cooperated with the medical and nursing staff, followed all prescribed treatments and interventions, and complied with medication, examinations, and other medical recommendations on a daily basis. Partial adherence: The patient generally cooperated with the medical and nursing staff but may not have fully adhered to all instructions. Non-adherence: The patient showed poor cooperation, requiring multiple reminders and explanations to comply with treatment protocols. The adherence rate was calculated as the sum of the complete and partial adherence rates. Adherence was recorded one month after the intervention.
Incidence of postoperative complications
Time frame: During the four-week intervention
The World Health Organization Quality of Life Brief Scale scores
Time frame: After the four-week intervention
WHOQOL-BREF is a tool used to assess an individual's quality of life. This scale consists of 26 items, each with five options, rated from 1 to 5, with higher scores reflecting better outcomes (or from very satisfied to extremely dissatisfied). However, items 3, 4, and 26 are reverse-scored. Additionally, there are separate scores for family friction, appetite, and self-assessed survival quality. The scale covers four domains: physical health, psychological health, social relationships, and environment. Participants rate their experiences over the past two weeks. Each domain score is calculated by summing the relevant item scores and standardizing them, yielding a range from 0 to 100, with higher scores indicating better quality of life.
1 secondary outcome
general characteristics
Time frame: At the time of patient enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
Related trials for Glioma
Active, not recruitingPhase 2
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma
Anaplastic Astrocytoma, Anaplastic Astrocytoma, Not Otherwise Specified
RecruitingObservational study
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
Glioblastoma Multiforme
RecruitingObservational study
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
Active, not recruitingPhase 2
Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
Glioblastoma Multiforme
RecruitingPhase 4
Dabrafenib and/or Trametinib Rollover Study
Melanoma, Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PERMA in people with Glioma, run by Yang Huang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAS score (time frame: After the four-week intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.