Ignite Creation Date:
2024-05-06 @ 7:08 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02471339
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2015-06-12
Brief Title:
Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1 Plexiform Neurofibromas and Chronic Pain
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1 Plexiform Neurofibromas and Chronic Pain A Phase III Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- People with neurofibromatosis type I NF1 and plexiform neurofibroma PN tumors often have chronic pain that his hard to control People usually take medicines for the pain but they may not work well and might cause side effects A new strategy called Acceptance and Commitment Training ACT may help these people cope with chronic pain ACT focuses on things like values and living in the moment
Objective
- To see if Acceptance and Commitment Training improves pain coping in people with NF1 pain
Eligibility
- People age 16-34 who have NF1 1 or more PN tumors and pain that interferes with their daily functioning
Design
Participants will be screened with a physical exam medical history and questions about their pain
Participants will fill out questionnaires about their pain and feelings Their heart rate will be measured via electrocardiogram ECG
Participants will be divided into 2 groups randomly One will wait 8 weeks
The other will start training right away
Participants will have 2 two-hour sessions with an ACT trainer They will learn techniques for setting goals based on personal values and other ways to cope with pain They will get a workbook and a compact disc CD to take home for practice
Participants will do practice exercises at home between sessions They will get weekly emails with a practice exercise They will join video chat sessions via home computer with their trainer
All participants will return to National Institutes of Health NIH after 8 weeks for questionnaires and an ECG The wait group will then start training They will return 8 weeks later for questionnaires and an ECG
Six months later they will complete questionnaires from home by computer
- People with neurofibromatosis type I NF1 and plexiform neurofibroma PN tumors often have chronic pain that his hard to control People usually take medicines for the pain but they may not work well and might cause side effects A new strategy called Acceptance and Commitment Training ACT may help these people cope with chronic pain ACT focuses on things like values and living in the moment
Objective
- To see if Acceptance and Commitment Training improves pain coping in people with NF1 pain
Eligibility
- People age 16-34 who have NF1 1 or more PN tumors and pain that interferes with their daily functioning
Design
Participants will be screened with a physical exam medical history and questions about their pain
Participants will fill out questionnaires about their pain and feelings Their heart rate will be measured via electrocardiogram ECG
Participants will be divided into 2 groups randomly One will wait 8 weeks
The other will start training right away
Participants will have 2 two-hour sessions with an ACT trainer They will learn techniques for setting goals based on personal values and other ways to cope with pain They will get a workbook and a compact disc CD to take home for practice
Participants will do practice exercises at home between sessions They will get weekly emails with a practice exercise They will join video chat sessions via home computer with their trainer
All participants will return to National Institutes of Health NIH after 8 weeks for questionnaires and an ECG The wait group will then start training They will return 8 weeks later for questionnaires and an ECG
Six months later they will complete questionnaires from home by computer
Detailed Description:
BACKGROUND
Neurofibromatosis type 1 NF1 is a genetic disorder that affects approximately 1 in 3500 individuals
A number of common clinical manifestations including plexiform neurofibromas can cause frequent and significant pain and impact quality of life
Often NF1-related pain is not well-controlled with medication and many of the medications cause significant side effects
To our knowledge only one prior study by our group has examined the effectiveness of a psychological intervention for chronic pain in adolescents and young adults AYA with NF1
Acceptance and Commitment Therapy ACT a newer generation of cognitive-behavioral therapy focuses on encouraging individuals to engage in more adaptive ways of coping with pain
The goal of ACT is not to eliminate the persons pain but to optimize the persons functioning despite their pain
OBJECTIVES
-To compare pain interference mean score changes from baseline to 8 weeks between the ACT intervention group and the waitlist WL group
ELIGIBILITY
Patients 16 - 59 years of age with a confirmed diagnosis of NF1 and greater than or equal to 1 plexiform neurofibroma PN
The patient must obtain a mean score of 20 or higher or a score of 3 on three or more items on the Pain Interference Index and report having pain that interferes with functioning for at least three months
The patient must have regular access to a computer or tablet with internet access
DESIGN
This is a psychological intervention study to determine the potential benefit of ACT on pain interference with patients randomized to the ACT intervention or a wait-list control group
Patients will come to the National Institutes of Health NIH for a 2-day visit Time 1 After baseline assessments questionnaires and ECG are completed participants in the ACT group will take part in two 2-hour ACT training sessions At home this group will receive weekly emails through week 8 and will participate in further ACT trainingeducational sessions via video chat at weeks 2 4 and 6
All patients will return to the NIH at week 8 Time 2 to complete follow-up questionnaires and ECG At this time the WL group will cross over and receive the ACT intervention in-person sessions weekly emails and video chat sessions All patients will complete questionnaires again from home six months following the completion of the intervention
To detect a change of 68 standard deviation on the primary outcome measure between the two groups at 80 power 41 patients per group are needed
Neurofibromatosis type 1 NF1 is a genetic disorder that affects approximately 1 in 3500 individuals
A number of common clinical manifestations including plexiform neurofibromas can cause frequent and significant pain and impact quality of life
Often NF1-related pain is not well-controlled with medication and many of the medications cause significant side effects
To our knowledge only one prior study by our group has examined the effectiveness of a psychological intervention for chronic pain in adolescents and young adults AYA with NF1
Acceptance and Commitment Therapy ACT a newer generation of cognitive-behavioral therapy focuses on encouraging individuals to engage in more adaptive ways of coping with pain
The goal of ACT is not to eliminate the persons pain but to optimize the persons functioning despite their pain
OBJECTIVES
-To compare pain interference mean score changes from baseline to 8 weeks between the ACT intervention group and the waitlist WL group
ELIGIBILITY
Patients 16 - 59 years of age with a confirmed diagnosis of NF1 and greater than or equal to 1 plexiform neurofibroma PN
The patient must obtain a mean score of 20 or higher or a score of 3 on three or more items on the Pain Interference Index and report having pain that interferes with functioning for at least three months
The patient must have regular access to a computer or tablet with internet access
DESIGN
This is a psychological intervention study to determine the potential benefit of ACT on pain interference with patients randomized to the ACT intervention or a wait-list control group
Patients will come to the National Institutes of Health NIH for a 2-day visit Time 1 After baseline assessments questionnaires and ECG are completed participants in the ACT group will take part in two 2-hour ACT training sessions At home this group will receive weekly emails through week 8 and will participate in further ACT trainingeducational sessions via video chat at weeks 2 4 and 6
All patients will return to the NIH at week 8 Time 2 to complete follow-up questionnaires and ECG At this time the WL group will cross over and receive the ACT intervention in-person sessions weekly emails and video chat sessions All patients will complete questionnaires again from home six months following the completion of the intervention
To detect a change of 68 standard deviation on the primary outcome measure between the two groups at 80 power 41 patients per group are needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-C-0142 | None | None | None |