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| ID | Type | Description | Link |
|---|---|---|---|
| 15-C-0142 |
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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:
BACKGROUND:
OBJECTIVES:
-To compare pain interference mean score changes from baseline to 8 weeks between the ACT intervention group and the waitlist (WL) group.
ELIGIBILITY:
DESIGN:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1/Acceptance and Commitment Therapy (ACT) Group | Experimental | 2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats. |
|
| 2/Waitlist (WL) Group | Active Comparator | Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Interference Mean Score Change From Baseline to 8 Weeks Between the Acceptance and Commitment Therapy Intervention Group and the Waitlist Group | Pain interference mean score changes were compared between the two groups from baseline to 8 weeks using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale.T-scores typically can range from 0 to 100, with "average" scores ranging from 41-59. No subscales are included in this measure. Higher scores indicate more pain interference (worse). A two-way repeated-measures analysis of covariance (ANCOVA) was used to examine changes between groups from baseline to the 8-week follow-up. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life (QOL) for Physical Functioning | Baseline to post-treatment changes in disease-related quality of life was assessed various aspects of quality of life using a subscale from the Pediatric Quality of Life Inventory (PedsQL) Neurofibromatosis Type 1 (NF) Module adult questionnaire which uses a 0-4 Likert scale (0= never, 4 = almost always). Physical Functioning (7 items; possible range 0-28) subscale was administered. Higher scores are worse. Mean scores are linearly transformed to a 0-100 scale, and then were compared to means and standard deviations of a normative group of patients with Neurofibromatosis Type 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events | Here is the number of participants with serious and non-serious adverse events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
INCLUSION CRITERIA FOR PARTICIPANT
Patients must be between 16 and 59 years of age at the time of the baseline assessment. Because the research on the effectiveness of Acceptance and Commitment Therapy (ACT) with younger children is still emerging, children 15 and younger will be excluded from the present study.
Diagnosis of Neurofibromatosis Type 1 (NF1) through germline mutation OR clinical diagnosis; for the clinical diagnosis of NF1 all study subjects must have two or more diagnostic criteria for NF1 listed below (National Institutes of Health (NIH) Consensus Conference):
Participants must have documentation of a plexiform neurofibromas (PN), based on either clinical exam or imaging.
Patient must self-report having chronic pain for at least the past 3 months that has interfered with their daily functioning, as assessed by the Pain Interference Index (must get a mean score of 2.0 or higher, or score a 3 on three or more individual items).
Patients must have regular access to a computer or tablet with internet access.
Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
No anticipated major changes in their pain treatment regimen (i.e., new class of pain medication starting or change in the class of pain medication) or enrollment on a new treatment study presumed to impact pain in the near future.
Subjects must be able to read and comprehend the English language, since the highly trained ACT therapists are not fluent enough to conduct the trainings in Spanish or other languages.
EXCLUSION CRITERIA FOR PARTICIPANT
No groups in regards to gender, race, or ethnicity are being excluded from participation in the trial.
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| Name | Affiliation | Role |
|---|---|---|
| Staci M Peron, Ph.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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The authors will make the data, protocol, and statistical plan available upon request. Also share raw data per researchers request to access the IPD via the online platform Yale University Open Data Access (YODA).
The protocol, SAP, and data will be shared when published on clinicaltrials.gov indefinitely.
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66/67 are enrolled on this study because one participant was deemed ineligible and taken off study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1/Acceptance and Commitment Therapy (ACT) Group | 2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats. Acceptance and Commitment Therapy (ACT): 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2019 |
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| Baseline and 8 weeks |
| Mean Pain Acceptance Pre- and Post-treatment | Measure of Pain Acceptance pre- and post-treatment was assessed by the Chronic Pain Acceptance Questionnaire (CPAQ) to determine if participants can accept his or her pain. Participants answer 20 questions on a 0 (never true) to 6 (always true) rating scale, with higher scores indicating higher levels of acceptance. Scores are obtained on two subscales (Activities Engagement and Pain Willingness) and an Acceptance Total scale. Only the total score was analyzed for this study. Scores can range from 0 to 120, with higher scores indicating more acceptance (better). | Baseline and 8 weeks |
| Change in Disease-related Pain Severity and Overall Tumor Pain | Pre and post changes in disease-related pain severity and overall tumor pain was assessed using the Numeric Rating Scale - 11 (NRS-11). Two questions rate pain severity on a scale of 0 (no pain) to 10 (worst pain imaginable). For both questions, higher scores = more pain. The two questions are examined separately, there is no total score across items. | Baseline and 8 weeks |
| Change in Quality of Life (QOL) for Daily Activities | Baseline to post-treatment changes in disease-related quality of life, including Daily Activities was assessed using a subscale from the Pediatric Quality of Life Inventory (PedsQL) Neurofibromatosis Type 1 (NF) Module adult questionnaire which uses a 0-4 Likert scale (0= never, 4 = almost always). Daily Activities (12 items; possible range 0-48) subscale was administered. Higher scores are worse. Mean scores are linearly transformed to a 0-100 scale, and then were compared to means and standard deviations of a normative group of patients with Neurofibromatosis Type 1. | Baseline and 8 weeks |
| Change in Disease-related Depression | Pre and post changes in disease-related depression was assessed using the 20-item Center for Epidemiological Studies - Depression scale (CES-D). Participants rate symptoms they have experienced in the past week and items are scored on a 0 (rare or none of the time) to 3 (most of all of the time) scale. Individual responses yield scores on four subscales: depressive affect, positive affect, somatic activity, and interpersonal. A total depression score is obtained that can range from 0 to 60, with higher scores representing worse depressive symptoms. | Baseline and 8 weeks |
| Change in Pain-related Anxiety | Pre and post changes in disease-related pain-related anxiety was assessed by the Pain Anxiety Assessment Scale - 20 (PASS-20). Items are answered on a 6-point Likert scale with anchors of "never" and "always" which provides a total score and scores on four subscales for Cognitive Anxiety, Pain-related Fear, Escape and Avoidance, and Physiological Anxiety. We only examined the total score on this measure, which can range from 0 to 100; higher scores indicate more anxiety. | Baseline and 8 weeks |
| Change in Heart Rate Variability (HRV) | Pre and post changes in disease-related HRV was assessed using an electrocardiogram (EKG). An EKG records electrical signals from your heart. The EKG reading will occur for 5 minutes while the patient is lying down and measurements, including the standard deviation of the average NN (normal-to-normal) interval (SDANN) and the square root of the mean squared differences of successive NN intervals is recorded, resulting in a metric of parasympathetically mediated (high frequency) HRV in milliseconds. | Baseline and 8 weeks |
| Pain Interference Patient-Reported Outcomes Measurement Information System (PROMIS) II | The psychometric properties of the pain interference measure PROMIS was administered to assess pain interference. And adult (18-59 years) and pediatric (16 -17 years) questionnaire was administered to assess how pain interferes with sleep, mood, and leisure activities for instance. Items were formatted on 0-4 Likert scales (0 = Never, 4 = Almost Always) and transformed to T-scores. The PROMIS Pain Interference Scale takes less than 5 minutes to complete and is required of all participants. T-scores typically range from the 20s to 80s with a mean of 50 and standard deviation of 10 ("average" scores range from 40 - 60). No subscales are included in this measure. Higher scores indicate more pain interference (worse). The pediatric and adult versions are made to be parallel so we analyzed all participants together across ages. A two-way repeated-measures analysis of variance (ANOVA) was used to examine changes between groups from baseline to the 8-week follow-up. | Baseline and 8 weeks |
| Measure of Pain Inflexibility Pre- and Post-treatment | Pre- and post-treatment pain interference was assessed using the 12-item Psychological Inflexibility in Pain Scale (PIPS). Participants rate their avoidance of activities because of their pain on a Likert scale of 1 (never true) to 7 (always true). Eight of the items are summed to yield a score on the Avoidance subscale, and four of the items are summed for the Fusion subscale. A total score also is obtained by summing all 12 items. We analyzed only the total score in this study, which can range from 12-84, with higher scores indicating more inflexibility (worse). | Baseline and 8 weeks |
| Baseline, and Week 8, 16, 32, and 40. |
| FG001 | 2/Waitlist (WL) Group | Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1) Acceptance and Commitment Therapy (ACT): 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1/Acceptance and Commitment Therapy (ACT) Group | 2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats. Acceptance and Commitment Therapy (ACT): 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. |
| BG001 | 2/Waitlist (WL) Group | Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1) Acceptance and Commitment Therapy (ACT): 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Pain Interference Mean Score Change From Baseline to 8 Weeks Between the Acceptance and Commitment Therapy Intervention Group and the Waitlist Group | Pain interference mean score changes were compared between the two groups from baseline to 8 weeks using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale.T-scores typically can range from 0 to 100, with "average" scores ranging from 41-59. No subscales are included in this measure. Higher scores indicate more pain interference (worse). A two-way repeated-measures analysis of covariance (ANCOVA) was used to examine changes between groups from baseline to the 8-week follow-up. | 30/34 were analyzed in the Waitlist group because 2 participants were withdrawn from final analyses due to medical contraindications identified immediately after the post-intervention follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life (QOL) for Physical Functioning | Baseline to post-treatment changes in disease-related quality of life was assessed various aspects of quality of life using a subscale from the Pediatric Quality of Life Inventory (PedsQL) Neurofibromatosis Type 1 (NF) Module adult questionnaire which uses a 0-4 Likert scale (0= never, 4 = almost always). Physical Functioning (7 items; possible range 0-28) subscale was administered. Higher scores are worse. Mean scores are linearly transformed to a 0-100 scale, and then were compared to means and standard deviations of a normative group of patients with Neurofibromatosis Type 1. | 30/34 were analyzed in the Waitlist group because 2 participants were withdrawn from final analyses due to medical contraindications identified immediately after the post-intervention follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Pain Acceptance Pre- and Post-treatment | Measure of Pain Acceptance pre- and post-treatment was assessed by the Chronic Pain Acceptance Questionnaire (CPAQ) to determine if participants can accept his or her pain. Participants answer 20 questions on a 0 (never true) to 6 (always true) rating scale, with higher scores indicating higher levels of acceptance. Scores are obtained on two subscales (Activities Engagement and Pain Willingness) and an Acceptance Total scale. Only the total score was analyzed for this study. Scores can range from 0 to 120, with higher scores indicating more acceptance (better). | 30/34 were analyzed in the Waitlist group because 2 participants were withdrawn from final analyses due to medical contraindications identified immediately after the post-intervention follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Disease-related Pain Severity and Overall Tumor Pain | Pre and post changes in disease-related pain severity and overall tumor pain was assessed using the Numeric Rating Scale - 11 (NRS-11). Two questions rate pain severity on a scale of 0 (no pain) to 10 (worst pain imaginable). For both questions, higher scores = more pain. The two questions are examined separately, there is no total score across items. | 30/34 were analyzed in the Waitlist group because 2 participants were withdrawn from final analyses due to medical contraindications identified immediately after the post-intervention follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life (QOL) for Daily Activities | Baseline to post-treatment changes in disease-related quality of life, including Daily Activities was assessed using a subscale from the Pediatric Quality of Life Inventory (PedsQL) Neurofibromatosis Type 1 (NF) Module adult questionnaire which uses a 0-4 Likert scale (0= never, 4 = almost always). Daily Activities (12 items; possible range 0-48) subscale was administered. Higher scores are worse. Mean scores are linearly transformed to a 0-100 scale, and then were compared to means and standard deviations of a normative group of patients with Neurofibromatosis Type 1. | 30/34 were analyzed in the Waitlist group because 2 participants were withdrawn from final analyses due to medical contraindications identified immediately after the post-intervention follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Disease-related Depression | Pre and post changes in disease-related depression was assessed using the 20-item Center for Epidemiological Studies - Depression scale (CES-D). Participants rate symptoms they have experienced in the past week and items are scored on a 0 (rare or none of the time) to 3 (most of all of the time) scale. Individual responses yield scores on four subscales: depressive affect, positive affect, somatic activity, and interpersonal. A total depression score is obtained that can range from 0 to 60, with higher scores representing worse depressive symptoms. | 30/34 were analyzed in the Waitlist group because 2 participants were withdrawn from final analyses due to medical contraindications identified immediately after the post-intervention follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Pain-related Anxiety | Pre and post changes in disease-related pain-related anxiety was assessed by the Pain Anxiety Assessment Scale - 20 (PASS-20). Items are answered on a 6-point Likert scale with anchors of "never" and "always" which provides a total score and scores on four subscales for Cognitive Anxiety, Pain-related Fear, Escape and Avoidance, and Physiological Anxiety. We only examined the total score on this measure, which can range from 0 to 100; higher scores indicate more anxiety. | 30/34 were analyzed in the Waitlist group because 2 participants were withdrawn from final analyses due to medical contraindications identified immediately after the post-intervention follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Heart Rate Variability (HRV) | Pre and post changes in disease-related HRV was assessed using an electrocardiogram (EKG). An EKG records electrical signals from your heart. The EKG reading will occur for 5 minutes while the patient is lying down and measurements, including the standard deviation of the average NN (normal-to-normal) interval (SDANN) and the square root of the mean squared differences of successive NN intervals is recorded, resulting in a metric of parasympathetically mediated (high frequency) HRV in milliseconds. | 30/34 were analyzed in the Waitlist group because 2 participants were withdrawn from final analyses due to medical contraindications identified immediately after the post-intervention follow-up. | Posted | Mean | Standard Deviation | milliseconds | Baseline and 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pain Interference Patient-Reported Outcomes Measurement Information System (PROMIS) II | The psychometric properties of the pain interference measure PROMIS was administered to assess pain interference. And adult (18-59 years) and pediatric (16 -17 years) questionnaire was administered to assess how pain interferes with sleep, mood, and leisure activities for instance. Items were formatted on 0-4 Likert scales (0 = Never, 4 = Almost Always) and transformed to T-scores. The PROMIS Pain Interference Scale takes less than 5 minutes to complete and is required of all participants. T-scores typically range from the 20s to 80s with a mean of 50 and standard deviation of 10 ("average" scores range from 40 - 60). No subscales are included in this measure. Higher scores indicate more pain interference (worse). The pediatric and adult versions are made to be parallel so we analyzed all participants together across ages. A two-way repeated-measures analysis of variance (ANOVA) was used to examine changes between groups from baseline to the 8-week follow-up. | Posted | Mean | Standard Deviation | T-scores | Baseline and 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measure of Pain Inflexibility Pre- and Post-treatment | Pre- and post-treatment pain interference was assessed using the 12-item Psychological Inflexibility in Pain Scale (PIPS). Participants rate their avoidance of activities because of their pain on a Likert scale of 1 (never true) to 7 (always true). Eight of the items are summed to yield a score on the Avoidance subscale, and four of the items are summed for the Fusion subscale. A total score also is obtained by summing all 12 items. We analyzed only the total score in this study, which can range from 12-84, with higher scores indicating more inflexibility (worse). | 30/34 were analyzed in the Waitlist group because 2 participants were withdrawn from final analyses due to medical contraindications identified immediately after the post-intervention follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Serious and/or Non-serious Adverse Events | Here is the number of participants with serious and non-serious adverse events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Per protocol - "adverse events occurring as a result of treatment for the underlying condition or medical treatment for pain will NOT be recorded or reported on this study." 30/34 were analyzed in the Waitlist group because 2 participants were withdrawn from final analyses due to medical contraindications identified immediately after the post-intervention follow-up. | Posted | Count of Participants | Participants | Baseline, and Week 8, 16, 32, and 40. |
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Baseline, Week 8, 16, 32, and 40.
Per protocol - "adverse events occurring as a result of treatment for the underlying condition or medical treatment for pain will NOT be recorded or reported on this study."
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1/Acceptance and Commitment Therapy (ACT) Group | 2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats. Acceptance and Commitment Therapy (ACT): 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. | 0 | 32 | 0 | 32 | 0 | 32 |
| EG001 | 2/Waitlist (WL) Group | Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1) Acceptance and Commitment Therapy (ACT): 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. | 0 | 34 | 0 | 34 | 0 | 34 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Staci M. Peron, Ph.D. | National Cancer Institute | 240-760-6025 | martins@mail.nih.gov |
| Jun 22, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent | Mar 5, 2019 | Jun 22, 2021 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Standard Consent | Mar 5, 2019 | Jun 22, 2021 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Screening Consent | Mar 5, 2019 | Jun 22, 2021 | ICF_003.pdf |
| ID | Term |
|---|---|
| D009456 | Neurofibromatosis 1 |
| D018318 | Neurofibroma, Plexiform |
| ID | Term |
|---|---|
| D017253 | Neurofibromatoses |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
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Not provided
| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1)
Acceptance and Commitment Therapy (ACT): 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.
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Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1) Acceptance and Commitment Therapy (ACT): 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. |
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