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CompletedNCT02471339Updated Jun 14, 2022Results posted

Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain

A Phase 3 interventional study of Acceptance and Commitment Therapy (ACT) in Neurofibromatosis Type 1 and Plexiform Neurofibromas, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 16 Years to 59 Years. Per ClinicalTrials.gov, last updated 2022-06-14.

Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
16 Years to 59 Years
Sex
All
01

Study 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.
Read the detailed description

BACKGROUND:

  • Neurofibromatosis type 1 (NF1) is a genetic disorder that affects approximately 1 in 3,500 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 person's pain, but to optimize the person's 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 2.0 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 training/educational 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.
02

Conditions studied

  • Neurofibromatosis Type 1
  • Plexiform Neurofibromas

Keywords

  • Psychological Intervention
  • Coping
  • Mindfulness
  • Randomized
03

In context

Neurofibromatosis 1

176 studies on the registry are indexed under Neurofibromatosis 1; 43 are open to participants now.

This study's enrollment of 66 is above the median of 35 across 114 interventional studies indexed under Neurofibromatosis 1.

Browse Neurofibromatosis 1 studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Browse National Cancer Institute (NCI) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.

    1. 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):

      • Six or more cafe-au-lait spots (greater than or equal to 0.5 cm in prepubertal subjects or greater than or equal to 1.5 cm in postpubertal subjects)
      • Greater than or equal to 2 neurofibromas or 1 plexiform neurofibroma
      • Freckling in the axilla or groin
      • Optic glioma
      • Two or more Lisch nodules
      • A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)
      • A first-degree relative with NF1
    2. Participants must have documentation of a plexiform neurofibromas (PN), based on either clinical exam or imaging.
    3. 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).
    4. Patients must have regular access to a computer or tablet with internet access.
    5. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written document.
    6. 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.
    7. 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

EXCLUSION CRITERIA FOR PARTICIPANT

  1. In the opinion of the Principal Investigator (PI) or an Associate Investigator (AI), the subject has significant cognitive or emotional difficulties that would prevent them from being able to understand and/or participate fully in the intervention or the measures.
  2. Subjects who are participating in any other treatment studies, either medical or behavioral, specifically for pain management.
  3. Subjects who began a medical intervention for treatment of their disease that has a possible impact on pain (including Mitogen-activated Protein/Extracellular Signal-regulated Kinase Kinase (MEK) trials) will not be eligible until after one year on the medical treatment; at that time, eligibility will be discussed with the PI of the medical study to assess the stability of the patient s pain and whether further pain-related changes due to the medical treatment are likely.
  4. Inability to travel to the NIH, for example, due to physical limitations, for the in-person evaluation(s).

No groups in regards to gender, race, or ethnicity are being excluded from participation in the trial.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    1/Acceptance and Commitment Therapy (ACT) Group

    2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats.

    Behavioral: Acceptance and Commitment Therapy (ACT)

  • Active comparator
    2/Waitlist (WL) Group

    Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1)

    Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

  • BehavioralAcceptance 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 8 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline and 8 weeks

  2. 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).

    Time frame: Baseline and 8 weeks

  3. 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.

    Time frame: Baseline and 8 weeks

  4. 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.

    Time frame: Baseline and 8 weeks

  5. 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.

    Time frame: Baseline and 8 weeks

  6. 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.

    Time frame: Baseline and 8 weeks

  7. 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.

    Time frame: Baseline and 8 weeks

  8. 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.

    Time frame: Baseline and 8 weeks

  9. 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).

    Time frame: Baseline and 8 weeks

Other outcomes

  1. 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.

    Time frame: Baseline, and Week 8, 16, 32, and 40.

07

Results

Posted Dec 6, 2021

Participant flow

Participant flow — Overall Study
Milestone1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Started3234
Completed3034
Not completed20
Withdrew: Did not provide follow-up data20

Outcome measures

PrimaryMean 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.

Time frame:
Baseline and 8 weeks
Reported as:
Mean · score on a scale
Mean Pain Interference Mean Score Change From Baseline to 8 Weeks Between the Acceptance and Commitment Therapy Intervention Group and the Waitlist Group
score on a scale1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Baseline61.93 ± 5.962.87 ± 5.9
8 weeks56.89 ± 6.461.21 ± 6.7
Statistical analysis
  • 1/Acceptance and Commitment Therapy (ACT) Group vs 2/Waitlist (WL) Group · ANCOVA · p = 0.05
SecondaryChange 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.

Time frame:
Baseline and 8 weeks
Reported as:
Mean · score on a scale
Change in Quality of Life (QOL) for Physical Functioning
score on a scale1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Baseline37.97 ± 19.438.17 ± 21.9
8 weeks42.39 ± 21.947.70 ± 25.5
Statistical analysis
  • 1/Acceptance and Commitment Therapy (ACT) Group vs 2/Waitlist (WL) Group · ANCOVA · p = 0.05
SecondaryMean 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).

Time frame:
Baseline and 8 weeks
Reported as:
Mean · score on a scale
Mean Pain Acceptance Pre- and Post-treatment
score on a scale1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Baseline58.78 ± 14.955.60 ± 14.8
8 Weeks71.91 ± 15.758.07 ± 15.9
SecondaryChange 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.

Time frame:
Baseline and 8 weeks
Reported as:
Mean · score on a scale
Change in Disease-related Pain Severity and Overall Tumor Pain
score on a scale1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Baseline disease-related pain severity7.52 ± 1.87.39 ± 1.6
8 weeks disease-related pain severity6.8 ± 2.66.97 ± 2.5
Baseline overall tumor pain7.53 ± 1.767.03 ± 2.58
8 weeks overall tumor pain6.81 ± 2.565.87 ± 2.62
SecondaryChange 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.

Time frame:
Baseline and 8 weeks
Reported as:
Mean · score on a scale
Change in Quality of Life (QOL) for Daily Activities
score on a scale1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Baseline84.3 ± 13.680.5 ± 14.7
8 weeks87.2 ± 12.880.4 ± 20.2
Statistical analysis
  • 1/Acceptance and Commitment Therapy (ACT) Group · t-test · p = .05
SecondaryChange 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.

Time frame:
Baseline and 8 weeks
Reported as:
Mean · score on a scale
Change in Disease-related Depression
score on a scale1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Baseline21.88 ± 12.325.40 ± 12.5
8 weeks18.47 ± 10.522.53 ± 11.9
SecondaryChange 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.

Time frame:
Baseline and 8 weeks
Reported as:
Mean · score on a scale
Change in Pain-related Anxiety
score on a scale1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Baseline52.44 ± 20.652.57 ± 21.5
8 weeks42.4 ± 22.345.37 ± 20.7
SecondaryChange 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.

Time frame:
Baseline and 8 weeks
Reported as:
Mean · milliseconds
Change in Heart Rate Variability (HRV)
milliseconds1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Baseline68.63 ± 64.894.74 ± 119.4
8 weeks88.11 ± 88.082.00 ± 99.8
SecondaryPain 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.

Time frame:
Baseline and 8 weeks
Reported as:
Mean · T-scores
Pain Interference Patient-Reported Outcomes Measurement Information System (PROMIS) II
T-scores1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Adult & Pediatric - Baseline61.9 ± 4.962.9 ± 5.9
Adult & Pediatric - 8 weeks56.9 ± 6.461.2 ± 6.9
Statistical analysis
  • 1/Acceptance and Commitment Therapy (ACT) Group vs 2/Waitlist (WL) Group · ANOVA · p = 0.042
SecondaryMeasure 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).

Time frame:
Baseline and 8 weeks
Reported as:
Mean · score on a scale
Measure of Pain Inflexibility Pre- and Post-treatment
score on a scale1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Baseline48.63 ± 14.851.53 ± 14.5
8 weeks40.10 ± 13.849.13 ± 16.9
Other pre-specifiedNumber 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.

Time frame:
Baseline, and Week 8, 16, 32, and 40.
Reported as:
Count of participants · Participants
Number of Participants With Serious and/or Non-serious Adverse Events
Participants1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) Group
Baseline00
Week 800
Week 1600
Week 3200
Week 4000

Adverse events

Collected over Baseline, Week 8, 16, 32, and 40.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1/Acceptance and Commitment Therapy (ACT) Group0/32 (0%)0/32 (0%)0/32 (0%)
2/Waitlist (WL) Group0/34 (0%)0/34 (0%)0/34 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) GroupTotal
<=18 years336
Between 18 and 65 years293160
>=65 years000
Age, Continuous
Age, Continuous(years)1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) GroupTotal
Mean31.09 ± 11.7428.88 ± 10.3529.98 ± 11.04
Sex: Female, Male
Sex: Female, Male(Participants)1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) GroupTotal
Female231740
Male91726
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) GroupTotal
Hispanic or Latino235
Not Hispanic or Latino282957
Unknown or Not Reported224
Race (NIH/OMB)
Race (NIH/OMB)(Participants)1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) GroupTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American369
White232245
More than one race224
Unknown or Not Reported347
Region of Enrollment
Region of Enrollment(participants)1/Acceptance and Commitment Therapy (ACT) Group2/Waitlist (WL) GroupTotal
United States323466
08

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — 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).

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: The protocol, SAP, and data will be shared when published on clinicaltrials.gov indefinitely.

Access criteria: http://yoda.yale.edu/

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02471339
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Staci Peron, Ph.D. (Principal Investigator, National Cancer Institute (NCI)) — Principal investigator
First posted
Jun 15, 2015
Start date
Jul 7, 2015
Primary completion
Dec 23, 2020
Completion
Dec 23, 2020
Results posted
Dec 6, 2021
Last update
Jun 14, 2022

Study contacts

Staci M Peron, Ph.D.
principal investigator · National Cancer Institute (NCI)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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