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Self-Management Interventions for Chronic Pain Relief With Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03867760
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Linda Eaton, University of Washington

Tracking Information
First Submitted Date  ICMJE March 4, 2019
First Posted Date  ICMJE March 8, 2019
Last Update Posted Date March 4, 2021
Actual Study Start Date  ICMJE February 21, 2019
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
Change in Pain Intensity [ Time Frame: Baseline, 2 weeks, 4 weeks ]
PROMIS v.1.0 Pain Intensity 3a; lower score indicates better outcome
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Change in Pain Interference [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    PROMIS 29 v.1.0 (Measures 7 domains including pain interference); lower score indicates better outcome
  • Change in Anxiety [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    PROMIS 29 v.1.0 (Measures 7 domains including anxiety); lower score indicates better outcome
  • Change in Depression [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    PROMIS 29 v.1.0 (Measures 7 domains including depression); lower score indicates better outcome
  • Change in Fatigue [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    PROMIS 29 v.1.0 (Measures 7 domains including fatigue); lower score indicates better outcome
  • Change in Sleep Disturbance [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    PROMIS 29 v.1.0 (Measures 7 domains including sleep disturbance; lower score indicates better outcome
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 5, 2019)
  • Change in Self-efficacy [ Time Frame: Baseline, 4 weeks ]
    PROMIS Self-Efficacy for Managing Symptoms; higher score indicates better outcome
  • Change in Brain Activity [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    EEG measurement; measures brain activity while using study intervention (comparing study intervention to attention control)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Self-Management Interventions for Chronic Pain Relief With Cancer Survivors
Official Title  ICMJE Efficacy and Mechanistic Testing of a Self-Management Intervention for Managing Chronic Pain With Cancer Survivors
Brief Summary Cancer survivors who suffer from chronic pain would benefit from a low-cost, self-management intervention they can use at home. This study will evaluate the efficacy of a recorded hypnosis intervention in reducing chronic pain among cancer survivors and will explore its biological and psychological mechanisms.
Detailed Description

The purpose of this randomized controlled trial is to evaluate if a 4-week recorded hypnosis intervention (RHI) works for reducing chronic pain in 100 adult cancer survivors who have completed active treatment. The RHI will be compared to an attention control condition (relaxation recording). qEEG measurement will be obtained while listening to the RHI at weeks 0, 2, and 4 to explore if brain states are related to hypnotic analgesia during the 4-week study period in 20 study participants.

The study has the following specific aims:

Aim 1: Does the RHI work? Evaluate the efficacy of RHI in reducing self-reported pain intensity (primary outcome), pain interference, anxiety, depression, fatigue and sleep disturbance (secondary outcomes) at 4 weeks compared to the attention control condition (relaxation recording). Hypothesis: RHI will significantly reduce pain intensity, pain interference, anxiety, depression, fatigue, and sleep disturbance at 4 weeks.

Aim 2: For whom does the RHI work? Examine if psychological factors (hypnotic suggestibility, mental absorption, treatment outcome expectancy, fear of cancer recurrence, resilience, self-efficacy) influence the relationship between RHI and pain intensity at weeks 0, 2, and 4.

Aim 3: How does the RHI work? a. Compare brain activity as measured by electroencephalogram (EEG) in cancer survivors with chronic pain (n=30) receiving the RHI relative to the attention control condition (relaxation recording) at weeks 0, 2, and 4. b. Explore the effects of brain activity on pain intensity at weeks 0, 2, and 4. In addition, structured interviews will be conducted with participants to understand facilitators and barriers associated with undergoing EEG at three time points and perceptions on how the intervention works to reduce pain.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Behavioral: Recorded Hypnosis Intervention
    The RHI consists of four digital recordings developed by the investigator using standardized hypnosis scripts for pain reduction and uploaded to a MP3 player. The scripts were developed for patients with chronic pain and tested by a psychologist who is an expert in hypnosis research. Participants will listen to the recordings daily for 28 days in the prescribed order (4 recordings for 3 days each, and then any recording for the remaining 16 days). The script includes an induction, suggestions for how to access inner resources and manage pain, and post-hypnotic suggestions for permanence of hypnosis benefits and self-hypnosis practice.
  • Behavioral: Recorded Relaxation Intervention
    The recorded relaxation intervention consists of four digital recordings developed by the investigator using standardized relaxation scripts and uploaded to a MP3 player. Participants will listen to the recordings daily for 28 days in the prescribed order (4 recordings for 3 days each, and then any recording for the remaining 16 days).
Study Arms  ICMJE
  • Experimental: Intervention Group
    Participants will use the recorded hypnosis intervention (RHI) at home for 28 days.
    Intervention: Behavioral: Recorded Hypnosis Intervention
  • Active Comparator: Attention Control Group
    Participants will use a recorded relaxation intervention at home for 28 days.
    Intervention: Behavioral: Recorded Relaxation Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • self-reporting moderate or higher pain on average during the last week (> 3 on a 0-10 pain intensity numeric scale)
  • self-reporting experiencing pain at least half of the days in the past 4 weeks
  • self-reporting chronic pain related to cancer or its treatment
  • completed active cancer treatment other than maintenance therapy
  • being > 18 years of age
  • functional fluency in English
  • mentally and physically able to participate and complete surveys

Exclusion Criteria:

• has a psychiatric condition or symptoms (i.e., diagnosis of paranoid schizophrenia or active paranoid delusional thoughts, as determined via a telephone or in-person screening assessment) that would interfere with study participation.

Exclusion Criteria for Optional EEG Measurement:

  • a history of seizure condition within the last year
  • a significant brain injury or skull defect
  • a history of brain cancer.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Linda Eaton, PhD 425-352-3645 lineaton@uw.edu
Contact: Kari Jenssen, BS 206-667-5262 kjenssen@fredhutch.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03867760
Other Study ID Numbers  ICMJE STUDY00004809
5K23NR017208 ( U.S. NIH Grant/Contract )
RG1004569 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
NCI-2021-00201 ( Registry Identifier: NCI-CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The proposed research will include data from adult cancer survivors with chronic pain. The final data set will include (1) qEEG pattern data, and (2) self-reported demographic and behavioral data from questionnaires and interviews. The final data set will be stripped of individual identifiers prior to release for sharing.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 8/31/21 - 8/31/24
Access Criteria: The data and associated documentation will be made available to users only under a data-sharing agreement that provides for (a) a commitment to using the data only for research purposes and not to identify any individual participant, (b) a commitment to securing the data using appropriate computer technology, and (c) a commitment to destroying or returning the data after analyses are completed. Such a data-use agreement will be executed through the PI. The database can then be accessed via a secure website, in a format that can be used by a variety of statistical software packages.
Responsible Party Linda Eaton, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Linda Eaton, RN University of Washington
PRS Account University of Washington
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP