Self-Management Interventions for Chronic Pain Relief With Cancer Survivors

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Recorded Relaxation Intervention; Behavioral: Recorded Hypnosis Intervention

• Registration Number: NCT03867760
• Lead Sponsor: University of Washington

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 Timeline

• Study Start: 2019-02-21
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-08
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Results First Submitted: 2022-08-18
• Results First Submitted QC: 2022-09-28
• Status Verified: 2022-10
• Results First Posted: 2022-10-26
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention Control Group	Recorded Relaxation Intervention	Participants will use a recorded relaxation intervention at home for 28 days.
Intervention Group	Recorded Hypnosis Intervention	Participants will use the recorded hypnosis intervention (RHI) at home for 28 days.

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity	Pre- to Post-treatment (4 weeks)	The Patient Reported Outcomes Measurement Information System® (PROMIS®) v.1.0, 1a - Pain Intensity; minimum value 0, maximum value 10; a lower score indicates a better outcome. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.

Secondary Outcome Measures

Name	Time	Method
Change in Depression	Pre- to Post-treatment (4 weeks)	The Patient Reported Outcomes Measurement Information System® (PROMIS®) Depression Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less depression. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Change in Fatigue	Pre- to Post-treatment (4 weeks)	The Patient Reported Outcomes Measurement Information System® (PROMIS®) Fatigue Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less fatigue. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Change in Sleep Disturbance	Pre- to Post-treatment (4 weeks)	The Patient Reported Outcomes Measurement Information System® (PROMIS®) Sleep Disturbance Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less sleep disturbance. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Change in Pain Interference	Pre- to Post-treatment (4 weeks)	The Patient Reported Outcomes Measurement Information System® (PROMIS®) Pain Interference Short Form 4v1.1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less pain interference. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Change in Anxiety	Pre- to Post-treatment (4 weeks)	The Patient Reported Outcomes Measurement Information System® (PROMIS®) Anxiety Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less anxiety. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.

Trial Locations

Locations (2)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States