Clinical trial NCT03867760: Self-Management Interventions for Chronic Pain Relief With Cancer Survivors
Official title: Efficacy and Mechanistic Testing of a Self-Management Intervention for Managing Chronic Pain With Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-03-08
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: Pre- to Post-treatment (4 weeks)
Secondary outcomes:
measure: Change in Pain Interference
timeFrame: Pre- to Post-treatment (4 weeks)
measure: Change in Anxiety
timeFrame: Pre- to Post-treatment (4 weeks)
measure: Change in Depression
timeFrame: Pre- to Post-treatment (4 weeks)
measure: Change in Fatigue
timeFrame: Pre- to Post-treatment (4 weeks)
measure: Change in Sleep Disturbance
timeFrame: Pre- to Post-treatment (4 weeks)
Other outcomes:
measure: Treatment Credibility and Expectancy
timeFrame: Pre-treatment
measure: Change in Brain Activity
timeFrame: Baseline, 2 weeks, 4 weeks
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: University of Washington
name: Linda Eaton, RN
role: PRINCIPAL_INVESTIGATOR
References: