Self-Management Interventions for Chronic Pain Relief With Cancer Survivors
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

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.
    

Intervention name(s): Recorded Hypnosis Intervention; Recorded Relaxation Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Supportive Care