Self-Management Interventions for Chronic Pain Relief With Cancer Survivors

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-21

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Group

Participants will use the recorded hypnosis intervention (RHI) at home for 28 days.

Group Type EXPERIMENTAL

Recorded Hypnosis Intervention

Intervention Type BEHAVIORAL

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.

Attention Control Group

Participants will use a recorded relaxation intervention at home for 28 days.

Group Type ACTIVE_COMPARATOR

Recorded Relaxation Intervention

Intervention Type BEHAVIORAL

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).

Interventions

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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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

* a history of seizure condition within the last year
* a significant brain injury or skull defect
* a history of brain cancer.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No