Self-Management Interventions for Chronic Pain Relief With Cancer Survivors

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Behavioral: Recorded Hypnosis Intervention; Behavioral: Recorded Relaxation Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Controlled Trial
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Efficacy and Mechanistic Testing of a Self-Management Intervention for Managing Chronic Pain With Cancer Survivors
• Actual Study Start Date: February 21, 2019
• Estimated Primary Completion Date: February 21, 2021
• Estimated Study Completion Date: March 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Group; Participants will use the recorded hypnosis intervention (RHI) at home for 28 days.	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.
Active Comparator: Attention Control Group; Participants will use a recorded relaxation intervention at home for 28 days.	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).

Outcome Measures

Primary Outcome Measures :

1. Change in Pain Intensity [ Time Frame: Baseline, 2 weeks, 4 weeks ]
   PROMIS v.1.0 Pain Intensity 3a; lower score indicates better outcome

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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

Other Outcome Measures:

1. Change in Self-efficacy [ Time Frame: Baseline, 4 weeks ]
   PROMIS Self-Efficacy for Managing Symptoms; higher score indicates better outcome
2. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Linda Eaton, PhD; 425-352-3645; lineaton@uw.edu

Contact: Kari Jenssen, BS; 206-667-5262; kjenssen@fredhutch.org

Locations

United States, Washington

Seattle Cancer Care Alliance; Recruiting

Seattle, Washington, United States, 98109

Contact: Kari Jenssen, BS 206-667-5262 kjenssen@fredhutch.org

Sponsors and Collaborators

University of Washington

National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Linda Eaton, RN; University of Washington

  Study Documents (Full-Text)

Documents provided by Linda Eaton, University of Washington:

Study Protocol and Statistical Analysis Plan  [PDF] January 28, 2019

More Information

• Responsible Party: Linda Eaton, Assistant Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT03867760
• Other Study ID Numbers: STUDY00004809; NR017208-01A1 ( Other Grant/Funding Number: National Institute of Nursing Research )
• First Posted: March 8, 2019
• Last Update Posted: February 8, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations