Self-Management Interventions for Chronic Pain Relief With Cancer Survivors
Efficacy and Mechanistic Testing of a Self-Management Intervention for Managing Chronic Pain With Cancer Survivors
4 other identifiers
interventional
109
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-pain
Started Feb 2019
Typical duration for not_applicable chronic-pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2019
CompletedFirst Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedResults Posted
Study results publicly available
October 26, 2022
CompletedNovember 17, 2022
October 1, 2022
2.5 years
March 4, 2019
August 18, 2022
October 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Pain Intensity
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.
Pre- to Post-treatment (4 weeks)
Secondary Outcomes (5)
Change in Pain Interference
Pre- to Post-treatment (4 weeks)
Change in Anxiety
Pre- to Post-treatment (4 weeks)
Change in Depression
Pre- to Post-treatment (4 weeks)
Change in Fatigue
Pre- to Post-treatment (4 weeks)
Change in Sleep Disturbance
Pre- to Post-treatment (4 weeks)
Other Outcomes (2)
Treatment Credibility and Expectancy
Pre-treatment
Change in Brain Activity
Baseline, 2 weeks, 4 weeks
Study Arms (2)
Intervention Group
EXPERIMENTALParticipants will use the recorded hypnosis intervention (RHI) at home for 28 days.
Attention Control Group
ACTIVE COMPARATORParticipants will use a recorded relaxation intervention at home for 28 days.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Illinois at Chicago
Chicago, Illinois, 60607, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Related Publications (1)
Eaton LH, Jang MK, Jensen MP, Pike KC, Heitkemper MM, Doorenbos AZ. Hypnosis and relaxation interventions for chronic pain management in cancer survivors: a randomized controlled trial. Support Care Cancer. 2022 Dec 17;31(1):50. doi: 10.1007/s00520-022-07498-1.
PMID: 36526937DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We were unable to conduct EEGs throughout the study period due to restrictions at the data collection site during the COVID pandemic.
Results Point of Contact
- Title
- Dr. Linda Eaton
- Organization
- University of Washington Bothell
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Eaton, RN
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 4, 2019
First Posted
March 8, 2019
Study Start
February 21, 2019
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
November 17, 2022
Results First Posted
October 26, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 8/31/21 - 8/31/24
- Access Criteria
- The data and associated documentation will be made available to users only under a data-sharing agreement that provides for (a) a commitment to using the data only for research purposes and not to identify any individual participant, (b) a commitment to securing the data using appropriate computer technology, and (c) a commitment to destroying or returning the data after analyses are completed. Such a data-use agreement will be executed through the PI. The database can then be accessed via a secure website, in a format that can be used by a variety of statistical software packages.
The proposed research will include data from adult cancer survivors with chronic pain. The final data set will include (1) qEEG pattern data, and (2) self-reported demographic and behavioral data from questionnaires and interviews. The final data set will be stripped of individual identifiers prior to release for sharing.