Chronic PainNCT03867760
Self-Management Interventions for Chronic Pain Relief With Cancer Survivors
A study testing Recorded Hypnosis Intervention and Recorded Relaxation Intervention in people with Chronic Pain, run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Recorded Hypnosis Intervention and Recorded Relaxation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Feb 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois at Chicago
Chicago, Illinois, 60607
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: Efficacy and Mechanistic Testing of a Self-Management Intervention for Managing Chronic Pain With Cancer Survivors
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Recorded Hypnosis Intervention, Recorded Relaxation Intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recorded Hypnosis InterventionBehavioural
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.
Recorded Relaxation InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will use the recorded hypnosis intervention (RHI) at home for 28 days. Receives: Behavioral: Recorded Hypnosis Intervention |
| Attention Control Group | Active comparator | Participants will use a recorded relaxation intervention at home for 28 days. Receives: Behavioral: Recorded Relaxation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre- to Post-treatment (4 weeks)
Secondary outcomes (5)
Change in Pain Interference
The Patient Reported Outcomes Measurement Information System® (PROMIS®) Pain Interference Short Form 4v1.1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less pain interference. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Measured: Pre- to Post-treatment (4 weeks)
Change in Anxiety
The Patient Reported Outcomes Measurement Information System® (PROMIS®) Anxiety Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less anxiety. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Measured: Pre- to Post-treatment (4 weeks)
Change in Depression
The Patient Reported Outcomes Measurement Information System® (PROMIS®) Depression Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less depression. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Measured: Pre- to Post-treatment (4 weeks)
Change in Fatigue
The Patient Reported Outcomes Measurement Information System® (PROMIS®) Fatigue Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less fatigue. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Measured: Pre- to Post-treatment (4 weeks)
Change in Sleep Disturbance
The Patient Reported Outcomes Measurement Information System® (PROMIS®) Sleep Disturbance Short Form 4v1 scores were converted to T-scores. T-scores of 50 indicates the U.S. population mean with a standard deviation of 10. A lower score indicates less sleep disturbance. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
Measured: Pre- to Post-treatment (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start21 Feb 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Linda Eaton, University of Washington
- Investigators
- Linda Eaton, RN, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867760
- Sponsor's protocol ID
- STUDY00004809
- Other IDs
- 5K23NR017208, RG1004569, NCI-2021-00201
- Status last verified
- Oct 2022
- First submitted
- 4 Mar 2019
- Last updated
- 17 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Eaton LH, Jang MK, Jensen MP, Heitkemper MM, Doorenbos AZ. Perceptions of the effects of recorded hypnosis and relaxation interventions for cancer survivors with chronic pain. Complement Ther Clin Pract. 2024 Nov;57:101907. doi: 10.1016/j.ctcp.2024.101907. Epub 2024 Sep 12.
PubMed 39284247Eaton 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.
PubMed 36526937
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanistic Testing of a Self-Management Intervention for Managing Chronic Pain With Cancer Survivors
- ClinicalTrials.gov ID
- NCT03867760
- Acronym / sponsor ID
- STUDY00004809
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Posted 26 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Recorded Hypnosis InterventionParticipants will use the recorded hypnosis intervention (RHI) at home for 28 days. |
| Attention Control Group | Active comparator | Behavioral: Recorded Relaxation InterventionParticipants will use a recorded relaxation intervention at home for 28 days. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recorded Hypnosis InterventionThe 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. | Behavioural | Intervention Group |
| Recorded Relaxation InterventionThe 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). | Behavioural | Attention Control Group |
Primary outcome
Change in Pain Intensity
Time frame: Pre- to Post-treatment (4 weeks)
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.
5 secondary outcomes
Change in Pain Interference
Time frame: Pre- to Post-treatment (4 weeks)
Change in Anxiety
Time frame: Pre- to Post-treatment (4 weeks)
Change in Depression
Time frame: Pre- to Post-treatment (4 weeks)
Change in Fatigue
Time frame: Pre- to Post-treatment (4 weeks)
Change in Sleep Disturbance
Time frame: Pre- to Post-treatment (4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39284247Eaton LH, Jang MK, Jensen MP, Heitkemper MM, Doorenbos AZ. Perceptions of the effects of recorded hypnosis and relaxation interventions for cancer survivors with chronic pain. Complement Ther Clin Pract. 2024 Nov;57:101907. doi: 10.1016/j.ctcp.2024.101907. Epub 2024 Sep 12.
- Derived from this study: PubMed 36526937Eaton 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Eaton, RN principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recorded Hypnosis Intervention and Recorded Relaxation Intervention in people with Chronic Pain, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Pre- to Post-treatment (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03867760, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.