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Hypnosis and Meditation for Cancer Pain

Primary Purpose

Pain Related to Cancer, Cancer of Head and Neck

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypnosis
Mindfulness
Sponsored by
VA Puget Sound Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Related to Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Veteran status (defined as prior service in the US Armed Forces and eligible to receive health care services through Veterans Health Affairs)
  2. 18 years of age or older
  3. Undergoing head and/or neck cancer treatment at the VAPSHCS in Seattle.
  4. Less than two (2) errors on the 6-item Cognitive Screener
  5. Able to read, speak, and understand English

Exclusion Criteria:

  1. Primary psychotic or major thought disorder as listed in participant's medical record or self-reported
  2. Psychiatric or behavioral conditions in which symptoms were unstable or severe (e.g., current delirium, mania, psychosis, suicidal ideation, homicidal ideation, active substance use disorder, psychiatric hospitalization) as listed in participant's medical record or self-reported within the past six months
  3. Hospitalization for psychiatric reasons involving psychosis other than suicidal ideation, homicidal ideation, and/or PTSD as noted in chart (within the past 5 years).
  4. Difficulties or limitations communicating over the telephone

Sites / Locations

  • VA Puget Sound Heathcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Hypnosis

Mindfulness

No intervention

Arm Description

Participant will have one brief meeting with a clinician in which they will learn about hypnosis and be provided with an informational booklet and with audiorecordings of hypnosis exercises. Participants will be encouraged to listen to the hypnosis recordings as much as they would like, whenever they would like to listen. The recordings are short inductions followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the audio recordings that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality).

Participant will have one brief meeting with a clinician in which they will learn about mindfulness meditation and be provided with an informational booklet and with audio recordings of mindfulness exercises. Participants will learn Vipassana meditation by listening to audio recordings, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.Participants will be encouraged to listen to the meditation recordings as much as they would like, whenever they would like to listen.

Participants will enroll in the study, but do not select a study intervention. They will complete study assessments on the same schedule as those participants who select either experimental arm.

Outcomes

Primary Outcome Measures

Change in Self-Reported Pain Intensity from Pre to post-treatment
0-10 numeric scale

Secondary Outcome Measures

Full Information

First Posted
May 24, 2018
Last Updated
August 26, 2019
Sponsor
VA Puget Sound Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT03558594
Brief Title
Hypnosis and Meditation for Cancer Pain
Official Title
Hypnosis and Meditation for Cancer Pain Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
July 28, 2020 (Anticipated)
Study Completion Date
July 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Puget Sound Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The research study involves an open label trial (i.e., participant selects one of 2 interventions) to determine whether Veterans engaged in treatment for head and/or neck cancers find either of the two available behavioral treatments for pain (Self-Hypnosis or Mindfulness) helpful in managing pain, and if the study's delivery modality (providing audio recordings and workbooks for home use) is acceptable and feasible. If neither of the 2 interventions seems appealing, the participant can participate in the study by completing the study assessments only (this option is usual care); however, the participant will not receive the study materials or one-on-one appointments with the study clinician.
Detailed Description
At any given time, 2-8 Veterans are receiving treatment for head/neck cancer at VAPSHCS, which typically involves daily appointments over a period of 6-7 weeks. Some have tumor pain prior to treatment; many of those who do not have pain at the outset experience significant pain by week 3 of treatment. Individual clinical work with these Veterans using hypnosis and mindfulness interventions has been promising. The investigators will compare the efficacy of these two skills-based self-management approaches by looking at changes in pain and function from pre to post-treatment. This is an open label trial, so if there are sufficient participants who choose usual care, the investigators will also compare any pre-post changes to those subjects who elect usual care. Subjects will be up to 30 Veterans who are seeking treatment for head and/or neck cancer at VAPSHCS. Due to an open label model, the investigators anticipate that the treatment group size may be uneven. The investigators may find that participants select one intervention more than the others. The investigators have designed the intervention and measures in such a way as to minimize subject burden and to limit measures to those functional outcomes relevant to this population. The investigators will emphasize implementation aspects of the evaluation, measuring feasibility, relevance, and Veteran preferences. Knowledge generated from this study will include revealing treatment needs and preferred approaches to acute cancer pain management care for Veterans and demonstrating feasibility. The investigators anticipate that the findings will inform strategies to for making complementary meditation or self-hypnosis interventions available to Veterans dealing with cancer pain and pain related to cancer treatment. The investigators will learn if these interventions are feasible, acceptable, helpful and credible for Veterans undergoing active treatment for cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Related to Cancer, Cancer of Head and Neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Behavioral: Self-Hypnosis Training Behavioral: Mindfulness Meditation
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis
Arm Type
Experimental
Arm Description
Participant will have one brief meeting with a clinician in which they will learn about hypnosis and be provided with an informational booklet and with audiorecordings of hypnosis exercises. Participants will be encouraged to listen to the hypnosis recordings as much as they would like, whenever they would like to listen. The recordings are short inductions followed by therapeutic suggestions, including post-hypnotic suggestions. Participants will relax in a comfortable position with their eyes closed and will simply listen to the audio recordings that will include an induction followed by suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood and optimism, relaxation, sleep quality).
Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
Participant will have one brief meeting with a clinician in which they will learn about mindfulness meditation and be provided with an informational booklet and with audio recordings of mindfulness exercises. Participants will learn Vipassana meditation by listening to audio recordings, which is the specific form of mindfulness meditation (MM) typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.Participants will be encouraged to listen to the meditation recordings as much as they would like, whenever they would like to listen.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Participants will enroll in the study, but do not select a study intervention. They will complete study assessments on the same schedule as those participants who select either experimental arm.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
Behavioral Condition
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Behavioral Condition
Primary Outcome Measure Information:
Title
Change in Self-Reported Pain Intensity from Pre to post-treatment
Description
0-10 numeric scale
Time Frame
Baseline and 4 weeks post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veteran status (defined as prior service in the US Armed Forces and eligible to receive health care services through Veterans Health Affairs) 18 years of age or older Undergoing head and/or neck cancer treatment at the VAPSHCS in Seattle. Less than two (2) errors on the 6-item Cognitive Screener Able to read, speak, and understand English Exclusion Criteria: Primary psychotic or major thought disorder as listed in participant's medical record or self-reported Psychiatric or behavioral conditions in which symptoms were unstable or severe (e.g., current delirium, mania, psychosis, suicidal ideation, homicidal ideation, active substance use disorder, psychiatric hospitalization) as listed in participant's medical record or self-reported within the past six months Hospitalization for psychiatric reasons involving psychosis other than suicidal ideation, homicidal ideation, and/or PTSD as noted in chart (within the past 5 years). Difficulties or limitations communicating over the telephone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie Kincaid, BA
Phone
206-277-3959
Email
carrie.kincaid@va.gov
Facility Information:
Facility Name
VA Puget Sound Heathcare System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Kincaid

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypnosis and Meditation for Cancer Pain

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