Hypnosis and Meditation for Cancer Pain

• ClinicalTrials.gov Identifier: NCT03558594
• Recruitment Status: Unknown
• First Posted: June 15, 2018
• Last Update Posted: August 28, 2019
• Sponsor: VA Puget Sound Health Care System
• Information provided by (Responsible Party): Rhonda Williams, PhD, VA Puget Sound Health Care System

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.

Condition or disease	Intervention/treatment	Phase
Pain Related to Cancer; Cancer of Head and Neck	Behavioral: Hypnosis; Behavioral: Mindfulness	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

Behavioral: Self-Hypnosis Training

Behavioral: Mindfulness Meditation

• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hypnosis and Meditation for Cancer Pain Pilot Study
• Actual Study Start Date: July 31, 2018
• Estimated Primary Completion Date: July 28, 2020
• Estimated Study Completion Date: July 28, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hypnosis; 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).	Behavioral: Hypnosis; Behavioral Condition
Experimental: Mindfulness; 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.	Behavioral: Mindfulness; Behavioral Condition
No Intervention: No intervention; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Self-Reported Pain Intensity from Pre to post-treatment [ Time Frame: Baseline and 4 weeks post-baseline ]
   0-10 numeric scale

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Carrie Kincaid, BA; 206-277-3959; carrie.kincaid@va.gov

Locations

United States, Washington

VA Puget Sound Heathcare System; Recruiting

Seattle, Washington, United States, 98108

Contact: Carrie Kincaid

Sponsors and Collaborators

VA Puget Sound Health Care System

More Information

• Responsible Party: Rhonda Williams, PhD, Principal Investigator, VA Puget Sound Health Care System
• ClinicalTrials.gov Identifier: NCT03558594
• Other Study ID Numbers: 01670
• First Posted: June 15, 2018
• Last Update Posted: August 28, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Head and Neck Neoplasms; Cancer Pain; Pain; Neurologic Manifestations; Neoplasms by Site; Neoplasms