Hypnosis and Meditation for Cancer Pain

Phase

N/A

Condition

Cancer Pain

Acute Pain

Pain

Treatment

N/A

Clinical Study ID

NCT03558594

01670

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Veteran status (defined as prior service in the US Armed Forces and eligible toreceive 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

Exclusion Criteria:

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

Study Design

July 31, 2018

July 28, 2020

Study 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.

Connect with a study center

VA Puget Sound Heathcare System
Seattle, Washington 98108
United States
Active - Recruiting

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