Clinical trial NCT03558594: Hypnosis and Meditation for Cancer Pain
Official title: Hypnosis and Meditation for Cancer Pain Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Related to Cancer
Cancer of Head and Neck
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
First posted: 2018-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral: Self-Hypnosis Training

Behavioral: Mindfulness Meditation
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Self-Reported Pain Intensity from Pre to post-treatment
timeFrame: Baseline and 4 weeks post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Heathcare System
state: Washington
Study officials:
References: