Cancer of Head and Neck Clinical Trial
Official title:
Hypnosis and Meditation for Cancer Pain Pilot Study
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.
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.
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