Hypnosis and Meditation for Cancer Pain

Cancer of Head and Neck Clinical Trial

Official title:

Hypnosis and Meditation for Cancer Pain Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03558594
• Other study ID #: 01670
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2018
• Est. completion date: July 28, 2020

Study information

• Verified date: August 2019
• Source: VA Puget Sound Health Care System
• Contact: Carrie Kincaid, BA
• Phone: 206-277-3959
• Email: carrie.kincaid[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Cancer Pain
• Head and Neck Neoplasms
• Pain Related to Cancer

Intervention

Behavioral:
• Hypnosis
Behavioral Condition
• Mindfulness
Behavioral Condition

Locations

Country	Name	City	State
United States	VA Puget Sound Heathcare System	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-Reported Pain Intensity from Pre to post-treatment	0-10 numeric scale	Baseline and 4 weeks post-baseline