Clinical trial NCT02637297: Hypnotherapy in Treating Chronic Pain in Cancer Survivors
Official title: Hypnosis for Pain Management With Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Cancer Survivor
Chronic Pain
Depression
Sleep Disorder
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of Nursing Research (NINR)
name: American Nurses Foundation
First posted: 2015-12-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized pilot clinical trial studies hypnotherapy in treating chronic pain in cancer survivors. Hypnotherapy is a state of concentration and focused attention which can provide more control over the experience of acute and chronic pain and its impact and may provide comfort, maximize function, and improve quality of life in cancer survivors.

Detailed description: PRIMARY OBJECTIVES:

I. To test the feasibility (recruitment, attrition, adherence, logistical issues) of delivering the hypnosis (hypnotherapy) intervention to cancer survivors with chronic pain.

II. To evaluate the acceptability of the hypnosis intervention among cancer survivors with chronic pain.

III. To explore preliminary efficacy (estimate effect size) of hypnosis in relieving pain and improving associated anxiety and functional performance at 4 weeks and 8 weeks compared to a wait-list control.

OUTLINE: Participants are randomized to 1 of 2 groups.

IMMEDIATE INTERVENTION GROUP: Participants undergo hypnotherapy session over 20-30 minutes using a standardized script for pain reduction that contains post-hypnotic suggestions for permanence of hypnotherapy benefits. The hypnotherapy session is recorded and the participant listens to the recording daily for 4 weeks.

WAIT-LIST CONTROL GROUP: At week 5, participants undergo hypnotherapy session over 20-30 minutes using a standardized script for pain reduction that contains post-hypnotic suggestions for permanence of hypnotherapy benefits. The hypnotherapy session is recorded and the participant listens to the recording daily for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Self-report of moderate or higher pain on average during the last week (\> 3 on a 0-10 pain intensity numeric scale)
* Completed active cancer treatment other than maintenance therapy \>= 3 months ago
* Functional fluency in English
* Mentally and physically able to participate and complete surveys over the phone

Exclusion Criteria:

* Chronic pain is not cancer-related

Primary outcomes:
measure: Acceptability of hypnotherapy determined by structured phone interviews with participants
timeFrame: At week 8
measure: Change in beliefs on how well the treatment might work, as measured by the Credibility/Expectancy Questionnaire
timeFrame: Baseline to up to 8 weeks
measure: Change in imaginative involvement as measured by the Tellegen Absorption Scale
timeFrame: Baseline to up to 8 weeks
measure: Change in pain and anxiety, as measured using the patient diary
timeFrame: Baseline to up to 8 weeks
measure: Change in pain and anxiety, as measured using the Pre- Post-Intervention Questionnaire
timeFrame: Baseline to up to 8 weeks
measure: Change in pain-associated anxiety, measured using the Pain Catastrophizing Scale
timeFrame: Up to 8 weeks
measure: Change in Patient Reported Outcomes Measurement Information System-29 scores (measures function, anxiety, depression, fatigue, sleep, and pain interference and intensity)
timeFrame: Baseline to up to 8 weeks
measure: Feasibility of delivering hypnotherapy in terms of recruitment, attrition, adherence, and logistical issues
timeFrame: Up to 12 months
measure: Patient demographics, as measured by the Demographic Questionnaire
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Kathleen Shannon Dorcy
role: PRINCIPAL_INVESTIGATOR
References: