Hypnosis for Pain Management With Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in pain and anxiety, as measured using the Pre- Post-Intervention Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Chronic pain is not cancer-related
研究组 & 干预措施
Group I (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.
干预措施: Hypnotherapy (Procedure)
Group I (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.
干预措施: Questionnaire Administration (Other)
Group II (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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in pain and anxiety, as measured using the Pre- Post-Intervention Questionnaire
时间窗: Baseline to up to 8 weeks
To evaluate the effects of the intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time, group) and 1 interaction effect (time X group). The interaction between group x time will show if the groups change differentially (whether intervention moderates change in outcome). Within the wait-list, O2 and O3 will be compared (paired t-test) to see if the wait-list replicates the immediate group's results. Within the immediate group, sustained effects of post-intervention results will be assessed by testing for
Change in pain-associated anxiety, measured using the Pain Catastrophizing Scale
时间窗: Up to 8 weeks
To evaluate effects of intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time and group) \& 1 interaction effect (time X group). Interaction between group x time will tell if groups change differentially (whether intervention moderates change in outcome). Within wait-list, O2 \& O3 will be compared (paired t-test) to see if wait-list replicates immediate group's results. Within immediate group, sustained effects of post-intervention results will be assessed by testing for change across time to O3. During
Change in Patient Reported Outcomes Measurement Information System-29 scores (measures function, anxiety, depression, fatigue, sleep, and pain interference and intensity)
时间窗: Baseline to up to 8 weeks
To evaluate the effects of the intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time, group) and 1 interaction effect (time X group). The interaction between group x time will show if the groups change differentially (whether intervention moderates change in outcome). Within the wait-list, O2 and O3 will be compared (paired t-test) to see if the wait-list replicates the immediate group's results. Within the immediate group, sustained effects of post-intervention results will be assessed by testing for
Feasibility of delivering hypnotherapy in terms of recruitment, attrition, adherence, and logistical issues
时间窗: Up to 12 months
A Consort flow diagram will be maintained to record the number of patients who were invited to participate in the study, number of patients who declined to participate and reasons why, number of patients who did not complete the study and reasons why, and adherence to using the intervention. Descriptive statistics (frequency counts, percentages) will be used to analyze the study recruitment, enrollment, and attrition data.
Patient demographics, as measured by the Demographic Questionnaire
时间窗: Baseline
Demographic variables will be analyzed using descriptive and inferential statistics. In order to examine variability and estimate effect sizes, the analysis needed in a larger trial will be modeled. Baseline demographic and dependent variables for the immediate and wait-list condition groups will be compared with Chi-square or independent t-tests.
Acceptability of hypnotherapy determined by structured phone interviews with participants
时间窗: At week 8
Transcribed interview data and open-ended responses from the pre- post-Intervention Questionnaire will be organized in ATLAS.ti. Content analysis will be used to understand the hypnosis experience. Consensus on key ideas and concepts will be obtained by the Lead Sub-Investigator and research assistant after reading and coding each transcript separately.
Change in beliefs on how well the treatment might work, as measured by the Credibility/Expectancy Questionnaire
时间窗: Baseline to up to 8 weeks
To evaluate the effects of the intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time, group) and 1 interaction effect (time X group). The interaction between group x time will show if the groups change differentially (whether intervention moderates change in outcome). Within the wait-list, O2 and O3 will be compared (paired t-test) to see if the wait-list replicates the immediate group's results. Within the immediate group, sustained effects of post-intervention results will be assessed by testing for
Change in imaginative involvement as measured by the Tellegen Absorption Scale
时间窗: Baseline to up to 8 weeks
To evaluate the effects of the intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time, group) and 1 interaction effect (time X group). The interaction between group x time will show if the groups change differentially (whether intervention moderates change in outcome). Within the wait-list, O2 and O3 will be compared (paired t-test) to see if the wait-list replicates the immediate group's results. Within the immediate group, sustained effects of post-intervention results will be assessed by testing for
Change in pain and anxiety, as measured using the patient diary
时间窗: Baseline to up to 8 weeks
To evaluate the effects of the intervention on efficacy endpoints, general linear modeling will be used. Participants will be a random effect. There will be 2 fixed effects (time, group) and 1 interaction effect (time X group). The interaction between group x time will show if the groups change differentially (whether intervention moderates change in outcome). Within the wait-list, O2 and O3 will be compared (paired t-test) to see if the wait-list replicates the immediate group's results. Within the immediate group, sustained effects of post-intervention results will be assessed by testing for
次要结局
未报告次要终点