Pilot Test of a Pain Management Intervention Preparatory to a Future Pragmatic Trial (ASCENT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Feasibility of Intervention
研究概览
简要总结
This clinical trial tests how well a pain management intervention preparatory to a future pragmatic trial works in rural dwelling and Hispanic cancer survivors. Cancer pain is a key case study in health disparities in the United States. Cancer pain is prevalent, under treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Additionally, Hispanics not only comprise a steadily growing proportion of cancer survivors, but are also increasingly immigrating to rural communities, potentially placing them at "double risk" for poor outcomes. This trial will allow for the refinement of pain management intervention components that could help the management of cancer-related pain in rural dwelling and Hispanic cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. To refine and pilot test components of a validated collaborative care model-based intervention aimed at improving pain control among rural dwelling and Hispanic cancer survivors.
GROUP I: Participants meet with pain care manager (PCM) and community health worker (CHW) via telephone or video visit to discuss the cancer-related pain. Participants receive self-guided pain management education materials and receive an action plan with suggestions or referrals to participate in tier 1 interventions that include exercise, cognitive behavioral therapy, medication and/or tier 2 interventions that include integrative medicine (massage, acupuncture and mindfulness relaxation), spiritual support, pain clinic referral and palliative and spiritual care referrals during the intake visit. Participants undergo a planning visit 2 weeks later to give an update on their pain and may receive additional resources from the PCM and/or CHW. Participants then undergo a final visit 4 weeks later with the PCM and/or CHW and receive final recommendations and referrals. Participants may receive a follow up call between intake and visit 2 and/or between visit 2 and the final visit from the CHW or PCM to assess pain levels on study.
GROUP II: ASCENT study interventionists complete an interview on study.
GROUP III: Medical oncology providers participate in a focus group on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
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
- •A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site
- •Numerical rating scale (NRS) pain score of a 5+ out of 10
- •Pain that developed (onset) or significantly worsened since cancer diagnosis
- •Malignant hematology including:
- •Chronic leukemias
排除标准
- •Patient Health Questionnaire (PHQ) 8 score of 10 or more
- •Life expectancy less than 12 months
- •Hospice enrollment
- •Admitted to hospital from long term care/skilled nursing facilities (SNF)
- •Acute leukemias
- •Primary brain tumors
- •Confinement to a bed or a chair more than a third of waking hours because of health complications
研究组 & 干预措施
Group I (Pain management)
See detailed description.
干预措施: Acupuncture Therapy (Procedure)
Group I (Pain management)
See detailed description.
干预措施: Cancer Pain Management (Behavioral)
Group I (Pain management)
See detailed description.
干预措施: Cognitive Behavior Therapy (Behavioral)
Group I (Pain management)
See detailed description.
干预措施: Educational Intervention (Other)
Group I (Pain management)
See detailed description.
干预措施: Exercise (Other)
Group I (Pain management)
See detailed description.
干预措施: Interview (Other)
Group I (Pain management)
See detailed description.
干预措施: Massage Therapy (Procedure)
Group I (Pain management)
See detailed description.
干预措施: Mindfulness Relaxation (Behavioral)
Group I (Pain management)
See detailed description.
干预措施: Pain Therapy (Procedure)
Group I (Pain management)
See detailed description.
干预措施: Palliative Therapy (Other)
Group I (Pain management)
See detailed description.
干预措施: Patient Navigation (Behavioral)
Group I (Pain management)
See detailed description.
干预措施: Referral (Other)
Group I (Pain management)
See detailed description.
干预措施: Spiritual Therapy (Procedure)
Group I (Pain management)
See detailed description.
干预措施: Spiritual Care Referral (Procedure)
Group I (Pain management)
See detailed description.
干预措施: Survey Administration (Other)
Group II (Interview)
ASCENT study interventionists complete an interview on study.
干预措施: Interview (Other)
Group III (Focus group)
Medical oncology providers participate in a focus group on study.
干预措施: Discussion (Procedure)
结局指标
主要结局
Feasibility of Intervention
时间窗: Up to 60 days
Assessed by proportion of participants who received key intervention components.
Acceptability of Intervention - Interaction
时间窗: Up to 60 days
As assessed by frequency of participant interaction with care team.
Acceptability of Intervention - Satisfaction
时间窗: Up to 60 days
As assessed by participant satisfaction with care team interactions
Utility of Intervention - Helpfulness
时间窗: Up to 60 days
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful.
Utility of Intervention - Confidence
时间窗: Up to 60 days
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all confident and 5 = extremely confident.
Utility of Intervention - Ease
时间窗: Up to 60 days
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy.
次要结局
未报告次要终点