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临床试验/NCT06461416
NCT06461416已完成不适用

Occupational Resilience: A Pilot Trial for a Preliminary Estimate of the Effectiveness of a Novel Theoretical Framework

University of Arkansas2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Occupational Resilience Measure (ORM 1.0)

研究概览

简要总结

  • Aim 1: To determine the preliminary effect sizes of al ActiveHeal EST (Engage-Sustain-Triumph) Program on occupational resilience.
  • Aim 2: To determine the preliminary effect sizes of ActiveHeal EST (Engage-Sustain-Triumph) on health status [quality of life (QoL) and Psychological wellbeing (PWB)].
  • Aim 3: To determine the extent to which ActiveHeal EST (Engage-Sustain-Triumph) Program is an acceptable and feasible Intervention for breast and prostate cancer survivors.

详细描述

The study will utilize the randomized study design with two groups of 15 participants each arm. The intervention group will receive occupational therapy services for 12 weeks. The control group will meet three times via zoom but not receive an intervention. All participants will have three assessments completed before and after the intervention. The experimental group will have a feasibility and acceptability survey at the end of the intervention.

Week 1-6 Recruitment, Informed Consent Process Commenced, and Randomization (Both Groups A & B) Week 7-8 Pretests: Administer Occupational Resilience Measure (ORM 1.0), World Health Organization Quality of Life Scale (WHOQOL BREF), and Psychological Wellbeing Scale. To be completed with participant via Zoom (Both Groups A & B) Week 9, 11, 15, &18 (Week 1, 2, 3, 4, 7, & 10 of the ActiveHeal EST (Engage-Sustain-Triumph)Program) Six Group ActiveHeal EST Sessions (Group A only). Each session is 75 minutes. It will include education on benefits of activity and strategies to make sustained performance possible (e.g., managing fatigue, pain, and edema), highlighting History, Experience, Benefits, and Adaptation (Location: Teams- Online). The group sessions will be led by the PI (or one of the trained occupational therapists who are familiar with the applied group and individual therapy process) and a student assistant to assist in the specified group activity performance. Although the intervention approach is specific, the use of activity as intervention is well understood by any certified occupational therapist. The training will therefore focus on what the sessions look like if these four factors are the guide to group or individual intervention, and a review of occupational therapy best practices for adults with cancer. Three additional therapists will be trained by PI in a 60 minute group session, to be able lead individual or group sessions.

Participants in the A group will receive exercise materials and handouts, a TENS unit and other resources for the individualized intervention plan. A Transcutaneous Electrical Nerve Stimulation (TENS) unit is a device that is included to help with pain control because pain often limits activity performance for cancer patients. It is not used to collect additional data but for pain control, to improve activity performance only for participants who report pain as a barrier in everyday tasks. All participants who receive the device will receive individualized education on how to use the device (during individual sessions). No information will be shared with the device manufacturer. Participants will be allowed to keep the devices to continue using it for pain control after the study. An example of an DFA-approved TENS unit is the TENS 7000 (www.tens7000.com).

ActiveHeal EST (Engage-Sustain-Triumph) group sessions will utilize a developmental group intervention model. Such intervention models allow the group to increasingly take charge of group activities and processes, with more structure and support at the beginning but members gradually take over leadership and group management roles, ideally running the group and meeting shared goals without a therapist by the end of the process . This model is selected because it has potential to enable members to develop relationships and build capacities that allow them to support one another after the intervention period. The model is also selected to allow participants to draw from benefits of group interventions, including installation of hope, universality, imparting of knowledge, altruism, corrective family re-enactment, development of socialization skills, imitative behavior, interpersonal learning, group cohesiveness, catharsis, and finding meaning.

Because these models are known to be optimal with 5-10 participants, Group A participants will be divided into two groups, but the same session plan will be used on the day of the meetings. That is, there will be two similar sessions per day of meeting, and participants will attend one session, with the same group each time. Group members will vote for their preferred activities for the upcoming meeting and the activities that are favored by the majority will be selected if consistent with group goals. These activities may include group physical exercise, healthy meal preparation activity, meditation, yoga, guided imagery, music experience (listening and/or performance) and dance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Occupational Resilience Measure (ORM 1.0)

时间窗: Week 7-8; Week 22-23

The ability to persist in selected daily activity despite challenges

次要结局

  • World Health Organization Quality of Life Scale (WHOQOL-BREF)(Week 7-8; Week 22-23)
  • Psychological Wellbeing Scale(Week 7-8; Week 22-23)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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