跳至主要内容
临床试验/NCT04173195
NCT04173195已完成不适用

Comfort Talk (CT) to Improve Emotional Support and Physical Comfort During Outpatient Chemotherapy: a Pilot Study

Hopital du Sacre-Coeur de Montreal2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2019年9月23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
49
试验地点
2
主要终点
Changes in emotional support

研究概览

简要总结

Emotional support and physical comfort are two important components of the patient experience at the oncology outpatient clinic. However, current practices do not seem optimal for meeting the psychosocial needs expressed by patients during chemotherapy treatments.

Comfort talk (CT) is a simple, inexpensive intervention that could maximize the feeling of safety and comfort during chemotherapy. Identifying interventions that are interdisciplinary and that can enhance the outpatient patient experience will facilitate access to quality oncology care.

详细描述

The number of cancer cases requiring chemotherapy is on the rise in North America. About 84% of chemotherapy treatments are administered by nurses in a outpatient clinic context. Although outpatient oncology care are generally associated with a significant improvement in the quality of life in cancer patients, one-third of patients believe that health professionals (including nurses) are not doing everything in their power to comfort or relieve discomfort during chemotherapy treatments. Among the known elements for enhancing the well-being of oncology outpatients, comfort talk (CT) has been found to be very effective. Indeed, CT is a simple and direct form of conversation that is inspired by the principles of clinical hypnosis. While the soothing mechanisms of CT are poorly understood, involvement of cortical regions involved in the modulation of emotions and pain is suggested in several neuroimaging studies.This pilot trial serves as a proof of concept and aims to explore whether CT can be used by nurses to optimize the perception of emotional support and physical comfort during outpatient chemotherapy treatments. To do this, patients enrolled in a chemotherapy treatment cycle will be recruited during a visit to the oncology outpatient clinic. Half of the patients will be assigned to enhanced routine care with an CT intervention and the other half will receive routine care without CT. If there is an overlap between CT mechanisms and those involved in the endogenous control of emotions and pain, a significant interaction of these elements on the well-being of patients during chemotherapy treatments is expected. The results of this pilot trials will be used to justify and prepare for a larger study to evaluate the effects of CT on cancer symptom management and treatment at the outpatient clinic.

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
Double (Participant, Outcomes Assessor)

盲法说明

Patients and outcome assessors will be blinded to treatment allocation. Complete blinding of care providers will not possible as the nurses in charge of chemotherapy admnistration will also be responsible to provide the CT intervention.

入排标准

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

入选标准

  • Adult patients (18 years of age and older) with cancer (regardless of stage) who have initiated a outpatient chemotherapy treatment cycle for at least 1 week and who are expected to receive at least two additional treatments related to this cycle will be considered for eligibility.

排除标准

  • BMI ≥30 or pregnancy;
  • With a history of pre-existing chronic pain;
  • History of psychosis or serious mental illness;
  • Receiving anti-cancer treatments for more than 2 years;
  • Any other conditions that make the patient's participation potentially detrimental to his well-being as recommended by the attending physician.

结局指标

主要结局

Changes in emotional support

时间窗: Immediately before/after CT

Perceived support scale, 9 items rated on 0-100mm VAS, with 0 meaning that the support is completely absent and 100 that it is at its optimal level.

Changes in physical comfort

时间窗: Immediately before/after CT

Edmonton Symptom Assessment Scale, 9 items rated on 0-100mm VAS, with 0 meaning that the symptom is absent and 100 that it is the worst possible severity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caroline Arbour

Regular researcher

Hopital du Sacre-Coeur de Montreal

研究点 (2)

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