Comfort Talk (CT) During Outpatient Chemotherapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chemotherapy Effect
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This pilot trials will be conducted simultaneously in two outpatient oncology clinics located in the Montreal area: 1) Hôpital du Sacré-Coeur de Montréal, and 2) Hôpital de Saint-Eustache. These sites have been selected has they share the same hemato-oncologists, ensuring some consistency in treatment protocols. Site 1 will serve as the experimental site (combining CT with current care) and site 2 will serve as the control site (current care only).Masking: Double (Participant, Outcomes Assessor)Masking Description: 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.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 cance...
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.
Tracking Information
- NCT #
- NCT04173195
- Collaborators
- Not Provided
- Investigators
- Not Provided
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