Ignite Creation Date:
2025-12-24 @ 1:47 PM
Ignite Modification Date:
2025-12-24 @ 1:47 PM
Study NCT ID:
NCT04173195
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2019-11-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comfort Talk (CT) During Outpatient Chemotherapy
Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Organization:
Study Overview
Official Title:
Comfort Talk (CT) to Improve Emotional Support and Physical Comfort During Outpatient Chemotherapy: a Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed 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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: