Comfort Talk (CT) During Outpatient Chemotherapy

NCT ID: NCT04173195

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2020-03-31

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.

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.

Conditions

Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention arm

The CT intervention will be administered by the nurse in charge of the chemotherapy 5 min after the initiation. the CT content will be partially script.

Group Type: EXPERIMENTAL

Comfort Talk

Intervention Type: OTHER

A short and brief conversation based on the principles of clinical hypnosis.

No intervention arm

Patients assigned to this arm will received current care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Comfort Talk

A short and brief conversation based on the principles of clinical hypnosis.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Caroline Arbour

Regular researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Countries

Canada

References

Arbour C, Tremblay M, Ogez D, Martineau-Lessard C, Lavigne G, Rainville P. Feasibility and acceptability of hypnosis-derived communication administered by trained nurses to improve patient well-being during outpatient chemotherapy: a pilot-controlled trial. Support Care Cancer. 2022 Jan;30(1):765-773. doi: 10.1007/s00520-021-06481-6. Epub 2021 Aug 10.

Reference Type: BACKGROUND

PMID: 34374847 (View on PubMed)

Other Identifiers

2019-1751

Identifier Type: -

Identifier Source: org_study_id