Comfort Talk (CT) During Outpatient Chemotherapy

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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy Effect
• Intervention / Treatment: Other: Comfort Talk

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4J 1C5
      • Hôpital du Sacré-Coeur de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Comfort Talk; A short and brief conversation based on the principles of clinical hypnosis.
NO_INTERVENTION: No intervention arm; Patients assigned to this arm will received current care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in emotional support	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.	Immediately before/after CT
Changes in physical comfort	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.	Immediately before/after CT

Collaborators and Investigators

• Sponsor: Hopital du Sacre-Coeur de Montreal

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 23, 2019
• Primary Completion (ACTUAL): December 22, 2019
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (ACTUAL): November 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Nursing care; Outpatient clinic; Comfort talk; Emotional support
• Other Study ID Numbers: 2019-1751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No