Comfort Talk (CT) During Outpatient Chemotherapy

NCT04173195 | Completed

• 1 other identifier: 2019-1751
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy Effect

Keywords

Comfort talk; Outpatient clinic; Emotional support; Pain; Nursing care

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

No intervention arm

NO INTERVENTION

Patients assigned to this arm will received current care.

Interventions

Comfort Talk OTHER

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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Related Publications (1)

• 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.

  PMID: 34374847 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regular researcher

Model Details: 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).

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 21, 2019
• Study Start: September 23, 2019
• Primary Completion: December 22, 2019
• Study Completion: March 31, 2020
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)