Chemotherapy EffectNCT04173195
Comfort Talk (CT) During Outpatient Chemotherapy
A study testing Comfort Talk in people with Chemotherapy Effect, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Effect
- What is being tested?
- Comfort Talk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 23 Sep 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Comfort Talk
- Keywords
- Comfort talk, Outpatient clinic, Emotional support, Pain, Nursing care
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort TalkOther
A short and brief conversation based on the principles of clinical hypnosis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Comfort Talk |
| No intervention arm | No intervention | Patients assigned to this arm will received current care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately before/after CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start23 Sep 2019
- Primary completion22 Dec 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Arbour, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173195
- Sponsor's protocol ID
- 2019-1751
- Status last verified
- Mar 2022
- First submitted
- 18 Nov 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34374847
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comfort Talk (CT) to Improve Emotional Support and Physical Comfort During Outpatient Chemotherapy: a Pilot Study
- ClinicalTrials.gov ID
- NCT04173195
- Acronym / sponsor ID
- 2019-1751
- Conditions
- Chemotherapy Effect
- Keywords
- Comfort talk, Outpatient clinic, Emotional support, Pain, Nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Comfort TalkThe 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. |
| No intervention arm | No intervention | –Patients assigned to this arm will received current care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comfort TalkA short and brief conversation based on the principles of clinical hypnosis. | Other | Intervention arm |
Primary outcome
Changes in emotional support
Time frame: Immediately before/after CT
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.
Changes in physical comfort
Time frame: Immediately before/after CT
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 34374847Arbour 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.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy Effect
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
Recruiting
Effect of Pecha Kucha-Based Education on Symptom Management and Quality of Life in Patients Receiving Chemotherapy
Cancer, Neoplams
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Not yet recruitingPhase 3
Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia
Chemotherapy Induced Alopecia, Chemotherapy Side Effects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comfort Talk in people with Chemotherapy Effect, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in emotional support (time frame: Immediately before/after CT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04173195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.