The Influence of CSRT-led Telephone Follow-up on ESAS Scores in Patients Who Have Been Treated With Lung SBRT

November 15, 2019 updated by: Darby Erler, Sunnybrook Health Sciences Centre

The Influence of Clinical Specialist Radiation Therapist (CSRT)-Led Telephone Follow-up on Edmonton Symptom Assessment Scale (ESAS) Scores in Patients Who Have Been Treated With Lung Stereotactic Body Radiation Therapy (SBRT)

The principal aim of this study is to prospectively assess if Clinical Specialist Radiation Therapist (CSRT) led telephone follow up after treatment with lung Stereotactic Body Radiation Therapy (SBRT) has an impact on patient symptom burden as assessed by Edmonton Symptom Assessment Scale (ESAS) scores.

Study Overview

Status

Withdrawn

Intervention / Treatment

Detailed Description

Design:

The design of this study is a randomized control trial. The study population will include patients treated with lung SBRT at Sunnybrook Odette Cancer Centre (OCC) over a specified 1 year time period who have consented to participating in the study.

Methods:

Patients who consent to the study will be randomized into either the control group or intervention group. Simple randomization will be completed using a computer-generated random number table. Baseline ESAS scores will be collected on the last day of radiation treatment for both groups. Patients in the intervention group will be telephoned by the CSRT 4-6 weeks after completion of their treatment to assess any symptoms. The CSRT will advise the patient on how to manage their side effects and address any anxieties the patient may feel based on published response care paths such as Cancer Care Ontario's Symptom Management Guide. Referrals to the attending radiation oncologist will be made if the patients response in the physical items of ESAS such as pain, nausea and shortness of breath increases to above 2 from their baseline or if they require medical management for a side effect such as esophagitis. If there is an increase in the emotional symptom scores to greater than 2, the CSRT will discuss supportive options and facilitate a referral to social work with the patients' permission. Each telephone call will be logged on a standard template. A second follow up telephone call will be made at 12 weeks post treatment if required in order to address treatment related side effects that were identified during the first call and any interventions that were recommended. When the patient returns to clinic for their first regularly scheduled follow-up appointment, ESAS will be completed as well as a questionnaire to assess their opinions regarding their follow up.

Patients in the control group will have the standard follow up plan as outlined earlier (CT of the chest, abdomen and pelvis prior to follow-up with the radiation oncologist 4 months after the completion of their treatment) and will be asked to complete a questionnaire to assess their opinions regarding follow up during their clinic appointment. In order to control for an "attention effect" that may be seen in the intervention group, patients in the control group will get a placebo or sham telephone call initiated by a research assistant 4-6 weeks after completion of their treatment. This telephone call will simply confirm their follow up appointment and should the patient bring up any issues, they will be referred to the appropriate nursing telephone line.

Inclusion criteria:

• Any patient treated with lung SBRT over a specified one year time frame.

Exclusion criteria:

  1. Patients who are not 18 years of age or greater
  2. Patients whose first language is not English and require translation.
  3. Patients who have poor hearing and find it difficult to carry on a telephone conversation.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Any patient treated with lung SBRT over a specified one year time frame

Exclusion Criteria:

  • Patients who are not 18 years of age or greater
  • Patients whose first language is not English and require translation.
  • Patients who have poor hearing and find it difficult to carry on a telephone conversation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CSRT led telephone follow up
Patients in the experimental arm will be telephoned by the CSRT 4-6 weeks after completion of their treatment to assess any symptoms.
Patients in the intervention group will be telephoned by the CSRT 4-6 weeks after completion of their treatment to assess any symptoms. A second follow up telephone call will be made at 12 weeks post treatment if required in order to address treatment related side effects that were identified during the first call and any interventions that were recommended
No Intervention: Standard Follow up
Patients in the control group will have the standard follow up (CT of the chest, abdomen and pelvis prior to follow-up with the radiation oncologist 4 months after the completion of their treatment). In order to control for an "attention effect" that may be seen in the intervention group, patients in the control group will get a placebo or sham telephone call initiated by a research assistant 4-6 weeks after completion of their treatment. This telephone call will simply confirm their follow up appointment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ESAS scores
Time Frame: 4 months after completion of SBRT
Measure changes in ESAS scores in patients who have been treated with lung SBRT from the last day of treatment to the first follow up appointment
4 months after completion of SBRT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of CSRT led follow up
Time Frame: 4 months after completion of SBRT
Determine if CSRT-led telephone led follow-up has an impact on the ESAS scores of patients treated with lung SBRT
4 months after completion of SBRT

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient opinions regarding follow up care
Time Frame: 4 months after SBRT
Evaluate patients opinions regarding their follow up care
4 months after SBRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Lisa DiProspero, BSc, MSc, Toronto Sunnybrook Regional Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • PBR041575

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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