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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993901
Recruitment Status : Withdrawn (Study never officially opened)
First Posted : November 25, 2013
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Darby Erler, Sunnybrook Health Sciences Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer, Anxiety Post SBRT Other: CSRT led telephone follow up Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: 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)
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.
Other: CSRT led telephone follow up
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Patient opinions regarding follow up care [ Time Frame: 4 months after SBRT ]
    Evaluate patients opinions regarding their follow up care



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993901


Locations
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Canada, Ontario
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Study Director: Lisa DiProspero, BSc, MSc Toronto Sunnybrook Regional Cancer Centre
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Responsible Party: Darby Erler, Clinical Specialist Radiation Therapist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01993901    
Other Study ID Numbers: PBR041575
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Darby Erler, Sunnybrook Health Sciences Centre:
lung SBRT, ESAS, anxiety