Lung Cancer, Anxiety Post SBRTNCT01993901
The Influence of CSRT-led Telephone Follow-up on ESAS Scores in Patients Who Have Been Treated With Lung SBRT
A study testing CSRT led telephone follow up in people with Lung Cancer, Anxiety Post SBRT, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Anxiety Post SBRT
- What is being tested?
- CSRT led telephone follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to 1 Apr 2018
- 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
- Any patient treated with lung SBRT over a specified one year time frame
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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:
- 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.
- Conditions
- Lung Cancer, Anxiety Post SBRT
- Being tested
- CSRT led telephone follow up
- Keywords
- lung SBRT, ESAS, anxiety
- Medical subject headings
- Lung Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSRT led telephone follow upOther
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
| Study group | Role | What they receive |
|---|---|---|
| CSRT led telephone follow up | Experimental | Patients in the experimental arm will be telephoned by the CSRT 4-6 weeks after completion of their treatment to assess any symptoms. Receives: Other: CSRT led telephone follow up |
| Standard Follow up | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in ESAS scores
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
Measured: 4 months after completion of SBRT
Secondary outcomes (1)
Efficacy of CSRT led follow up
Determine if CSRT-led telephone led follow-up has an impact on the ESAS scores of patients treated with lung SBRT
Measured: 4 months after completion of SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start1 Apr 2018
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Why it stopped: Study never officially opened
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Anxiety Post SBRTStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darby Erler, Sunnybrook Health Sciences Centre
- Investigators
- Lisa DiProspero, BSc, MSc, Study director, Toronto Sunnybrook Regional Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993901
- Sponsor's protocol ID
- PBR041575
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2013
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01993901
- Acronym / sponsor ID
- PBR041575
- Conditions
- Lung Cancer, Anxiety Post SBRT
- Keywords
- lung SBRT, ESAS, anxiety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never officially opened
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 25 Nov 2013 (estimated)
- 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.
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.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSRT led telephone follow up | Experimental | Other: CSRT led telephone follow upPatients in the experimental arm will be telephoned by the CSRT 4-6 weeks after completion of their treatment to assess any symptoms. |
| Standard Follow up | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient treated with lung SBRT over a specified one year time frame
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| CSRT led telephone follow upPatients 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 | Other | CSRT led telephone follow up |
Primary outcome
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
1 secondary outcome
Efficacy of CSRT led follow up
Time frame: 4 months after completion of SBRT
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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.
Lisa DiProspero, BSc, MSc study director
Toronto Sunnybrook Regional Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSRT led telephone follow up in people with Lung Cancer, Anxiety Post SBRT, run by Sunnybrook Health Sciences Centre 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 3 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: withdrawn, as of the sponsor's last update on 19 Nov 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in ESAS scores (time frame: 4 months after completion of SBRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2019.