Stem Cell Transplantation, HematopoieticNCT02574897
The Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for Chemotherapy
A study testing Electronic symptom survey and Blinded Electronic Symptom Survey in people with Stem Cell Transplantation, Hematopoietic, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this randomized trial will evaluate whether providing clinicians with daily reports from a well-validated, standardized, patient-centered electronic symptom survey tool (PRO-CTCAE) improves symptom burden in patients undergoing high-dose chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stem Cell Transplantation, Hematopoietic
- What is being tested?
- Electronic symptom survey and Blinded Electronic Symptom Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verification of access to a functioning email account
- >= 18 years of age
- <= 75 years of age
- Able to read in English
- Assessed as competent based on discretion of study personnel
- Willing and able to provide signed, informed consent
Who cannot join
- Concurrent participation in LCCC1234
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
About this study
Official title: Evaluating the Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for Intensive Chemotherapy
The purpose of this randomized trial will evaluate whether providing clinicians with daily reports from a well-validated, standardized, patient-centered electronic symptom survey tool (PRO-CTCAE) improves symptom burden in patients undergoing high-dose chemotherapy. Adult inpatients at UNC undergoing high-dose chemotherapy for preparative chemotherapy prior to stem cell infusion. Participants will be randomized into one of two arms: (1) a control arm with standard of care daily clinician interviews or (2) standard of care plus daily electronic symptom surveys, the results of which will be sent to clinicians electronically.
Read the detailed description
The primary objective of the study is to compare peak symptom burden between the two study arms (autologous transplant vs. allogeneic transplant). Peak symptom burden will also be compared between the two study arms within both subgroups of patients (myeloablative vs. reduced intensity conditioning). Secondary outcomes that will also be compared between the two arms include: changes in patient-reported quality of life, time to supportive care treatment changes, length of hospital stay, thirty day readmission rate after discharge, days alive and out of the hospital in the 100 days since admission, and overall survival. Additionally, measures of physical activity will be captured through physiological monitoring in order to explore associations with patient-reported symptom measures. Patient and clinician satisfaction will also be evaluated.
In this study, the investigators will use an electronic survey to assess 16 patient-reported symptoms to calculate a symptom score that may range from 0-61 each day. This symptom score represents the symptom burden for the patient on that particular day. Symptom burden is anticipated to peak between days 7 and 14, so the investigators will define peak symptom burden as the average of the symptom scores on days 7, 10 and 14. In both arms, symptoms will be assessed on these days in order to compare peak burden.
- Conditions
- Stem Cell Transplantation, Hematopoietic
- Being tested
- Electronic symptom survey, Blinded Electronic Symptom Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic symptom surveyOther
Also called Online Daily Symptom Survey
Standard of care plus daily electronic symptom surveys, the results of which are sent to clinicians electronically.
Blinded Electronic Symptom SurveyOther
Standard of care daily clinician interviews with blinded symptom surveys
| Study group | Role | What they receive |
|---|---|---|
| Electronic Symptom Survey | Experimental | Patients randomized to the intervention arm will fill out the daily PRO-CTCAE electronic symptom survey. The intervention consists of sending the results of the surveys in the intervention arm to the clinical care team. The four symptom-specific PROMIS subsets (Anxiety, Depression, Fatigue, and Sleep Disturbance) will be filled out weekly while patients are admitted to the hospital. Patients will again complete the 6 minute walk distance testing, HRQoL surveys, and PASS assessment at the time of discharge. Patients in the intervention arm will complete a satisfaction survey at discharge. HRQoL (by mail) and PASS (by telephone) will be assessed for a third time 30 days after discharge. Receives: Other: Electronic symptom survey |
| Blinded Electronic Symptom Survey | Active comparator | Patients in the control arm will only fill out the symptom survey at the time of admission and days 7, 10, and 14. The results of symptom surveys from the patients in the control arm will not be sent to providers, but will be used for data analysis purposes only. The four symptom-specific PROMIS subsets (Anxiety, Depression, Fatigue, and Sleep Disturbance) will be filled out weekly while patients are admitted to the hospital. Patients will again complete the 6 minute walk distance testing, HRQoL surveys, and PASS assessment at the time of discharge. HRQoL (by mail) and PASS (by telephone) will be assessed for a third time 30 days after discharge. Receives: Other: Blinded Electronic Symptom Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average peak symptom burden in the intervention group versus the control group
Peak symptom burden is defined as the average symptom score on chemotherapy days+7, +10, and +14 (relative to transplant day 0) as measured by the PRO-CTCAE. There are 16 items on the PRO-CTCAE questionnaire. Fifteen items are worth 0-4 points each and one item is worth 0-1 point. This translates to a symptom score range of 0-61 per day, which will be averaged over the three days. The outcome is the comparison of average peak symptom burden scores between the two groups.
Measured: Measured by comparing the average PRO-CTCAE scores from Day+7, Day+10, and Day+14 in the intervention compared to the control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startJul 2014
- Primary completion30 Jun 2017
- Study completionSep 2017
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 Stem Cell Transplantation, HematopoieticStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley L Bryant, PHD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574897
- Sponsor's protocol ID
- LCCC 1404
- Status last verified
- Mar 2018
- First submitted
- 20 Feb 2015
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bryant AL, Coffman E, Phillips B, Tan X, Bullard E, Hirschey R, Bradley J, Bennett AV, Stover AM, Song L, Shea TC, Wood WA. Pilot randomized trial of an electronic symptom monitoring and reporting intervention for hospitalized adults undergoing hematopoietic stem cell transplantation. Support Care Cancer. 2020 Mar;28(3):1223-1231. doi: 10.1007/s00520-019-04932-9. Epub 2019 Jun 20.
PubMed 31222392
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for Intensive Chemotherapy
- ClinicalTrials.gov ID
- NCT02574897
- Acronym / sponsor ID
- LCCC 1404
- Conditions
- Stem Cell Transplantation, Hematopoietic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 14 Oct 2015 (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 purpose of this randomized trial will evaluate whether providing clinicians with daily reports from a well-validated, standardized, patient-centered electronic symptom survey tool (PRO-CTCAE) improves symptom burden in patients undergoing high-dose chemotherapy. Adult inpatients at UNC undergoing high-dose chemotherapy for preparative chemotherapy prior to stem cell infusion. Participants will be randomized into one of two arms: (1) a control arm with standard of care daily clinician interviews or (2) standard of care plus daily electronic symptom surveys, the results of which will be sent to clinicians electronically.
Detailed description
The primary objective of the study is to compare peak symptom burden between the two study arms (autologous transplant vs. allogeneic transplant). Peak symptom burden will also be compared between the two study arms within both subgroups of patients (myeloablative vs. reduced intensity conditioning). Secondary outcomes that will also be compared between the two arms include: changes in patient-reported quality of life, time to supportive care treatment changes, length of hospital stay, thirty day readmission rate after discharge, days alive and out of the hospital in the 100 days since admission, and overall survival. Additionally, measures of physical activity will be captured through physiological monitoring in order to explore associations with patient-reported symptom measures. Patient and clinician satisfaction will also be evaluated.
In this study, the investigators will use an electronic survey to assess 16 patient-reported symptoms to calculate a symptom score that may range from 0-61 each day. This symptom score represents the symptom burden for the patient on that particular day. Symptom burden is anticipated to peak between days 7 and 14, so the investigators will define peak symptom burden as the average of the symptom scores on days 7, 10 and 14. In both arms, symptoms will be assessed on these days in order to compare peak burden.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Symptom Survey | Experimental | Other: Electronic symptom surveyPatients randomized to the intervention arm will fill out the daily PRO-CTCAE electronic symptom survey. The intervention consists of sending the results of the surveys in the intervention arm to the clinical care team. The four symptom-specific PROMIS subsets (Anxiety, Depression, Fatigue, and Sleep Disturbance) will be filled out weekly while patients are admitted to the hospital. Patients will again complete the 6 minute walk distance testing, HRQoL surveys, and PASS assessment at the time of discharge. Patients in the intervention arm will complete a satisfaction survey at discharge. HRQoL (by mail) and PASS (by telephone) will be assessed for a third time 30 days after discharge. |
| Blinded Electronic Symptom Survey | Active comparator | Other: Blinded Electronic Symptom SurveyPatients in the control arm will only fill out the symptom survey at the time of admission and days 7, 10, and 14. The results of symptom surveys from the patients in the control arm will not be sent to providers, but will be used for data analysis purposes only. The four symptom-specific PROMIS subsets (Anxiety, Depression, Fatigue, and Sleep Disturbance) will be filled out weekly while patients are admitted to the hospital. Patients will again complete the 6 minute walk distance testing, HRQoL surveys, and PASS assessment at the time of discharge. HRQoL (by mail) and PASS (by telephone) will be assessed for a third time 30 days after discharge. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Verification of access to a functioning email account
- >= 18 years of age
- <= 75 years of age
- Able to read in English
- Assessed as competent based on discretion of study personnel
Key exclusion criteria (1 listed)
- Concurrent participation in LCCC1234
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 |
|---|---|---|
| Electronic symptom surveyAlso: Online Daily Symptom SurveyStandard of care plus daily electronic symptom surveys, the results of which are sent to clinicians electronically. | Other | Electronic Symptom Survey |
| Blinded Electronic Symptom SurveyStandard of care daily clinician interviews with blinded symptom surveys | Other | Blinded Electronic Symptom Survey |
Primary outcome
Average peak symptom burden in the intervention group versus the control group
Time frame: Measured by comparing the average PRO-CTCAE scores from Day+7, Day+10, and Day+14 in the intervention compared to the control group
Peak symptom burden is defined as the average symptom score on chemotherapy days+7, +10, and +14 (relative to transplant day 0) as measured by the PRO-CTCAE. There are 16 items on the PRO-CTCAE questionnaire. Fifteen items are worth 0-4 points each and one item is worth 0-1 point. This translates to a symptom score range of 0-61 per day, which will be averaged over the three days. The outcome is the comparison of average peak symptom burden scores between the two groups.
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 22 Mar 2018.
- Derived from this study: PubMed 31222392Bryant AL, Coffman E, Phillips B, Tan X, Bullard E, Hirschey R, Bradley J, Bennett AV, Stover AM, Song L, Shea TC, Wood WA. Pilot randomized trial of an electronic symptom monitoring and reporting intervention for hospitalized adults undergoing hematopoietic stem cell transplantation. Support Care Cancer. 2020 Mar;28(3):1223-1231. doi: 10.1007/s00520-019-04932-9. Epub 2019 Jun 20.
- Individual participant dataSharing planned: No
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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.
Ashley L Bryant, PHD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic symptom survey and Blinded Electronic Symptom Survey in people with Stem Cell Transplantation, Hematopoietic, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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 6 inclusion and 1 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 22 Mar 2018. 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 United States. 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?
Average peak symptom burden in the intervention group versus the control group (time frame: Measured by comparing the average PRO-CTCAE scores from Day+7, Day+10, and Day+14 in the intervention compared to the control group). 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 NCT02574897, 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 22 Mar 2018.