Gynecologic CancerNCT04852471
Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging
A study testing Standard Post-Operative Counseling + FACT-G and PROM symptom tracker in people with Gynecologic Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This study is investigating a new way to monitor patients who are recovering at home after surgery. This study uses text messages to ask patients to review their own symptoms and then reply with the level of severity of specific symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Standard Post-Operative Counseling + FACT-G and PROM symptom tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2022to 2 May 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years of age or greater.
- Planning to undergo a surgical procedure via a laparotomy incision for a suspected or known gynecologic malignancy. There is no restriction on the spectrum of pathology or disease.
- The ability and willingness to send and receive short messaging service (SMS) text messages.
- Able to read and understand English.
- Willing and able to provide informed consent
Who cannot join
- Persons who are planning to undergo a minimally invasive procedure without laparotomy.
- Persons unable to be contacted by SMS text message or choose to opt-out of the study.
- Patients who do not have access to the internet via a home computer or a smart phone.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging: a Randomized Control Trial (PROMPT Study)
This study is investigating a new way to monitor patients who are recovering at home after surgery. This study uses text messages to ask patients to review their own symptoms and then reply with the level of severity of specific symptoms. Based on each patient's specific response to the text message survey, a pre-programmed, automated response will be sent from the study prompting the patient to take specific actions (or no action if no symptoms). Investigators will assess whether this method improves patients' well-being as compared to the current standard of care for patients. Currently, after surgery, patients are provided counseling and written instructions when they leave the hospital on how to care for themselves at home. If the patient has questions or concerns, they contact their care team. The optimal way to help patients assess their own symptoms at home remains unknown. Investigators are also assessing if using the symptom survey reduces readmissions to the hospital.
- Conditions
- Gynecologic Cancer
- Being tested
- Standard Post-Operative Counseling + FACT-G, PROM symptom tracker
- Keywords
- laparotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Post-Operative Counseling + FACT-GBehavioural
Counseling at discharge + FACT-G at enrollment, at 15-18 and at 30-32 days post-operative.
PROM symptom trackerBehavioural
A 12-item symptom tracker adopted from the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE), delivered via text, on days 4, 6, 8, 12, 18, 24, and 30 post surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standard Post-Operative Counseling + FACT-G (Control Arm) | Active comparator | Patients will receive the standard postoperative counseling at discharge, discharge instructions, and the link to website with postoperative instructions. Patients will complete the Functional Assessment of Cancer Therapy - General (FACT-G). Receives: Behavioral: Standard Post-Operative Counseling + FACT-G |
| Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm) | Experimental | Patients will receive the standard postoperative counseling at discharge, discharge instructions, and the link to website with postoperative instructions. The intervention arm will receive and complete the Patient-Reported Outcome Measure (PROM) survey via the SMS text messaging service on a set schedule. Patients will complete the FACT-G. Receives: Behavioral: Standard Post-Operative Counseling + FACT-G; Behavioral: PROM symptom tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean total score on FACT-G
The mean total score on the FACT-G will be compared between the two arms. The FACT-G is a 27-item questionnaire that covers four HR-QOL sub-domains: physical, social, emotional, and functional well-being. Each of the questions will be scored on a scale from 0 (Not at all) to 4 (Very much) using a manual scoring template in which some items are reverse scored. The minimally important difference (MID) is 5 points for the FACT-G questionnaire. In other words, five points is the most minimal difference between the control group and treatment group scores that would indicate a clinically meaningful change. A positive change in points indicates better QOL.
Measured: 30-32 days post-operative
Secondary outcomes (5)
Proportion of patients who had non-standard clinic visits
The proportion of patients who are seen in the clinic for visits other than a scheduled post-operative visit. Data collected by chart review.
Measured: 30 days post-operative
Proportion of patients who called the care team
Data collected by chart review.
Measured: 30 days post-operative
Proportion of patients seen in urgent care clinics
Data collected by chart review.
Measured: 30 days post-operative
Proportion of patients seen in emergency room
Data collected by chart review.
Measured: 30 days post-operative
Proportion of patients readmitted to hospital
Data collected by chart review.
Measured: 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start5 Jan 2022
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shitanshu Uppal, MBBS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852471
- Sponsor's protocol ID
- UMCC 2020.173
- Other IDs
- HUM00190175
- Status last verified
- Oct 2023
- First submitted
- 16 Apr 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging: a Randomized Control Trial (PROMPT Study)
- ClinicalTrials.gov ID
- NCT04852471
- Acronym / sponsor ID
- UMCC 2020.173
- Conditions
- Gynecologic Cancer
- Keywords
- laparotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 21 Apr 2021 (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.
This study is investigating a new way to monitor patients who are recovering at home after surgery. This study uses text messages to ask patients to review their own symptoms and then reply with the level of severity of specific symptoms. Based on each patient's specific response to the text message survey, a pre-programmed, automated response will be sent from the study prompting the patient to take specific actions (or no action if no symptoms). Investigators will assess whether this method improves patients' well-being as compared to the current standard of care for patients. Currently, after surgery, patients are provided counseling and written instructions when they leave the hospital on how to care for themselves at home. If the patient has questions or concerns, they contact their care team. The optimal way to help patients assess their own symptoms at home remains unknown. Investigators are also assessing if using the symptom survey reduces readmissions to the hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Post-Operative Counseling + FACT-G (Control Arm) | Active comparator | Behavioral: Standard Post-Operative Counseling + FACT-GPatients will receive the standard postoperative counseling at discharge, discharge instructions, and the link to website with postoperative instructions. Patients will complete the Functional Assessment of Cancer Therapy - General (FACT-G). |
| Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm) | Experimental | Behavioral: Standard Post-Operative Counseling + FACT-G, Behavioral: PROM symptom trackerPatients will receive the standard postoperative counseling at discharge, discharge instructions, and the link to website with postoperative instructions. The intervention arm will receive and complete the Patient-Reported Outcome Measure (PROM) survey via the SMS text messaging service on a set schedule. Patients will complete the FACT-G. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years of age or greater.
- Planning to undergo a surgical procedure via a laparotomy incision for a suspected or known gynecologic malignancy. There is no restriction on the spectrum of pathology or disease.
- The ability and willingness to send and receive short messaging service (SMS) text messages.
- Able to read and understand English.
- Willing and able to provide informed consent
Key exclusion criteria (3 listed)
- Persons who are planning to undergo a minimally invasive procedure without laparotomy.
- Persons unable to be contacted by SMS text message or choose to opt-out of the study.
- Patients who do not have access to the internet via a home computer or a smart phone.
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 |
|---|---|---|
| Standard Post-Operative Counseling + FACT-GCounseling at discharge + FACT-G at enrollment, at 15-18 and at 30-32 days post-operative. | Behavioural | Standard Post-Operative Counseling + FACT-G (Control Arm), Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm) |
| PROM symptom trackerA 12-item symptom tracker adopted from the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE), delivered via text, on days 4, 6, 8, 12, 18, 24, and 30 post surgery. | Behavioural | Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm) |
Primary outcome
Mean total score on FACT-G
Time frame: 30-32 days post-operative
The mean total score on the FACT-G will be compared between the two arms. The FACT-G is a 27-item questionnaire that covers four HR-QOL sub-domains: physical, social, emotional, and functional well-being. Each of the questions will be scored on a scale from 0 (Not at all) to 4 (Very much) using a manual scoring template in which some items are reverse scored. The minimally important difference (MID) is 5 points for the FACT-G questionnaire. In other words, five points is the most minimal difference between the control group and treatment group scores that would indicate a clinically meaningful change. A positive change in points indicates better QOL.
5 secondary outcomes
Proportion of patients who had non-standard clinic visits
Time frame: 30 days post-operative
Proportion of patients who called the care team
Time frame: 30 days post-operative
Proportion of patients seen in urgent care clinics
Time frame: 30 days post-operative
Proportion of patients seen in emergency room
Time frame: 30 days post-operative
Proportion of patients readmitted to hospital
Time frame: 30 days post-operative
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 11 Oct 2023.
- 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.
Shitanshu Uppal, MBBS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Post-Operative Counseling + FACT-G and PROM symptom tracker in people with Gynecologic Cancer, run by University of Michigan Rogel 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 5 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: finished, as of the sponsor's last update on 11 Oct 2023. 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?
Mean total score on FACT-G (time frame: 30-32 days post-operative). 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 11 Oct 2023.