Telemedicine Counseling for Endometrial Cancer

Overseen By Caroline Kim

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding telemedicine (healthcare services provided via video or phone) to pre-operative counseling benefits patients with endometrial cancer. It specifically compares traditional face-to-face counseling with a combination of face-to-face counseling and a short video review. The goal is to determine if this additional step helps patients feel more informed and prepared for surgery. Eligible participants have early-stage endometrial cancer, are scheduled for minimally invasive surgery, and have internet access at home to view the video. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that telemedicine counseling is safe for endometrial cancer patients?

Research has shown that telemedicine, including video counseling, is generally safe for patients. One study with 259 endometrial cancer patients found satisfaction with telemedicine comparable to traditional counseling, indicating comfort and safety. A review also found asynchronous telemedicine (where patient and provider do not communicate simultaneously) effective for diagnosis and care without increasing risk. Patients can watch videos repeatedly, potentially reducing anxiety. Overall, studies indicate telemedicine is a well-tolerated option for pre-operative counseling, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of integrating telemedicine into preoperative counseling for endometrial cancer patients. Unlike the typical in-person counseling session, this approach adds a 5-minute video that patients can watch at their convenience, reinforcing the information given during their office visit. This method could help improve patient understanding and recall of important information, potentially leading to better preparation and reduced anxiety before surgery. Plus, it offers the flexibility and accessibility of telemedicine, which can be especially beneficial for those with limited access to healthcare facilities.

What evidence suggests that telemedicine counseling is effective for endometrial cancer?

This trial will compare standard pre-operative counseling with an approach that includes both standard counseling and asynchronous telemedicine. Research has shown that telemedicine for pre-surgery counseling in endometrial cancer patients can be as satisfying as in-person meetings. One study found that 78% of patients were satisfied with telemedicine, similar to the 79% satisfaction rate for face-to-face counseling. Telemedicine also reduces anxiety by allowing patients to watch the counseling video at their convenience. Studies have found no difference in health outcomes, such as complications or death rates, between telemedicine and in-person visits. Overall, telemedicine can make healthcare more accessible and convenient without losing effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Shannon D Armbruster, MD, MPH

Principal Investigator

Carilion Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with stage I endometrial cancer, who are scheduled for minimally invasive surgery at Carilion Clinic in Roanoke, VA. Participants must be able to read and understand questionnaires and have internet or cellular access at home.

Inclusion Criteria

Internet/cellular access at home

Ability to read and comprehend materials on questionnaires

My cancer is early-stage endometrial carcinoma, confined to the uterus.

Exclusion Criteria

Patients that do not meet the inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Counseling

Participants receive standard counseling or standard counseling plus asynchronous telemedicine video

1 week

1 visit (in-person or virtual)

Surgery and Immediate Postoperative Period

Participants undergo minimally invasive surgery and complete questionnaires on anxiety and satisfaction

1 week

Follow-up

Participants are monitored for anxiety and satisfaction at the postoperative exam

2-4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Asynchronous telemedicine
• Preoperative counseling

Trial Overview

The study is testing if using telemedicine (remote healthcare services) for preoperative counseling is as good as face-to-face meetings for patients preparing for endometrial cancer surgery.

How Is the Trial Designed?

Group I: Standard Pre-operative Counseling plus Asynchronous Telemedicine Experimental Treatment 2 Interventions

Participants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling.

Group II: Standard Pre-operative Counseling Active Control 1 Intervention

Participants will receive standard counseling.

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Published Research Related to This Trial

In a study of 66 patients with intermediate risk endometrial cancer, treatment involving full lymphadenectomy and postoperative brachytherapy (without teletherapy) resulted in an impressive 97% progression-free survival rate over a mean follow-up of 4.4 years.

The approach was associated with minimal major complications, occurring in only 6% of patients, indicating a favorable safety profile for this treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival of intermediate risk endometrial cancer (stage IG3, IC, II) treated with full lymphadenectomy and brachytherapy without teletherapy. Fanning, J.[2022]

Patients receiving written preoperative information reported higher satisfaction levels compared to those who received verbal information, indicating that written materials may enhance understanding and preparedness for surgery.

The study found that patients who received written information experienced less postoperative pain, shorter hospital stays, and required fewer pain medications, suggesting that written preoperative information can lead to better recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of giving patients verbal or written pre-operative information in gynecologic oncology surgery: a randomized study and the medical-legal point of view. Angioli, R., Plotti, F., Capriglione, S., et al.[2014]

A study involving 271 patients scheduled for elective surgery compared anxiety levels between those receiving preanaesthesia consultations face-to-face and via telephone, but found no significant differences in anxiety levels before and after the consultations.

Despite the lack of difference in anxiety reduction, patients expressed positive feedback about the telemedical consultation, suggesting it may enhance patient satisfaction and warrant further investigation into its impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative anxiety after face-to-face patient assessment versus preanaesthesia telemedicine (PANTEM) in adults: a randomised clinical trial. Gibas, G., Liebisch, M., Eichenberg, C., et al.[2022]

A multicenter clinical trial is evaluating the effectiveness of the Listeo+ mHealth app in improving patient compliance with preoperative recommendations for major ambulatory surgery, involving 790 patients across four hospitals in Spain.

The study aims to reduce the 25% rate of surgical cancellations due to poor compliance by allowing real-time monitoring of patient preparation, potentially leading to better surgical outcomes and resource management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Mobile App on Preoperative Patient Preparation for Major Ambulatory Surgery: Protocol for a Randomized Controlled Trial. Herrera-Usagre, M., Santana, V., Burgos-Pol, R., et al.[2020]

Surgical staging is now the standard treatment for women with endometrial cancer, and it has been shown to be safe when performed by specially trained surgeons.

Routine postoperative teletherapy is not cost-effective and does not improve survival rates, highlighting the need for careful preoperative assessment and the availability of advanced surgical options during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endometrial cancer: is surgical staging necessary? Orr, JW., Roland, PY., Leichter, D., et al.[2019]

In a study of 396 patients with endometrial cancer who underwent hysterectomy and lymphadenectomy, the surgical procedure was found to be safe, with low rates of complications such as surgical site infections (3.5%) and blood loss (mean 336 ml).

The 5-year survival rate for patients classified as surgical stage I disease was high at 97%, indicating that extensive surgical staging does not compromise survival, even for those who do not receive additional teletherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stage I corpus cancer: is teletherapy necessary? Orr, JW., Holimon, JL., Orr, PF.[2019]

Type I endometrial cancer, which is more common and often seen in obese postmenopausal women, accounts for about 80% of endometrial cancer cases, while Type II is less common, more aggressive, and affects younger, thinner women.

The standard treatment involves a total hysterectomy with possible lymphadenectomy, but the safety of laparoscopic surgery for this condition has not been confirmed in randomized trials; however, proper surgical staging can help tailor postoperative radiotherapy to reduce recurrence risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endometrial cancer and its management. Pather, S., O'Leary, M., Carter, J.[2016]

In a study of 29 women with clinical stage II endometrial cancer who received preoperative radiotherapy, the three-year overall survival rate was 79%, but 27.6% experienced disease recurrence, primarily outside the radiated area.

The findings suggest that many patients had high-risk factors for recurrence, indicating a need for alternative treatment strategies, as most recurrences occurred at distant sites rather than within the treated area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative radiotherapy for inoperable stage II endometrial cancer: insights into improving treatment and outcomes. Lee, MH., Aquino-Parsons, C., Hoskins, PJ., et al.[2019]

The Surgical Risk Preoperative Assessment System (SURPAS) received positive feedback from both patients and healthcare providers, highlighting its potential to improve risk assessment processes and enhance patient involvement in decision-making.

Participants noted that while SURPAS is beneficial, it should complement clinical judgment rather than replace it, and there are mixed feelings among patients regarding the impact of risk information on their decision to undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of attitudes towards future implementation of the "Surgical Risk Preoperative Assessment System" (SURPAS) tool: a pilot survey among patients, surgeons, and hospital administrators. Lambert-Kerzner, A., Ford, KL., Hammermeister, KE., et al.[2022]

Preoperative counseling using video (VC) for rectal cancer patients significantly reduced the counseling time compared to conventional counseling (CC), with an average of 20 minutes for VC versus 35 minutes for CC, making it a more efficient option for surgeons.

While there were no significant differences in patient comprehension, satisfaction, or anxiety levels between the two methods, the use of video counseling could help alleviate the burden on surgeons while still providing necessary information to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages of preoperative counseling with video for robotic rectal cancer surgery compared with conventional counseling: A randomized controlled trial. Kasai, S., Yamauchi, S., Tazawa, M., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10832391/

Telemedicine and cancer care: barriers and strategies to ...

In a non-inferiority randomized trial of 259 endometrial cancer patients, there was no difference in reported satisfaction at 78% vs 79% with information ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05712668

Telemedicine Use in Preoperative Counseling for ...

The asynchronous video will be available outside of the office and can be viewed multiple times. The primary endpoint is patient anxiety, measured via the State ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38320467/

Variation in telemedicine usage in gynecologic cancer

Results: Of 3950 patients with ovarian cancer, 1119 (28.3%) had at least one telemedicine visit. Of 2510 patients with endometrial cancer, 720 ( ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1002/jso.27844

Use of telehealth to improve healthcare access and ...

Additionally, there were no differences in 30-day, 90-day morbidity, and 90-day mortality between patients seen via telemedicine and those seen ...

5.

bjgpopen.org

bjgpopen.org/content/8/1/bjgpo.2023.0177

Effectiveness and safety of asynchronous telemedicine ...

This review found asynchronous telemedicine can be effective for making diagnoses, prescribing medications, and providing timely care and increased convenience ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11169987/

Effectiveness and safety of asynchronous telemedicine ...

This review found asynchronous telemedicine can be effective for making diagnoses, prescribing medications, and providing timely care and increased convenience ...

7.

researchgate.net

researchgate.net/publication/377662562_Telemedicine_and_Cancer_Care_Barriers_and_Strategies_to_Optimize_Delivery

Telemedicine and Cancer Care: Barriers and Strategies to ...

Telemedicine holds the potential to transform cancer care delivery and optimize value, access, and quality of care.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10739789/

Asynchronous Telemedicine: A Systematic Literature Review

Asynchronous telemedicine (ATM), which describes telemedical interaction between a patient and provider where neither party communicates simultaneously,