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

Trial Summary

What is the purpose of this trial?

To determine whether telemedicine is an acceptable addition to pre-operative counseling, compared to face-to-face communication alone for patients with endometrial cancer.

Will I have to stop taking my current medications?

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

Is telemedicine counseling safe for preoperative preparation?

Telemedicine counseling, including preoperative preparation, is generally considered safe for patients. Studies have shown that using telemedicine for preoperative consultations, such as through phone or video, can effectively prepare patients for surgery without additional safety risks. ^{1 2 3 4 5}

How is telemedicine counseling for endometrial cancer different from other treatments?

Telemedicine counseling for endometrial cancer is unique because it focuses on preoperative education and preparation through remote communication, which can help patients understand their surgery and recovery process better, unlike traditional treatments that primarily involve surgical and radiotherapy interventions. ^{6 7 8 9 10}

Research Team

Shannon D Armbruster, MD, MPH

Principal Investigator

Carilion Clinic

Eligibility Criteria

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

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

I am scheduled for a minimally invasive surgery at Carilion Clinic's Gynecologic Oncology division.

Internet/cellular access at home

Exclusion Criteria

Patients that do not meet the inclusion criteria

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. Ireland 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. [2014]

2. England 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. [2022]

3. Austria pubmed.ncbi.nlm.nih.gov

Preoperative anxiety after face-to-face patient assessment versus preanaesthesia telemedicine (PANTEM) in adults: a randomised clinical trial. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Effect of a Mobile App on Preoperative Patient Preparation for Major Ambulatory Surgery: Protocol for a Randomized Controlled Trial. [2020]

5. Japan pubmed.ncbi.nlm.nih.gov

Advantages of preoperative counseling with video for robotic rectal cancer surgery compared with conventional counseling: A randomized controlled trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Endometrial cancer: is surgical staging necessary? [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Preoperative radiotherapy for inoperable stage II endometrial cancer: insights into improving treatment and outcomes. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Stage I corpus cancer: is teletherapy necessary? [2019]

9. United States 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Endometrial cancer and its management. [2016]