Online Health Support for Endometrial Cancer

(RESILIENCE Trial)

Recruiting at 1 trial location

Overseen By Teresita Gormaz, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Corticosteroids, Anti-obesity drugs

Disqualifiers: Recurrent disease, Bariatric surgery, Type 1 diabetes, Current smoker, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

148 Participants Needed

Trial Summary

What is the purpose of this trial?

RESILIENCE is 24-week randomized controlled trial that assesses the efficacy of a digital wellness platform, combined with online support from healthcare professionals, to enhance waist circumference and other vital health outcomes in endometrial cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking insulin, sulfonylureas, GLP-1 agonists, corticosteroids, or anti-obesity drugs, you may not be eligible to participate.

What data supports the effectiveness of the treatment My Viva Plan, Online healthcare professional support, Digital Wellness Platform, Online Healthcare Professional Support, Telehealth Support for endometrial cancer?

Online interventions have been shown to improve health outcomes like quality of life and symptom distress for patients with gynecological cancers, suggesting that similar online support systems could be beneficial for endometrial cancer patients. ^{1 2 3 4 5}

Is the Online Health Support for Endometrial Cancer generally safe for humans?

The research on similar digital health platforms, like the one for hysterectomy recovery, shows that they are generally safe and well-received by users, helping to reduce worry and anxiety during recovery. ^{6 7 8 9 10}

How is the treatment 'My Viva Plan' for endometrial cancer different from other treatments?

My Viva Plan is unique because it offers online health support through a digital wellness platform, providing personalized guidance and support from healthcare professionals, which is not typically available in standard treatments for endometrial cancer. This approach can enhance emotional well-being and symptom management by offering easy access to professional advice and peer support, similar to other successful online support systems used in cancer care. ^{10 11 12 13 14}

Research Team

Carla Prado, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for adults over 18 who've had low-grade, early-stage endometrial cancer and are 1-5 years post-surgery. They should have a BMI between 30 and 45, speak English, but not be pregnant or have metal implants that affect imaging tests. Those with eating disorders, recent weight changes, uncontrolled diabetes or thyroid issues, on certain medications, very active or on strict diets aren't eligible.

Inclusion Criteria

I had early-stage, low-grade endometrial cancer.

Able to speak, read and understand English

I finished my cancer treatment and surgery between 1 month and 5 years ago.

Exclusion Criteria

Type 1 diabetes; uncontrolled thyroid disorder or type 2 diabetes

I am on medication that can change my metabolism or body weight.

Self-report following a structured hypocaloric or a restrictive diet in the past three months, or self-report currently following a vegan diet but for no more than two years

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with a digital wellness platform for 24 weeks, with the first 16 weeks including expert guidance and the following 8 weeks being self-guided.

24 weeks

Regular online interactions and support calls

Follow-up

Participants are monitored for changes in body composition and cardiometabolic health outcomes after the treatment phase.

4 weeks

Treatment Details

Interventions

• My Viva Plan
• Online healthcare professional support

Trial Overview The RESILIENCE trial is testing an online health platform called My Viva Plan along with professional support to see if it helps reduce waist size and improve health in survivors of endometrial cancer over a period of 24 weeks.

Participant Groups

Group I: Intervention group Experimental Treatment 2 Interventions

Participants will receive the intervention for 24 weeks. The first 16 weeks will involve an intensive behavioral program (digital wellness platform plus online healthcare professional support), followed by an 8-week maintenance period (digital wellness platform alone). At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.

Group II: Control group Active Control 1 Intervention

At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

The study evaluated patient-reported outcomes (PROs) in women with endometrial cancer using the Slovenian version of the EORTC QLQ-EN24 questionnaire, highlighting that gastrointestinal symptoms and pain were linked to lower overall PRO scores.

Findings suggest that individualized follow-ups focusing on PROs, particularly addressing sexual health and body image, could enhance long-term outcomes for women post-treatment for endometrial cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Patient-Reported Symptoms and Functioning after Treatment for Endometrial Cancer. Sobočan, M., Gašpar, D., Gjuras, E., et al.[2022]

A multi-centre randomized controlled trial showed that telephone follow-up (TFU) by clinical nurse specialists (CNSs) is positively received by patients with endometrial cancer, offering convenience and personalized care that meets their psychosocial needs.

CNSs also valued TFU for its structured approach, which allowed them to effectively address patients' holistic needs, suggesting that this model of care can enhance self-management and overall well-being for women post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone follow-up after treatment for endometrial cancer: A qualitative study of patients' and clinical nurse specialists' experiences in the ENDCAT trial. Williamson, S., Beaver, K., Gardner, A., et al.[2022]

Implementing enhanced recovery pathways in gynaecological oncology significantly improves postoperative recovery, reduces complications, and lowers healthcare costs, emphasizing the importance of comprehensive peri-operative care.

Incorporating patient-reported outcome data into these pathways allows for better understanding of patient experiences and symptoms, facilitating shared decision-making and ongoing quality improvement in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery pathways and patient-reported outcome measures in gynaecological oncology. Chen, Q., Mariano, ER., Lu, AC.[2021]

Online interventions have been found to significantly improve the quality of life and body image in patients with gynecological cancer, based on a review of 24 studies.

However, the effects of these interventions on symptom distress, social support, psychological distress, and sexual well-being remain inconclusive, indicating a need for further research with more rigorous study designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of online interventions for patients with gynecological cancer: An integrative review. Lin, H., Ye, M., Chan, SW., et al.[2021]

A web-based survivorship care plan application (SCP-A) significantly reduced unmet needs and fear of recurrence in women with breast cancer over a 12-month period, as shown by a study involving 165 participants.

Women using the SCP-A reported improved quality of life compared to those in the control group, indicating that such digital tools can be effective in supporting breast cancer survivors post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of an E-based survivorship care plan for breast cancer survivors: A quasi-experimental study. Fang, SY., Wang, YL., Lu, WH., et al.[2020]

A newly developed website for women recovering from hysterectomy provided tailored, timely information based on their recovery stage, which was well-received by participants.

In a study with 31 women, the website was found to be user-friendly and informative, helping to reduce anxiety and guide recovery decisions, suggesting it could be a cost-effective tool for postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a web site to improve recovery from hysterectomy. Dukeshire, S., Gilmour, D., MacDonald, N., et al.[2022]

The I-Can Manage program was developed through a user-centered co-design process involving 16 cancer patients and 19 clinicians, focusing on self-management of treatment toxicities with evidence-based content and features tailored to patient needs.

Usability testing showed high patient satisfaction with the program, indicated by a mean score of 3.75 on the Post-Study System Usability Questionnaire, suggesting it effectively supports patients in managing their cancer treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. Howell, D., Bryant Lukosius, D., Avery, J., et al.[2023]

The EngagedMD multimedia platform significantly enhances patient understanding and satisfaction regarding IVF and OI-IUI treatments, with 88% of patients feeling better prepared to consent and 83% reporting increased satisfaction with their care.

Providers also recognized the platform's benefits, with 63% agreeing it improved patient learning and standardized information dissemination, indicating its effectiveness in the informed consent process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the EngagedMD multimedia platform to improve informed consent for ovulation induction, intrauterine insemination, and in vitro fertilization. Madeira, JL., Rehbein, J., Christianson, MS., et al.[2019]

This pilot study aims to evaluate the effectiveness of using the 'My HealtheVet' patient portal to enhance knowledge and shared decision-making (SDM) about menopause among women veterans, with a focus on those receiving educational interventions through secure messaging.

If successful, the program could significantly improve patient-provider communication regarding menopause management, potentially serving as a scalable model for other healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Patient Portal Intervention for Menopause Knowledge and Shared Decision-Making. Dang, S., Thavalathil, B., Ruiz, D., et al.[2020]

The implementation of a low-cost virtual interaction system (VIS) in Zambia's gynecologic oncology tumor board was found to be feasible and acceptable, enhancing patient navigation and management despite challenges in a low-resource environment.

During the 12-week study, 197 patients were registered, with 130 entered into the VIS; however, less than half had management decisions recorded, highlighting the need for consistent data management to improve patient care and reduce delays in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use a virtual interactive system to enhance gynecologic oncology multi-disciplinary care in Zambia. Pattee, K., Msadabwe, S., Pfaendler, K., et al.[2022]

The Breast Cancer e-Support mobile app is designed to improve self-efficacy, social support, and symptom management for women undergoing chemotherapy, with a study involving 108 participants to assess its effectiveness over 6 months.

This study is the first in China to rigorously evaluate a mobile app intervention for breast cancer patients, aiming to enhance their quality of life and psychological well-being through tailored support and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: study protocol for a randomized controlled trial. Zhu, J., Ebert, L., Liu, X., et al.[2022]

A pilot study involving 27 gynecologic cancer patients showed that a 12-week web-based support group focusing on sexuality-related topics was both feasible and well-accepted, providing significant emotional support and improved body image.

Participants reported benefits such as increased emotional well-being and comfort in discussing sensitive topics, highlighting the effectiveness of online support groups in addressing psychosexual distress among gynecologic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study of an internet-based support group for women with sexual distress due to gynecologic cancer. Wiljer, D., Urowitz, S., Barbera, L., et al.[2022]

In a 1-year study involving 325 breast and prostate cancer patients, the WebChoice application significantly reduced overall symptom distress compared to a control group, indicating its potential effectiveness in managing cancer-related symptoms.

While the primary outcome showed positive results, secondary outcomes like depression improved only in the WebChoice group, while the control group experienced declines in self-efficacy and health-related quality of life, suggesting that WebChoice may enhance patient support and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an internet support system to assist cancer patients in reducing symptom distress: a randomized controlled trial. Ruland, CM., Andersen, T., Jeneson, A., et al.[2022]

The eHealth system CHESS was effectively utilized by low-income women with breast cancer, with participants logging on and spending more time using the system compared to more affluent users in previous studies.

Women using CHESS showed significant improvements in social support, negative emotions, participation in healthcare, and information competence compared to a control group, indicating that eHealth interventions can positively impact the quality of life for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and Impact of eHealth System by Low-income Women With Breast Cancer. Gustafson, DH., McTavish, FM., Stengle, W., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Patient-Reported Symptoms and Functioning after Treatment for Endometrial Cancer. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

Telephone follow-up after treatment for endometrial cancer: A qualitative study of patients' and clinical nurse specialists' experiences in the ENDCAT trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Enhanced recovery pathways and patient-reported outcome measures in gynaecological oncology. [2021]

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

The effectiveness of online interventions for patients with gynecological cancer: An integrative review. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of an E-based survivorship care plan for breast cancer survivors: A quasi-experimental study. [2020]

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

Development and evaluation of a web site to improve recovery from hysterectomy. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. [2023]

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

Using the EngagedMD multimedia platform to improve informed consent for ovulation induction, intrauterine insemination, and in vitro fertilization. [2019]

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

A Patient Portal Intervention for Menopause Knowledge and Shared Decision-Making. [2020]

10. England pubmed.ncbi.nlm.nih.gov

The use a virtual interactive system to enhance gynecologic oncology multi-disciplinary care in Zambia. [2022]

11. England pubmed.ncbi.nlm.nih.gov

A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: study protocol for a randomized controlled trial. [2022]

12. England pubmed.ncbi.nlm.nih.gov

A qualitative study of an internet-based support group for women with sexual distress due to gynecologic cancer. [2022]

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

Effects of an internet support system to assist cancer patients in reducing symptom distress: a randomized controlled trial. [2022]

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

Use and Impact of eHealth System by Low-income Women With Breast Cancer. [2018]