e-Health Intervention for Cancer of the Female Reproductive System

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Hospice, Severe depression, Non-English, others

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

Compensation: Varies

Number of Visits: Unknown

23 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well the 'Day by Day' online program helps patients with advanced gynecologic cancer manage their fears about cancer progression. The program includes group sessions, self-study activities, and periodic updates to teach skills for reducing anxiety and worries.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the e-Health Intervention (Day-by-Day) treatment for cancer of the female reproductive system?

Research shows that online interventions can improve health outcomes like quality of life and symptom management for patients with gynecological cancers. Additionally, digital health strategies have been effective in enhancing the quality of life for breast cancer survivors, suggesting potential benefits for similar interventions in other female reproductive cancers. ^{1 2 3 4 5}

Is the e-Health Intervention generally safe for humans?

Research on similar e-Health interventions for cancer patients, such as those for weight loss and self-management, suggests they are generally safe. These studies focused on improving quality of life and managing symptoms without reporting significant safety concerns. ^{6 7 8 9 10}

How is the e-Health Intervention (Day-by-Day) treatment different from other treatments for cancer of the female reproductive system?

The e-Health Intervention (Day-by-Day) is unique because it leverages digital technology to provide accessible, tailored support and information for women with gynecological cancer, potentially improving their quality of life and addressing psychosocial and physical burdens in a way that traditional treatments may not. ^{2 3 4 11 12}

Research Team

Anne Reb

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for English-speaking women over 18 with stage III or IV gynecologic cancer (ovarian, endometrial, cervical, vulvar/vaginal), at least 3 months post-diagnosis. They must have significant fear of their cancer progressing as measured by a specific questionnaire. Those in hospice care, with severe depression, or unable to follow the study plan are excluded.

Inclusion Criteria

I am 18 years old or older.

My cancer is either improving or getting worse.

I am a woman diagnosed with advanced GYN cancer more than 3 months ago.

Exclusion Criteria

You are currently receiving care in a hospice.

You have been diagnosed with severe depression using the Patient Health Questionnaire (PHQ-9).

Non-English speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development

Patients complete surveys and participate in focus groups to adapt the intervention into a hybrid format

Not specified

DBD Intervention

Patients receive DBD intervention consisting of group and web-based self-study sessions, check-in calls, videos, and handouts

6 weeks

Follow-up

Participants are monitored for fear of progression and secondary outcomes such as distress, anxiety, and depression

6 weeks

Treatment Details

Interventions

• e-Health Intervention (Day-by-Day)

Trial Overview The trial tests an e-health intervention called 'Day-by-Day' designed to manage fears about cancer progression in patients with advanced gynecologic cancers. It's based on the 'Conquer Fear' program and includes discussions, informational media interventions, questionnaires and telephone support to help reduce anxiety.

Participant Groups

Group I: Supportive Care (DBD) Experimental Treatment 5 Interventions

Patients receive DBD intervention consisting of group and web-based self-study sessions and check-in calls on study. Patients also watch videos and receive handouts to reinforce the group sessions.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The pilot study involving 50 breast cancer survivors demonstrated that the e-health platform 'Healthy.me' was generally perceived as a useful resource for tailored health and lifestyle information, particularly in the first month of use.

However, user engagement declined significantly from 76% at one month to 48% at four months, primarily due to time constraints, limited content updates, and technical issues, indicating the need for ongoing improvements to enhance user retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An e-health strategy to facilitate care of breast cancer survivors: A pilot study. Tiong, SS., Koh, ES., Delaney, G., et al.[2022]

This study will compare the effectiveness of a mobile health application combined with face-to-face rehabilitation versus the app alone in improving the Quality of Life for breast cancer survivors, involving women aged 25 to 75 with specific health criteria.

The primary outcome will be assessed after 8 weeks, focusing on Quality of Life, while secondary outcomes will include body composition, functionality, cognitive function, and mental health, highlighting the importance of both technology and professional support in cancer rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial. Lozano-Lozano, M., Martín-Martín, L., Galiano-Castillo, N., et al.[2022]

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]

Online interventions for cancer patients' sexual health have shown significant improvements in sexual function and interest, as well as addressing psychological aspects of sexual problems.

The review of four studies indicates that these interventions effectively combine education, interactive methods, and cognitive behavior therapy to support both cancer survivors and their partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online-based interventions for sexual health among individuals with cancer: a systematic review. Kang, HS., Kim, HK., Park, SM., et al.[2018]

Breast cancer patients often engage in low levels of physical activity during chemotherapy, which can negatively impact their health and recovery.

A Mobile Physical Activity Program was developed to encourage physical activity through a mobile app, offering features like disease tracking and health behavior recording, which could help improve patient engagement and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Physical Activity Intervention for Breast Cancer Patients During Chemotherapy. Geng, Z., Wu, F., Zhang, Y., et al.[2018]

References

1. Australia pubmed.ncbi.nlm.nih.gov

An e-health strategy to facilitate care of breast cancer survivors: A pilot study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial. [2022]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Online-based interventions for sexual health among individuals with cancer: a systematic review. [2018]

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

Effectiveness of Digital Health on the Quality of Life of Long-Term Breast Cancer Survivors: A Systematic Review. [2023]

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

Mobile web-based self-management program for breast cancer patients with chemotherapy-induced amenorrhoea: A quasi-experimental study. [2022]

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

Mobile Physical Activity Intervention for Breast Cancer Patients During Chemotherapy. [2018]

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

Commercially available lifestyle modification program: randomized controlled trial addressing heart and bone health in BRCA1/2+ breast cancer survivors after risk-reducing salpingo-oophorectomy. [2018]

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

A Randomized, Controlled, Multicenter Study of Technology-Based Weight Loss Interventions among Endometrial Cancer Survivors. [2021]

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

The use of novel technology-based weight loss interventions for obese women with endometrial hyperplasia and cancer. [2023]

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

Online interventions for sexual health in cancer. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Digital support for living with and beyond gynaecological cancer. [2021]