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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an electronic health program called Day-by-Day, designed to help women with advanced gynecologic cancers manage fears about disease progression or recurrence. Adapted from a successful early-stage cancer approach, the program includes group sessions, online self-study, and support calls to teach anxiety management skills. Women with stage III or IV ovarian, endometrial, cervical, or vulvar/vaginal cancer who feel very worried about their cancer worsening might be a good fit for this study. As an unphased trial, this study offers participants a unique opportunity to access innovative support strategies tailored to their needs.

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 prior data suggests that this e-health intervention is safe for managing fears in patients with gynecologic cancer?

Research has shown that the "Day-by-Day" e-health program is designed to help cancer patients manage their fears about the illness. This program is based on "Conquer Fear," which has benefited people with early-stage cancer. Although specific data on the safety of "Day-by-Day" for this trial is not available, the program includes group sessions, videos, and handouts. These activities are generally safe because they don't involve medication or physical treatments.

Since the program doesn't use drugs, side effects are usually not a concern. The focus is on teaching skills to cope with anxiety and worries, which is a safe approach. Participants can expect a supportive environment to help manage the emotional challenges related to cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The e-Health Intervention (Day-by-Day) is unique because it combines group and web-based self-study sessions, check-in calls, videos, and handouts to support patients with cancer of the female reproductive system. Unlike traditional treatments such as surgery, chemotherapy, or radiation, which focus on physically targeting the cancer, this intervention emphasizes emotional and psychological support. Researchers are excited about this approach because it aims to enhance patients' quality of life and mental health during treatment, potentially leading to improved overall outcomes. This holistic method offers a fresh perspective by integrating technology and personal support into cancer care.

What evidence suggests that this e-health intervention is effective for managing fears about cancer progression?

Research has shown that online programs can improve the quality of life and body image for patients with gynecologic cancer. Although results on symptom reduction are mixed, these programs can encourage cancer survivors to become more active. In this trial, participants will receive the "Day-by-Day" program, which aims to reduce fears of cancer recurrence by using methods from the successful "Conquer Fear" program. This approach helps patients manage anxiety by teaching them how to shift their thoughts. In summary, online health programs appear promising in supporting the mental well-being of cancer patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Anne Reb

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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

My cancer is either improving or getting worse.

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

Ability to read and understand English

Exclusion Criteria

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

You are currently receiving care in a hospice.

Non-English speaking

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. withpower.com withpower.com/trial/e-health-intervention-for-cancer-of-the-female-reproductive-system-1c862

e-Health Intervention for Cancer of the Female ... This trial studies how well the 'Day by Day' online program helps patients with advanced gynecologic cancer manage their fears about cancer progression.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11565089/

Electronic Health Interventions and Cervical Cancer Screening Cervical Cancer Screening. The cervical cancer screening rate was the primary outcome in 12 out of 14 articles (86%) [26-32,34-38].

3. sciencedirect.com sciencedirect.com/science/article/pii/S0090825820309902

The effectiveness of online interventions for patients with ... Online interventions improved quality of life and body images in patients with gynecological cancer, but there were inconclusive effects on symptom distress, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10837252/

The effectiveness of E-health interventions promoting ... The results showed that E-health interventions improved moderate to vigorous physical activity (MVPA) among cancer survivors (SMD = 0.26, 95% CI ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06619769

eSense-Cancer: Adapting an Online Intervention for ... This research aims to assess how well an adapted online health intervention meets the sexual health needs of gynecologic cancer survivors.

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05786456?keyword=%22Vaginal%20Cancer%22

San Mateo Clinical Trial e-Health Intervention (Day-by- ... To explore the preliminary efficacy of day-by-day (DBD) on reducing FOP (primary outcome) and improving secondary outcomes of distress, anxiety, depression, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12443879/

Systematic nurse-led consultations based on electronic ... This study aimed to investigate the feasibility of nurse-led consultations based on ePRO for women with endometrial or ovarian cancer ...

8. go.drugbank.com go.drugbank.com/conditions/DBCOND0052234

Malignant Female Reproductive System Neoplasm ... e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study, No drug ...

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00309

e-Health Intervention (Day-by-Day) for the Management of ... This clinical trial studies how well an electronic (e)-health intervention (day-by-day) works in managing fears or worries about cancer growing, spreading, ...