Clinical trial · Interventional
Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic or Breast Cancer
An E-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
This clinical trial tests feasibility, acceptability and how well a virtual mental health intervention, compared to enhanced usual care consisting of an educational intervention, works to address fear of progression for women with high risk or stage III-IV gynecologic or breast cancer. Worrying about cancer coming back or progression is natural for cancer patients. Many cancer patients face stress and uncertainty as they live longer and attend regular check-ups. A supportive program can help to develop skills to feel calmer and more resilient during uncertain times and better manage feelings of fear. The virtual mental health intervention may be a feasible, acceptable and effective may to address fear of progression for women with high risk or stage III-IV gynecologic or breast cancer.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IV Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Endometrioid Adenocarcinoma | Endometrial Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Female Reproductive System Neoplasm | Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stage III Ovarian Cancer AJCC v8 | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Vaginal Cancer AJCC v8 | Malignant Vaginal Neoplasm | CURATED_BROADER |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Intervention | Behavioral | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Internet-Based Intervention | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| Virtual Technology Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (Fear of progression intervention)
- description
- Patients receive access to the Day by Day platform that includes patient partner videos, testimonials, handouts and a community forum. Patients may optionally utilize these resources for 6 weeks. Patients attend online group sessions, over 60 minutes, for every other week for 3 sessions and complete online educational sessions on values clarification, managing worry and unhelpful thoughts, and skills practices to promote healthy coping on alternate weeks for 3 sessions. Patients complete a check in call, for 15-20 minutes, at week 3-4. Patients are asked to practice the skills including attention training, mindfulness, worry postponement, guided imagery and other practices from the intervention for 10-12 minutes, at least 6 days per week for and track their practice on the Day to Day platform for 6 weeks. Patients may be loaned a tablet if needed for 6 weeks.
- interventionNames
- Behavioral: Behavioral Intervention
- Other: Educational Intervention
- Other: Internet-Based Intervention
- Other: Interview
- Other: Survey Administration
- Other: Virtual Technology Intervention
- type
- ACTIVE_COMPARATOR
- label
- Arm II (Educational intervention)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with stage III or IV GYN (ovarian, endometrial, cervical, vulvar/vaginal) or breast cancer who are at least 2 months from initial diagnosis * Women with high-risk disease e.g., carcinosarcoma; ovarian cancer stage II or grade III histology; endometrioid endometrial cancer stage II or III; grade III with LVI or deep invasion; serous, clear cell or undifferentiated histologies; triple negative breast cancer * Score ≥ 34 on the Fear of Progression Short-Form, indicating dysfunctional levels * Age 18 or older; able to read and understand English * Patients in remission or with progressive disease Exclusion Criteria: * Enrolled in hospice * Major depression as assessed by patient health questionnaire (PHQ)-9 * Non-English speaking * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
References
Publications (0)
Data not yet available