Stress management for breast and gynecologic cancer patients in Vietnam
A Pilot Randomized Controlled Trial of Self-Help Plus Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
This study tests a new stress management program for breast and gynecologic cancer patients in Vietnam to see if it can help them feel better emotionally compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 285 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Boston University Academic / other |
| Locations | 6 sites (Can Tho and 5 other locations) |
| Trial ID | NCT06398067 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the Vietnamese Self Help Plus (vSH+) stress management intervention among breast and gynecologic cancer patients in Vietnam. It is a randomized controlled trial where participants are assigned to either the vSH+ intervention or enhanced usual care. The study aims to address the psychological distress often experienced by cancer patients, which is frequently overlooked in clinical settings. Participants will receive an in-person informational session tailored to their assigned study arm, where informed consent will be obtained.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a recent diagnosis of breast or gynecologic cancer who are currently receiving treatment with curative intent.
Not a fit: Patients with severe chronic diseases or those at imminent risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and well-being of cancer patients in Vietnam.
How similar studies have performed: Other studies have shown success with similar stress management interventions, indicating potential for positive outcomes in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or older * Have a clinician-confirmed diagnosis within the past 12 months of first-time breast and/or gynecologic cancer (e.g., cervical, ovarian, uterine, vaginal, vulvar) in stages I-III * Currently or will receive treatment with curative intent * Score less than 8 on the National Comprehensive Cancer Network (NCCN) Distress Thermometer, indicating low to moderate levels of distress * Score less than 15 on the Patient Health Questionnaire-9 items (PHQ-9, indicating low to moderate levels of depression Exclusion Criteria: * Selected '2 Several days' or '3 Almost everyday' on PHQ9 item #9, indicating indicating imminent risk of suicide * Have severe chronic diseases (e.g., coronary heart disease, chronic obstructive pulmonary disease (COPD), chronic renal failure), at the discretion of the treating clinician or study investigator * People with a risk for psychosis, mania, and alcohol abuse, based on screening questions commonly used in the field * Cannot attend the intervention activities at the hospital during the proposed intervention period
Where this trial is running
Can Tho and 5 other locations
- Can Tho Oncology Hospital — Can Tho, Vietnam (Recruiting)
- Oncology Center, Cho Ray Hospital — Chợ Rây, Vietnam (Recruiting)
- Da Nang Oncology Hospital — Da Nang, Vietnam (Recruiting)
- Breast and Gynecology Department, Hung Vuong Women's Hospital — Ho Chi Minh City, Vietnam (Recruiting)
- Ho Chi Minh City Oncology Hospital — Ho Chi Minh City, Vietnam (Recruiting)
- Oncology Center, Hue Central Hospital — Huế, Vietnam (Recruiting)
Study contacts
- Principal investigator: Phuongthao Le, PhD — Boston University
- Study coordinator: Phuongthao Le, PhD
- Email: ptle@bu.edu
- Phone: 617 358 1342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.