Stress management for breast and gynecologic cancer patients in Vietnam

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.