Actively Recruiting
Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
Led by Boston University · Updated on 2025-11-17
285
Participants Needed
6
Research Sites
108 weeks
Total Duration
On this page
Sponsors
B
Boston University
Lead Sponsor
F
Fogarty International Center of the National Institute of Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Psychological distress is common among Vietnamese cancer patients but often underestimated and not detected by professionals due to lack of time and overload of clinical work. Currently no established, evidence-based intervention exists to help address the mental health needs of cancer patients in Viet Nam besides the 'Stronger Together' peer mentoring intervention model that the investigators piloted in 2021-2023. The goal of this 2-arm, parallel, single-blind randomized controlled trial (RCT) is to pilot and evaluate the Vietnamese Self Help Plus (vSH+) stress management intervention among breast and gynecologic cancer patients in Viet Nam. Aim 1- the investigators pilot the adapted vSH+ intervention. After recruitment and screening, participants are randomized into either the intervention (vSH+) or enhanced usual care (EUC) study arms. Participants are invited to attend an in-person informational session (IS) specific to their study arm, where informed consent is obtained. Aim 2- the investigators assess the potential effectiveness of the vSH+ intervention. Quantitative surveys of study outcomes measures are administered at three timepoints: T0 (baseline, in-person, during info-sessions); T1 (1-2 weeks post-intervention, via phone); and T2 (3 months post-intervention, via phone). Aim 3- the investigators conduct a qualitative process evaluation, via in-depth interview (IDIs) and focus group discussions (FGDs), to assess the acceptability and feasibility implementing and scaling up the vSH+ intervention model. Satisfaction surveys will be administered during vSH+ sessions and in-depth interviews (IDIs) will be conducted following the conclusion of the intervention. IDIs wil also be conducted with Facilitators, in addition to evaluation surveys during vSH+ sessions and supportive supervision sessions. Between T1 and T2, the investigators will conduct IDIs with Healthcare Workers and focus group discussions with Caregivers.
CONDITIONS
Official Title
Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Clinician-confirmed diagnosis within past 12 months of first-time breast and/or gynecologic cancer (stages I-III)
- Currently receiving or will receive treatment with curative intent
- Score less than 8 on the NCCN Distress Thermometer indicating low to moderate distress
- Score less than 15 on the PHQ-9 indicating low to moderate depression
You will not qualify if you...
- Selected '2 Several days' or '3 Almost everyday' on PHQ-9 item #9 indicating imminent suicide risk
- Have severe chronic diseases such as coronary heart disease, COPD, or chronic renal failure
- Risk for psychosis, mania, or alcohol abuse based on screening questions
- Unable to attend intervention activities at the hospital during the intervention period
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Can Tho Oncology Hospital
Can Tho, Vietnam
Actively Recruiting
2
Oncology Center, Cho Ray Hospital
Chợ Rây, Vietnam
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3
Da Nang Oncology Hospital
Da Nang, Vietnam
Actively Recruiting
4
Breast and Gynecology Department, Hung Vuong Women's Hospital
Ho Chi Minh City, Vietnam
Actively Recruiting
5
Ho Chi Minh City Oncology Hospital
Ho Chi Minh City, Vietnam
Actively Recruiting
6
Oncology Center, Hue Central Hospital
Huế, Vietnam
Actively Recruiting
Research Team
P
Phuongthao Le, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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