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Study identifier: NCT06398067 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam

Condition: Breast Cancer · Gynecologic Cancer  ·  Sponsor: Boston University

PhaseNA
Planned participants285
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Phuongthao Le, PhD  ·  617 358 1342  ·  ptle@bu.edu

Always discuss trial participation with your own doctor first.

Locations (6)

Can Tho Oncology HospitalCan Tho, VietnamRecruiting
Oncology Center, Cho Ray HospitalChợ Rây, VietnamRecruiting
Da Nang Oncology HospitalDa Nang, VietnamRecruiting
Breast and Gynecology Department, Hung Vuong Women's HospitalHo Chi Minh City, VietnamRecruiting
Ho Chi Minh City Oncology HospitalHo Chi Minh City, VietnamRecruiting
Oncology Center, Hue Central HospitalHuế, VietnamRecruiting

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Source record: clinicaltrials.gov/study/NCT06398067