Condition: Breast Cancer · Gynecologic Cancer · Sponsor: Boston University
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.
Phuongthao Le, PhD · 617 358 1342 · ptle@bu.edu
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| 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 |
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Source record: clinicaltrials.gov/study/NCT06398067