Clinical trial · Interventional
Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
A Pilot Randomized Controlled Trial of Self-Help Plus Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 'Doing What Matters in Times of Stress' (DWM) Guide | Other | — | UNRESOLVED |
| Vietnamese Self-Help Plus (vSH+) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vietnamese Self-Help Plus (vSH+)
- description
- Participants randomized into this arm will attend information sessions and receive the Vietnamese Self-Help Plus (vSH+) intervention and a copy of the illustrated guide, 'Doing What Matters inn Times of STress' (DWM).
- interventionNames
- Behavioral: Vietnamese Self-Help Plus (vSH+)
- Other: 'Doing What Matters in Times of Stress' (DWM) Guide
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care
- description
- Participants randomized into this arm will receive usual care and a copy of the illustrated guide, 'Doing What Matters inn Times of STress' (DWM).
- interventionNames
- Other: 'Doing What Matters in Times of Stress' (DWM) Guide
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLe PD, Nguyen NB, Dang ATT, Tran LTK, Pham HN, Le TA, Vo KV, Nguyen HT, Hoang DT, Phan DC, Nguyen CBT, Nguyen MHT, Nguyen QH, Phan HNT, Dang TQ, Nguyen HT, Le DD, Phan THT, Nguyen PTN, Nguyen VT, Tran PT, Pham AN, Vom Eigen K, Campbell R, Taylor C, Tran HTT, Hoang MV. Pilot randomised controlled trial of the self-help plus stress management intervention among patients with breast and gynaecological cancer in Viet Nam: a study protocol. BMJ Open. 2025 Dec 17;15(12):e106185. doi: 10.1136/bmjopen-2025-106185. PMID 41407411