NCT06398067 Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
| NCT ID | NCT06398067 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 285 participants |
| Start Date | 2024-11-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 285 participants in total. It began in 2024-11-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Phuongthao Le, PhD
PRINCIPAL INVESTIGATOR
Boston University
Frequently Asked Questions
Who can join the NCT06398067 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06398067 currently recruiting?
Yes, NCT06398067 is actively recruiting participants. Contact the research team at ptle@bu.edu for enrollment information.
Where is the NCT06398067 trial being conducted?
This trial is being conducted at Can Tho, Vietnam, Chợ Rây, Vietnam, Da Nang, Vietnam, Ho Chi Minh City, Vietnam and 2 additional locations.
Who is sponsoring the NCT06398067 clinical trial?
NCT06398067 is sponsored by Boston University. The principal investigator is Phuongthao Le, PhD at Boston University. The trial plans to enroll 285 participants.
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