RecruitingNot ApplicableNCT06398067

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


Sponsor

Boston University

Enrollment

285 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a culturally adapted stress management program for women in Vietnam diagnosed with breast or gynecologic cancers, to help them cope with anxiety, depression, and treatment-related distress. **You may be eligible if...** - You are a woman diagnosed with breast cancer or a gynecologic cancer (ovarian, cervical, uterine, etc.) - You are currently receiving treatment or recently completed treatment - You are experiencing significant stress, anxiety, or depression - You live in Vietnam and can participate in the program sessions **You may NOT be eligible if...** - You have severe psychiatric illness that requires immediate specialized care - You are in active suicidal crisis - You are unable to communicate in Vietnamese - You are unable to attend the required sessions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALVietnamese Self-Help Plus (vSH+)

vSH+ is a stress management program delivered through four 75-minute sessions. It includes the five core SH+ skills. Healthcare workers (nurses and social workers) function as lead facilitators (called 'HW Facilitators') and cancer survivors as co-facilitators (called 'Peer Facilitators').

OTHER'Doing What Matters in Times of Stress' (DWM) Guide

An illustrated guide developed by WHO to equip people with practical skills to help cope with stress which has been translated to Vietnamese and reviewed and revised by the investigators.


Locations(6)

Can Tho Oncology Hospital

Can Tho, Vietnam

Oncology Center, Cho Ray Hospital

Chợ Rây, Vietnam

Da Nang Oncology Hospital

Da Nang, Vietnam

Breast and Gynecology Department, Hung Vuong Women's Hospital

Ho Chi Minh City, Vietnam

Ho Chi Minh City Oncology Hospital

Ho Chi Minh City, Vietnam

Oncology Center, Hue Central Hospital

Huế, Vietnam

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NCT06398067


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