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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Gynecologic Cancer
• Intervention / Treatment: Behavioral: Vietnamese Self-Help Plus (vSH+); Other: 'Doing What Matters in Times of Stress' (DWM) Guide

• Study Type: Interventional
• Enrollment (Estimated): 285
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Phuongthao Le, PhD; Phone Number: 617 358 1342; Email: ptle@bu.edu

Study Locations

• Vietnam
  • Can Tho, Vietnam
    • Recruiting
    • Can Tho Oncology Hospital
  • Chợ Rây, Vietnam
    • Recruiting
    • Oncology Center, Cho Ray Hospital
  • Da Nang, Vietnam
    • Recruiting
    • Da Nang Oncology Hospital
  • Ho Chi Minh City, Vietnam
    • Recruiting
    • Ho Chi Minh City Oncology Hospital
  • Ho Chi Minh City, Vietnam
    • Recruiting
    • Breast and Gynecology Department, Hung Vuong Women's Hospital
  • Huế, Vietnam
    • Recruiting
    • Oncology Center, Hue Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vietnamese Self-Help Plus (vSH+); 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).	Behavioral: Vietnamese 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.
Active Comparator: Enhanced Usual Care; Participants randomized into this arm will receive usual care and a copy of the illustrated guide, 'Doing What Matters inn Times of STress' (DWM).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in severity of depression	The Patient Health Questionnaire-9 items (PHQ-9) is a 9 item questionnaire with each item scored from 0 to 3. Scores can range from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).	Baseline, 1 month, 3 months
Change in Anxiety	The Generalized Anxiety Disorder-7 items Scale (GAD-7) is a 7 item instrument with each item scored between 0 and 3 where 0=not at all, and 3= nearly every day. Scores can range from 0 to 21 and are interpreted as-- scores 0-4: Minimal Anxiety, scores 5-9: Mild Anxiety, scores 10-14: Moderate Anxiety, and scores greater than 15: Severe Anxiety.	Baseline, 1 month, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in general quality of life	General quality of life will be assessed using the EuroQol 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L). The five dimensions include: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension is rated at five different levels from no problems to the most extreme problems. The questionnaire also includes a visual analog scale asking respondents to rate their current health from 0 (worst health imaginable) to 100 (best health imaginable)	Baseline,1 month, 3 months
Change in quality of life related to cancer patients' health	Quality of life related to cancer patients' health will be measured using the Functional Assessment of Cancer Therapy - General, version 4 (FACT-G). This questionnaire includes 27 questions to evaluate 4 domains: physical, social/family, emotional, and functional. Each question is rated on a scale from 0 (not at all) to 4 (very much) based on the patient's experience over the last 7 days.	Baseline, 1 month, 3 months
Change in cancer coping	Cancer coping will be measured using the Mini-Mental Adjustment to Cancer Scale (Mini-MAC). It consists of five scales: helpless/hopeless, anxious preoccupation, fighting spirit, cognitive avoidance, and fatalism. It has 29 tems on a 4-point Likert scale: 1 (definitely does not apply) to 4 (definitely applies).	Baseline, 1 month, 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological flexibility (Mediator)	Mediation analyses will evaluate psychological flexibility, measured by the Acceptance and Action Questionnaire-II (AAQ-2), which is the intended mechanism targeted by SH+. The AAQ2 has 7 items on a 7-point Likert scale: 1 (never true) to 7 (always true).	Baseline, 1 month, 3 months
Social support (moderator)	Moderation analyses will evaluate social support, assessed with the Medical Outcomes Study Social Support Survey 19 items (MOS-SSS). It assesses four domains of perceived social support: tangible support, emotional-information support, positive social interactions, and affectionate support. Likert response scale range from 1 (none of the time) to 5 (all of the time).	Baseline, 1 month, 3 months

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Phuongthao Le, PhD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 27, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Stress management; Viet Nam; World Health Organization; Self-Help Plus (SH+)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: H-44411; K01TW012174 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No