Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam

NCT06398067 | Recruiting

• 2 other identifiers: H-44411K01TW012174
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer; Gynecologic Cancer

Keywords

Self-Help Plus (SH+); Stress management; Viet Nam; World Health Organization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in general quality of life

  Baseline,1 month, 3 months

• Change in quality of life related to cancer patients' health

  Baseline, 1 month, 3 months

• Change in cancer coping

  Baseline, 1 month, 3 months

Other Outcomes (2)

• Psychological flexibility (Mediator)

  Baseline, 1 month, 3 months

• Social support (moderator)

  Baseline, 1 month, 3 months

Study Arms (2)

Vietnamese Self-Help Plus (vSH+)

EXPERIMENTAL

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+); Other: 'Doing What Matters in Times of Stress' (DWM) Guide

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

Vietnamese Self-Help Plus (vSH+) BEHAVIORAL

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').

Vietnamese Self-Help Plus (vSH+)

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

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.

Enhanced Usual Care; Vietnamese Self-Help Plus (vSH+)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (6)

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

Related Publications (1)

• Le 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Phuongthao Le, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phuongthao Le, PhD

CONTACT

617 358 1342; ptle@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 2-arm, parallel, single-blind randomized controlled trial (RCT).

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 3, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (6)