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

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

NCT ID: NCT06398067

Condition: Breast Cancer
Gynecologic Cancer

Conditions: Keywords:
Self-Help Plus (SH+)
Stress management
Viet Nam
World Health Organization

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: A 2-arm, parallel, single-blind randomized controlled trial (RCT).

Primary purpose: Prevention

Masking: Single (Participant)

Intervention:

Intervention type: Behavioral
Intervention name: Vietnamese Self-Help Plus (vSH+)
Description: 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').
Arm group label: Vietnamese Self-Help Plus (vSH+)

Intervention type: Other
Intervention name: 'Doing What Matters in Times of Stress' (DWM) Guide
Description: 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.
Arm group label: Enhanced Usual Care
Arm group label: Vietnamese Self-Help Plus (vSH+)

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.

Criteria for 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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Can Tho Oncology Hospital

Address:
City: Can Tho
Country: Vietnam

Status: Recruiting

Facility:
Name: Oncology Center, Cho Ray Hospital

Address:
City: Cho Ray
Country: Vietnam

Status: Recruiting

Facility:
Name: Da Nang Oncology Hospital

Address:
City: Da Nang
Country: Vietnam

Status: Recruiting

Facility:
Name: Breast and Gynecology Department, Hung Vuong Women's Hospital

Address:
City: Ho Chi Minh
Country: Vietnam

Status: Recruiting

Facility:
Name: Ho Chi Minh City Oncology Hospital

Address:
City: Ho Chi Minh
Country: Vietnam

Status: Recruiting

Facility:
Name: Oncology Center, Hue Central Hospital

Address:
City: Hue
Country: Vietnam

Status: Recruiting

Start date: November 5, 2024

Completion date: December 2026

Lead sponsor:
Agency: Boston University
Agency class: Other

Collaborator:
Agency: Fogarty International Center of the National Institute of Health
Agency class: NIH

Source: Boston University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06398067