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

Official title

A Pilot Randomized Controlled Trial of Self-Help Plus Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam

Overview

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.

Interventions

• 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.

Primary outcome measures

• Change in severity of depression [Time frame: Baseline, 1 month, 3 months]
• Change in Anxiety [Time frame: Baseline, 1 month, 3 months]

Secondary outcome measures (3)

• Change in general quality of life [Time frame: Baseline,1 month, 3 months]
• Change in quality of life related to cancer patients' health [Time frame: Baseline, 1 month, 3 months]
• Change in cancer coping [Time frame: Baseline, 1 month, 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Vietnam · 6 centers

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

Publications

• 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 gynaecologica PMID 41407411

Identifiers

NCT: NCT06398067 · H-44411 · K01TW012174

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗