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

Not Applicable

Recruiting

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

• Registration Number: NCT06398067
• Lead Sponsor: Boston University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-27
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-03
• Status Verified: 2024-11
• Study Start: 2024-11-05
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 285

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vietnamese Self-Help Plus (vSH+)	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).
Vietnamese Self-Help Plus (vSH+)	'Doing What Matters in Times of Stress' (DWM) Guide	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).
Enhanced Usual Care	'Doing What Matters in Times of Stress' (DWM) Guide	Participants randomized into this arm will receive usual care and a copy of the illustrated guide, 'Doing What Matters inn Times of STress' (DWM).

Primary Outcome Measures

Name	Time	Method
Change in severity of depression	Baseline, 1 month, 3 months	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).
Change in Anxiety	Baseline, 1 month, 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in general quality of life	Baseline,1 month, 3 months	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)
Change in quality of life related to cancer patients' health	Baseline, 1 month, 3 months	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.
Change in cancer coping	Baseline, 1 month, 3 months	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).

Trial Locations

Locations (6)

Can Tho Oncology Hospital; 🇻🇳 Can Tho, Vietnam

Oncology Center, Cho Ray Hospital; 🇻🇳 Cho Ray, Vietnam

Da Nang Oncology Hospital; 🇻🇳 Da Nang, Vietnam

Breast and Gynecology Department, Hung Vuong Women's Hospital; 🇻🇳 Ho Chi Minh, Vietnam

Ho Chi Minh City Oncology Hospital; 🇻🇳 Ho Chi Minh, Vietnam

Oncology Center, Hue Central Hospital; 🇻🇳 Hue, Vietnam