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

Last updated: November 11, 2024
Sponsor: Boston University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Pelvic Cancer

Vaginal Cancer

Treatment

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

Vietnamese Self-Help Plus (vSH+)

Clinical Study ID

NCT06398067
H-44411
K01TW012174
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 years or older

  • Have a clinician-confirmed diagnosis within the past 12 months of first-time breastand/or gynecologic cancer (e.g., cervical, ovarian, uterine, vaginal, vulvar) instages I-III

  • Currently or will receive treatment with curative intent

  • Score less than 8 on the National Comprehensive Cancer Network (NCCN) DistressThermometer, indicating low to moderate levels of distress

  • Score less than 15 on the Patient Health Questionnaire-9 items (PHQ-9, indicatinglow to moderate levels of depression

Exclusion

Exclusion Criteria:

  • Selected '2 Several days' or '3 Almost everyday' on PHQ9 item #9, indicatingindicating imminent risk of suicide

  • Have severe chronic diseases (e.g., coronary heart disease, chronic obstructivepulmonary disease (COPD), chronic renal failure), at the discretion of the treatingclinician or study investigator

  • People with a risk for psychosis, mania, and alcohol abuse, based on screeningquestions commonly used in the field

  • Cannot attend the intervention activities at the hospital during the proposedintervention period

Study Design

Total Participants: 285
Treatment Group(s): 2
Primary Treatment: 'Doing What Matters in Times of Stress' (DWM) Guide
Phase:
Study Start date:
November 05, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Can Tho Oncology Hospital

    Can Tho,
    Vietnam

    Active - Recruiting

  • Oncology Center, Cho Ray Hospital

    Cho Ray,
    Vietnam

    Active - Recruiting

  • Da Nang Oncology Hospital

    Da Nang,
    Vietnam

    Active - Recruiting

  • Hanoi Oncology Hospital

    Hanoi,
    Vietnam

    Site Not Available

  • National Cancer Hospital (K3)

    Hanoi,
    Vietnam

    Site Not Available

  • Breast and Gynecology Department, Hung Vuong Women's Hospital

    Ho Chi Minh,
    Vietnam

    Active - Recruiting

  • Ho Chi Minh City Oncology Hospital

    Ho Chi Minh,
    Vietnam

    Active - Recruiting

  • Oncology Center, Hue Central Hospital

    Hue,
    Vietnam

    Active - Recruiting

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