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Spots Global Cancer Trial Database for Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam

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Trial Identification

Brief Title: 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

Study ID: NCT06398067

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Can Tho Oncology Hospital, Can Tho, , Vietnam

Oncology Center, Cho Ray Hospital, Cho Ray, , Vietnam

Da Nang Oncology Hospital, Da Nang, , Vietnam

Hanoi Oncology Hospital, Hanoi, , Vietnam

National Cancer Hospital (K3), Hanoi, , 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

Contact Details

Name: Phuongthao Le, PhD

Affiliation: Boston University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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