Clinical trial NCT06398067: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Gynecologic Cancer
Keywords: Self-Help Plus (SH+)
Stress management
Viet Nam
World Health Organization
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2024-05-03
Enrollment: 285
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2-arm, parallel, single-blind randomized controlled trial (RCT).
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in severity of depression
timeFrame: Baseline, 1 month, 3 months
measure: Change in Anxiety
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
measure: Change in general quality of life
timeFrame: Baseline,1 month, 3 months
measure: Change in quality of life related to cancer patients' health
timeFrame: Baseline, 1 month, 3 months
measure: Change in cancer coping
timeFrame: Baseline, 1 month, 3 months
Other outcomes:
measure: Psychological flexibility (Mediator)
timeFrame: Baseline, 1 month, 3 months
measure: Social support (moderator)
timeFrame: Baseline, 1 month, 3 months
Locations:
city: Can Tho
country: Vietnam
facility: Can Tho Oncology Hospital
city: Cho Ray
country: Vietnam
facility: Oncology Center, Cho Ray Hospital
city: Da Nang
country: Vietnam
facility: Da Nang Oncology Hospital
city: Ho Chi Minh
country: Vietnam
facility: Breast and Gynecology Department, Hung Vuong Women's Hospital
city: Ho Chi Minh
country: Vietnam
facility: Ho Chi Minh City Oncology Hospital
city: Hue
country: Vietnam
facility: Oncology Center, Hue Central Hospital
Study officials:
affiliation: Boston University
name: Phuongthao Le, PhD
role: PRINCIPAL_INVESTIGATOR
References: