Breast CancerNCT06398067
Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
A study testing Vietnamese Self-Help Plus (vSH+) and 'Doing What Matters in Times of Stress' (DWM) Guide in people with Breast Cancer and Gynecologic Cancer, run by Boston University at 6 sites in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer
- What is being tested?
- Vietnamese Self-Help Plus (vSH+) and 'Doing What Matters in Times of Stress' (DWM) Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 6 sitesVietnam
- Study dates
- 5 Nov 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Vietnam6 sites, 6 recruiting
- Recruiting
Can Tho Oncology Hospital
Can Tho
- Recruiting
Oncology Center, Cho Ray Hospital
Chợ Rây
- Recruiting
Da Nang Oncology Hospital
Da Nang
- Recruiting
Breast and Gynecology Department, Hung Vuong Women's Hospital
Ho Chi Minh City
- Recruiting
Ho Chi Minh City Oncology Hospital
Ho Chi Minh City
- Recruiting
Oncology Center, Hue Central Hospital
Huế
About this study
Official title: A Pilot Randomized Controlled Trial of Self-Help Plus Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
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.
Read more
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.
- Conditions
- Breast Cancer, Gynecologic Cancer
- Being tested
- Vietnamese Self-Help Plus (vSH+), 'Doing What Matters in Times of Stress' (DWM) Guide
- Keywords
- Self-Help Plus (SH+), Stress management, Viet Nam, World Health Organization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vietnamese Self-Help Plus (vSH+)Behavioural
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').
'Doing What Matters in Times of Stress' (DWM) GuideOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vietnamese Self-Help Plus (vSH+) | Experimental | 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). Receives: Behavioral: Vietnamese Self-Help Plus (vSH+); Other: 'Doing What Matters in Times of Stress' (DWM) Guide |
| Enhanced Usual Care | Active comparator | Participants randomized into this arm will receive usual care and a copy of the illustrated guide, 'Doing What Matters inn Times of STress' (DWM). Receives: Other: 'Doing What Matters in Times of Stress' (DWM) Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of depression
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).
Measured: Baseline, 1 month, 3 months
Change in Anxiety
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.
Measured: Baseline, 1 month, 3 months
Secondary outcomes (3)
Change in general quality of life
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)
Measured: Baseline,1 month, 3 months
Change in quality of life related to cancer patients' health
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.
Measured: Baseline, 1 month, 3 months
Change in cancer coping
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).
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start5 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 2-arm, parallel, single-blind randomized controlled trial (RCT).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Phuongthao Le, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398067
- Sponsor's protocol ID
- H-44411
- Other IDs
- K01TW012174
- Status last verified
- Nov 2025
- First submitted
- 27 Apr 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 gynaecological cancer in Viet Nam: a study protocol. BMJ Open. 2025 Dec 17;15(12):e106185. doi: 10.1136/bmjopen-2025-106185.
PubMed 41407411
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of Self-Help Plus Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
- ClinicalTrials.gov ID
- NCT06398067
- Acronym / sponsor ID
- H-44411
- Conditions
- Breast Cancer, Gynecologic Cancer
- Keywords
- Self-Help Plus (SH+), Stress management, Viet Nam, World Health Organization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A 2-arm, parallel, single-blind randomized controlled trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Vietnamese Self-Help Plus (vSH+) | Experimental | Behavioral: Vietnamese Self-Help Plus (vSH+), Other: 'Doing What Matters in Times of Stress' (DWM) GuideParticipants 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 | Active comparator | Other: 'Doing What Matters in Times of Stress' (DWM) GuideParticipants randomized into this arm will receive usual care and a copy of the illustrated guide, 'Doing What Matters inn Times of STress' (DWM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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'). | Behavioural | Vietnamese Self-Help Plus (vSH+) |
| 'Doing What Matters in Times of Stress' (DWM) GuideAn 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. | Other | Enhanced Usual Care, Vietnamese Self-Help Plus (vSH+) |
Primary outcome
Change in severity of depression
Time frame: 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
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Derived from this study: PubMed 41407411Le 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 gynaecological cancer in Viet Nam: a study protocol. BMJ Open. 2025 Dec 17;15(12):e106185. doi: 10.1136/bmjopen-2025-106185.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phuongthao Le, PhD principal investigator
Boston University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vietnamese Self-Help Plus (vSH+) and 'Doing What Matters in Times of Stress' (DWM) Guide in people with Breast Cancer and Gynecologic Cancer, run by Boston University at 6 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phuongthao Le, PhD (617 358 1342, ptle@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of depression (time frame: Baseline, 1 month, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06398067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.