Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-27
Brief Title:
Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
A Pilot Randomized Controlled Trial of Self-Help Plus Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K01TW012174 | NIH | None | httpsreporternihgovquickSearchK01TW012174 |