Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412107
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-26
Brief Title:
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors
Sponsor:
Charles Darwin University
Organization:
Charles Darwin University
Study Overview
Official Title:
Somatic Acupressure on Fatigue-sleep Disturbance-depression Symptom Cluster in Breast Cancer Survivors a Phase III Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This study is designed following the updated Medical Research Council MRC Framework for Developing and Evaluating Complex Interventions The goal of this randomized controlled trial RCT is to evaluate the effects safety and cost-effectiveness of an evidence-based somatic acupressure SA intervention on the fatigue-sleep disturbance-depression symptom cluster and quality of life among breast cancer survivors
Detailed Description:
Fatigue sleep disturbance and depression commonly co-occur in breast cancer BC survivors forming a significant cluster known as the fatigue-sleep disturbance-depression symptom cluster FSDSC The FSDSC correlates notably with decreased everyday functioning and quality of life QoL Currently there are no targeted pharmacological interventions available for alleviating the FSDSC in BC survivors Additionally concerns arise regarding the risks of drug-related adverse events and potential interactions with ongoing antineoplastic regimens when relying solely on pharmacological treatments Consequently nonpharmacological adjunct interventions have emerged as an alternative method Somatic acupressure SA presents a promising nonpharmacological intervention for managing the FSDSC due to its advantages including self-administration with minimal effort and time lower cost good tolerability and minimal instruction required from clinical staff However the effectiveness of SA in improving the FSDSC in BC survivors remains uncertain The proposed study follows the Medical Research Council MRC Framework for Developing and Evaluating Complex Intervention the MRC Framework to develop an evidence-based SA protocol to help with the better management of the FSDSC in BC survivors The first phase identified and validated the most effective acupoint formula with the optimal SA duration and frequency based on multiple evidence bases Subsequently a well-designed phase II randomized controlled trial RCT was conducted It demonstrated the feasibility of an evidence-based SA intervention protocol and its potentially positive effects on the FSDSC in BC survivors The encouraging results therefore warrant further investigation through a large-scale RCT to ascertain the effects of SA on the FSDSC among BC survivors The whole program is designed following the MRC Framework Hence the current study aims to evaluate the effects safety and cost-effectiveness of the SA protocol for managing the FSDSC in BC survivors through a phase III RCT
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