Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors

Trial Title: Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors

NCT ID: NCT06412107

Condition: Breast Neoplasm Female
Symptom Cluster

Conditions: Official terms:
Breast Neoplasms
Syndrome

Conditions: Keywords:
cancer
acupressure
fatigue
depression
insomnia

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Masking description: This study can achieve a partial blind design for participants in the true and sham acupressure groups. Blind of outcome assessment will be also achieved in the true and sham intervention groups as all the questionnaires are patient-reported and the participants themselves will be the outcome assessors. Data analysis will be conducted by an independent statistician who are blinded to the group allocation.

Intervention:

Intervention type: Other
Intervention name: True acupressure
Description: Participants will receive a 7-week true self-acupressure practice and a 12-week follow-up.
Arm group label: True acupressure group

Intervention type: Other
Intervention name: Sham acupressure
Description: Participants will receive a 7-week sham self-acupressure practice and a 12-week follow-up.
Arm group label: Sham acupressure group

Intervention type: Other
Intervention name: Usual care
Description: Routine methods of treatment and care along with an updated education booklet.
Arm group label: Sham acupressure group
Arm group label: True acupressure group
Arm group label: Usual care group

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Diagnosed with early-stage female BC without distant metastases (from stage I to IIIa). 2. Have experienced at least moderate FSDSC with a score of ≥4 on an 0-10 point Numeric Rating Scale (0= 'no symptom',10= 'worst symptom') for fatigue, sleep disturbance and depression during the past month. 3. Had completed chemotherapy for at least one month and up to three years (to capture persistent symptoms) 4. Have no scheduled chemotherapy or radiotherapy during the study. 5. Be willing to participate in this study and consent in writing. Exclusion Criteria: 1. Currently using pharmaceutical drugs (e.g., antidepressant medications or hypnotics) to treat symptoms of fatigue, sleep disturbance, or depression. 2. Inability (or difficulty) in following the study procedures and instructions due to being extremely weak and/or cognitively impaired. 3. Received any type of somatic acupressure interventions during the past six months. 4. Currently involved in any other studies.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: The Affiliated Hospital of Zunyi Medical University

Address:
City: Zunyi
Country: China

Status: Recruiting

Contact:
Last name: Renli Deng

Start date: May 20, 2024

Completion date: June 2025

Lead sponsor:
Agency: Charles Darwin University
Agency class: Other

Collaborator:
Agency: Second Affiliated Hospital of Zunyi Medical University
Agency class: Other

Collaborator:
Agency: Zunyi Medical College
Agency class: Other

Source: Charles Darwin University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06412107