Clinical trial NCT06412107: Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors
Official title: Somatic Acupressure on Fatigue-sleep Disturbance-depression Symptom Cluster in Breast Cancer Survivors: a Phase III Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasm Female
Symptom Cluster
Keywords: cancer
acupressure
fatigue
depression
insomnia
Lead sponsor: Charles Darwin University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Zunyi Medical University
name: Zunyi Medical College
First posted: 2024-05-14
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Fatigue
timeFrame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
measure: Sleep disturbance
timeFrame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
measure: Depression
timeFrame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
measure: Symptom cluster assessment: fatigue
timeFrame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
measure: Symptom cluster assessment: sleep disturbance
timeFrame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
measure: Symptom cluster assessment: depression
timeFrame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Secondary outcomes:
measure: Patients' Quality of life
timeFrame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
measure: Safety: adverse events
timeFrame: The adverse event will be assessed once it occurs during the study period, from the baseline to the end of 7 weeks.
measure: Economic evaluation
timeFrame: Weekly data collected across the 19 weeks.
Other outcomes:
Locations:
city: Zunyi
country: China
facility: The Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Zunyi
country: China
facility: The Second Affiliated Hospital of Zunyi Medical University
state: Guizhou
Study officials:
affiliation: Charles Darwin University
name: Tao Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: