Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors
- Conditions
- Breast Neoplasm FemaleSymptom Cluster
- Interventions
- Other: Usual careOther: True acupressureOther: Sham acupressure
- Registration Number
- NCT06412107
- Lead Sponsor
- Charles Darwin University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 108
- Diagnosed with early-stage female BC without distant metastases (from stage I to IIIa).
- 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.
- Had completed chemotherapy for at least one month and up to three years (to capture persistent symptoms)
- Have no scheduled chemotherapy or radiotherapy during the study.
- Be willing to participate in this study and consent in writing.
- Currently using pharmaceutical drugs (e.g., antidepressant medications or hypnotics) to treat symptoms of fatigue, sleep disturbance, or depression.
- Inability (or difficulty) in following the study procedures and instructions due to being extremely weak and/or cognitively impaired.
- Received any type of somatic acupressure interventions during the past six months.
- Currently involved in any other studies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care group Usual care Routine methods of treatment and care. Sham acupressure group Usual care Same dose as the true acupressure group but on the sham acupoints plus routine methods of treatment and care. True acupressure group Usual care True self-acupressure plus routine methods of treatment and care. True acupressure group True acupressure True self-acupressure plus routine methods of treatment and care. Sham acupressure group Sham acupressure Same dose as the true acupressure group but on the sham acupoints plus routine methods of treatment and care.
- Primary Outcome Measures
Name Time Method Depression Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3) The Hospital Anxiety and Depression Scale-Depression (HADS-D; 7 items; score range 0-21) will be used for evaluating depression. A higher score indicating greater severity of depression
Symptom cluster assessment: fatigue Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3) The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess fatigue.
Symptom cluster assessment: sleep disturbance Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3) The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess sleep disturbance.
Fatigue Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3) The Brief Fatigue Inventory (BFI; 9 items) will be used to measure the participants' fatigue, with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." The global score for the BFI is calculated as the mean value of these 9 items. A higher score indicates greater severity of fatigue.
Sleep disturbance Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3) The Pittsburgh Sleep Quality Index (PSQI; 19 items) will be used to assess sleep disturbance. A global (total) score is obtained from the sum of the seven component scores, with a possible range of 0 to 21 points. A higher total score indicates poorer sleep quality.
Symptom cluster assessment: depression Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3) The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess depression.
- Secondary Outcome Measures
Name Time Method Safety: adverse events The adverse event will be assessed once it occurs during the study period, from the baseline to the end of 7 weeks. Adverse events will be collected through regular contact between the participant and the research assistant across the intervention period.
Economic evaluation Weekly data collected across the 19 weeks. A within-trial economic evaluation will be conducted whereby clinical outcomes (fatigue-sleep disturbance-depression symptom cluster and quality of life) and cost data will be compared between the true intervention group and the usual care group over 19 weeks. Data on economic-related resource use will be captured using a bespoke questionnaire over 19 weeks from randomization.
Patients' Quality of life Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3) The Functional Assessment of Cancer Therapy-Breast (FACT-B; 37 items) will be used for assessing the Patients' Quality of life. A summing-up of each FACT-B subscale creates the FACT-B total score, ranging from 0 to 148. A higher score indicates a better Quality of life.
Trial Locations
- Locations (2)
The Second Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China
The Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China