Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors

Breast Neoplasm Female Clinical Trial

Official title:

Somatic Acupressure on Fatigue-sleep Disturbance-depression Symptom Cluster in Breast Cancer Survivors: a Phase III Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412107
• Other study ID #: H22110
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Charles Darwin University
• Contact: Meng-Yuan Li, PhDc
• Phone: (61)472663736
• Email: mengyuanli[@]students.cdu.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Symptom Cluster
• Syndrome

Intervention

Other:
• True acupressure
Participants will receive a 7-week true self-acupressure practice and a 12-week follow-up.
• Sham acupressure
Participants will receive a 7-week sham self-acupressure practice and a 12-week follow-up.
• Usual care
Routine methods of treatment and care along with an updated education booklet.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Charles Darwin University	Second Affiliated Hospital of Zunyi Medical University, The Affiliated Hospital Of Southwest Medical University, Zunyi Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	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.	Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Primary	Sleep disturbance	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.	Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Primary	Depression	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	Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Primary	Symptom cluster assessment: fatigue	The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess fatigue.	Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Primary	Symptom cluster assessment: sleep disturbance	The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess sleep disturbance.	Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Primary	Symptom cluster assessment: depression	The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess depression.	Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Secondary	Patients' Quality of life	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.	Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Secondary	Safety: adverse events	Adverse events will be collected through regular contact between the participant and the research assistant across the intervention period.	The adverse event will be assessed once it occurs during the study period, from the baseline to the end of 7 weeks.
Secondary	Economic evaluation	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.	Weekly data collected across the 19 weeks.