Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors

May 13, 2024 updated by: Charles Darwin University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: True acupressure group
True self-acupressure plus routine methods of treatment and care.
Other: True acupressure
Participants will receive a 7-week true self-acupressure practice and a 12-week follow-up.
Other: Usual care
Routine methods of treatment and care along with an updated education booklet.
Sham Comparator: Sham acupressure group
Same dose as the true acupressure group but on the sham acupoints plus routine methods of treatment and care.
Other: Sham acupressure
Participants will receive a 7-week sham self-acupressure practice and a 12-week follow-up.
Other: Usual care
Routine methods of treatment and care along with an updated education booklet.
Other: Usual care group
Routine methods of treatment and care.
Other: Usual care
Routine methods of treatment and care along with an updated education booklet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: 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.
Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Sleep disturbance
Time Frame: 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.
Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Depression
Time Frame: 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
Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Symptom cluster assessment: fatigue
Time Frame: 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.
Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Symptom cluster assessment: sleep disturbance
Time Frame: 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.
Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Symptom cluster assessment: depression
Time Frame: 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.
Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' Quality of life
Time Frame: 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.
Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Safety: adverse events
Time Frame: 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.
The adverse event will be assessed once it occurs during the study period, from the baseline to the end of 7 weeks.
Economic evaluation
Time Frame: 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.
Weekly data collected across the 19 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles Darwin University

Collaborators

The Affiliated Hospital Of Southwest Medical University
Zunyi Medical College
Second Affiliated Hospital of Zunyi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

May 12, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H22110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasm Female

Clinical Trials on True acupressure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe