Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients

Cancer Clinical Trial

Official title:

Development and Preliminary Evaluation of an Evidence-based Somatic Acupressure Protocol for the Self-management of Symptom Cluster of Fatigue, Insomnia and Depression in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118140
• Other study ID #: H19017
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: July 20, 2022

Study information

• Verified date: July 2022
• Source: Charles Darwin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using a robust research method following the MRC Framework, the proposed study will develop and test an evidence-based complementary health intervention to help breast cancer patients manage the fatigue-sleep disturbance-depression symptom cluster.

Description:

The fatigue-sleep disturbance-depression (FSD) symptom cluster is one of the most common symptom clusters in breast cancer (BC) patients, which can significantly deteriorate patients' functional status and quality of life. Since symptom cluster management has been unsatisfactory by using pharmacological treatments alone, the use of non-pharmacological adjuvant approaches has therefore been recommended. Being an important modality of acupoint stimulation, somatic acupressure (SA) can be a promising non-pharmacological intervention given its potential benefits for cancer symptom alleviation and its convenience for self-practice without increasing patients' physical and financial burden. However, current research on acupoint stimulation for cancer symptom management has been mainly focusing on individual symptom, and intervention protocols have been found significantly varied in intervention dosages and acupoint formula without a standardised protocol developed via a rigorous evidence-based research approach. The proposed study therefore 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 a better management of the FSD symptom cluster in BC. The first two phases of the MRC Framework will be included in this study. The first phase utilizes an evidence-based method to comprehensively review all available research evidence on acupoint-stimulation for cancer-related fatigue, sleep disturbance and depression, and further identify the most effective acupoint formula with the optimal SA duration and frequency. A preliminary SA protocol will then be developed based on the current research evidence and relevant theories and guidelines of acupoint stimulation. A content validity study will be conducted then to examine the content validity of the SA protocol via an expert panel. In the second phase, a feasibility randomized controlled trial (RCT) will be conducted to examine the acceptability of the SA protocol, pilot the methodological procedure of the clinical trial and preliminarily examine the effects of SA on the FSD symptom cluster in BC. Semi-structured interviews will be conducted afterwards to explore patients' experiences of participating in the study and receiving the SA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 20, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. BC stage I to IIIa;

2. have experienced at least a moderate level of the FSD symptom cluster, with a score of 4 or above on a 10-point numeric rating scale, from "0 (no symptom)" to "10 (worst symptom)", for each symptom during the past one month;

3. have completed adjuvant chemotherapy for at least one month and up to three years;

4. have not scheduled chemotherapy and radiotherapy during the whole study period;

5. willing to participate in the RCT and provide written informed consent.

Exclusion criteria:

1. presently taking pharmaceutical agents to treat fatigue, sleep disturbance or depression, such as antidepressant medications, psychostimulants, or hypnotics;

2. extremely weak and/or have cognitive impairment which make them unable (or difficult) to follow the study procedures and instructions;

3. having the experience of any types of SAS treatment during the past six months;

4. presently participating in any other research projects.

Related Conditions & MeSH terms

• Cancer
• Syndrome

Intervention

Other:
• Somatic Acupressure
7-week self-acupressure plus usual care (an education booklet)
• Sham acupressure
Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)
• Usual care
Usual care only (an education booklet)

Locations

Country	Name	City	State
China	The Affiliated Hospital Of Southwest Medical University	Luzhou	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Charles Darwin University	The Affiliated Hospital Of Southwest Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEASIBILITY: Eligibility rate	Eligibility rate as assessed by (the number of eligible participants / number of participants screened) x 100%	Immediately after completion of the intervention (T2)
Primary	FEASIBILITY: Recruitment rate	Recruitment rate as assessed by (the number of participants who participated in the study / number of eligible participants) x 100%	Immediately after completion of the intervention (T2)
Primary	FEASIBILITY: Retention rate	Retention rate as assessed by (the number of participants who completed the study / number of participants who enrolled in) x 100%	Immediately after completion of the intervention (T2)
Primary	FEASIBILITY: Attrition rate	Attrition rate as assessed by (the number of participants who dropped out after the randomization / number of participants who enrolled in) x 100%	Immediately after completion of the intervention (T2)
Primary	FEASIBILITY: subject recruitment	Feasibility of subject recruitment assessed by interviewing the participants' feedback regarding why they discontinued this study	Immediately after completion of the intervention (T2)
Primary	FEASIBILITY: Duration for completing the subject recruitment	Time period from the recruitment of first participants to the last patient: assessed by months	Immediately after completion of the intervention (T2)
Primary	ACCEPTABILITY: Actual days of acupressure	The number of days that the participants perform the SA interventions, where the scheduled sessions should be 7 weeks of daily acupressure	Immediately after completion of the intervention (T2)
Primary	ACCEPTABILITY: duration of each acupressure session	Duration of each time (minutes) of acupressure where the scheduled time per session should be around 36 minutes	Immediately after completion of the intervention (T2)
Primary	ACCEPTABILITY: SA protocol	Participants' feedback and satisfaction with the SA intervention assessed by a self-designed feedback form and follow-up semi-structured interviews	Immediately after completion of the intervention (T2)
Primary	FEASIBILITY: Questionnaire-Item-level missing value of each questionnaire	Item-level missing value of each questionnaire (%) assessed by the percentage of participants who do not answer any single item	Immediately after completion of the intervention (T2)
Primary	FEASIBILITY: Questionnaire-Scale-level missing value of the questionnaire	Scale-level missing value of the questionnaire (%) assessed by the percentage of participants who do not answer at least one item in the whole questionnaire	Immediately after completion of the intervention (T2)
Primary	SAFETY: adverse events	Number of adverse events occur during the intervention	Immediately once an adverse event occurs
Secondary	Fatigue	Fatigue measured by the Multidimensional Fatigue Inventory	Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
Secondary	Sleep disturbance	Insomnia measured by Pittsburgh Sleep Quality Index	Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
Secondary	Depression	Depression measured by Hospital Anxiety and Depression Scale	Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
Secondary	Patients' quality of Life	Measured by the Functional Assessment of Cancer Therapy-Breast Cancer	Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)