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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
51
7-week self-acupressure plus usual care (an education booklet)
Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)
Usual care only (an education booklet)
The Affiliated Hospital Of Southwest Medical University
Luzhou, Sichuan, China
FEASIBILITY: Eligibility rate
Eligibility rate as assessed by (the number of eligible participants / number of participants screened) x 100%
Time frame: Immediately after completion of the intervention (T2)
FEASIBILITY: Recruitment rate
Recruitment rate as assessed by (the number of participants who participated in the study / number of eligible participants) x 100%
Time frame: Immediately after completion of the intervention (T2)
FEASIBILITY: Retention rate
Retention rate as assessed by (the number of participants who completed the study / number of participants who enrolled in) x 100%
Time frame: Immediately after completion of the intervention (T2)
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%
Time frame: Immediately after completion of the intervention (T2)
FEASIBILITY: subject recruitment
Feasibility of subject recruitment assessed by interviewing the participants' feedback regarding why they discontinued this study
Time frame: Immediately after completion of the intervention (T2)
FEASIBILITY: Duration for completing the subject recruitment
Time period from the recruitment of first participants to the last patient: assessed by months
Time frame: Immediately after completion of the intervention (T2)
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
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Time frame: Immediately after completion of the intervention (T2)
ACCEPTABILITY: duration of each acupressure session
Duration of each time (minutes) of acupressure where the scheduled time per session should be around 36 minutes
Time frame: Immediately after completion of the intervention (T2)
ACCEPTABILITY: SA protocol
Participants' feedback and satisfaction with the SA intervention assessed by a self-designed feedback form and follow-up semi-structured interviews
Time frame: Immediately after completion of the intervention (T2)
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
Time frame: Immediately after completion of the intervention (T2)
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
Time frame: Immediately after completion of the intervention (T2)
SAFETY: adverse events
Number of adverse events occur during the intervention
Time frame: Immediately once an adverse event occurs
Fatigue
Fatigue measured by the Multidimensional Fatigue Inventory
Time frame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
Sleep disturbance
Insomnia measured by Pittsburgh Sleep Quality Index
Time frame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
Depression
Depression measured by Hospital Anxiety and Depression Scale
Time frame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
Patients' quality of Life
Measured by the Functional Assessment of Cancer Therapy-Breast Cancer
Time frame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)