Cancer
Conditions
Keywords
Cancer, acupressure, fatigue, depression, insomnia, symptom cluster
Brief 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.
Detailed 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.
Interventions
OTHERSomatic Acupressure
7-week self-acupressure plus usual care (an education booklet)
OTHERSham acupressure
Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)
OTHERUsual care
Usual care only (an education booklet)
Sponsors
The Affiliated Hospital Of Southwest Medical University
Charles Darwin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This study can perform a partial blind design for participants in the true and sham intervention groups. Blind of outcome assessment will be also achieved in the true and sham intervention groups as all the questionnaires are patient-reported and the participants themselves will be the outcome assessors. Data analysis will be conducted by an independent statistician who are blinded to the group allocation.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SAFETY: adverse events | Immediately once an adverse event occurs | Number of adverse events occur during the intervention |
| ACCEPTABILITY: duration of each acupressure session | Immediately after completion of the intervention (T2) | Duration of each time (minutes) of acupressure where the scheduled time per session should be around 36 minutes |
| ACCEPTABILITY: SA protocol | Immediately after completion of the intervention (T2) | Participants' feedback and satisfaction with the SA intervention assessed by a self-designed feedback form and follow-up semi-structured interviews |
| FEASIBILITY: Questionnaire-Item-level missing value of each questionnaire | Immediately after completion of the intervention (T2) | Item-level missing value of each questionnaire (%) assessed by the percentage of participants who do not answer any single item |
| FEASIBILITY: Questionnaire-Scale-level missing value of the questionnaire | Immediately after completion of the intervention (T2) | 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 |
| FEASIBILITY: Eligibility rate | Immediately after completion of the intervention (T2) | Eligibility rate as assessed by (the number of eligible participants / number of participants screened) x 100% |
| FEASIBILITY: Recruitment rate | Immediately after completion of the intervention (T2) | Recruitment rate as assessed by (the number of participants who participated in the study / number of eligible participants) x 100% |
| FEASIBILITY: Retention rate | Immediately after completion of the intervention (T2) | Retention rate as assessed by (the number of participants who completed the study / number of participants who enrolled in) x 100% |
| FEASIBILITY: Attrition rate | Immediately after completion of the intervention (T2) | Attrition rate as assessed by (the number of participants who dropped out after the randomization / number of participants who enrolled in) x 100% |
| FEASIBILITY: subject recruitment | Immediately after completion of the intervention (T2) | Feasibility of subject recruitment assessed by interviewing the participants' feedback regarding why they discontinued this study |
| FEASIBILITY: Duration for completing the subject recruitment | Immediately after completion of the intervention (T2) | Time period from the recruitment of first participants to the last patient: assessed by months |
| ACCEPTABILITY: Actual days of acupressure | Immediately after completion of the intervention (T2) | The number of days that the participants perform the SA interventions, where the scheduled sessions should be 7 weeks of daily acupressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep disturbance | Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2) | Insomnia measured by Pittsburgh Sleep Quality Index |
| Depression | Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2) | Depression measured by Hospital Anxiety and Depression Scale |
| Patients' quality of Life | Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2) | Measured by the Functional Assessment of Cancer Therapy-Breast Cancer |
| Fatigue | Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2) | Fatigue measured by the Multidimensional Fatigue Inventory |
Countries
China
Outcome results
None listed