Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients

NCT04118140 | Completed DMC

• 1 other identifier: H19017
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; acupressure; fatigue; depression; insomnia; symptom cluster

Outcome Measures

Primary Outcomes (12)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• SAFETY: adverse events

  Number of adverse events occur during the intervention

  Immediately once an adverse event occurs

Secondary Outcomes (4)

• Fatigue

  Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)

• Sleep disturbance

  Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)

• Depression

  Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)

• Patients' quality of Life

  Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)

Study Arms (3)

True SA (Somatic Acupressure ) group

EXPERIMENTAL

Receiving true somatic acupressure+usual care

Other: Somatic Acupressure; Other: Usual care

Sham SA group

SHAM COMPARATOR

Receiving sham somatic acupressure+usual care

Other: Sham acupressure; Other: Usual care

Usual care group

OTHER

Receiving usual care only (an education booklet regarding knowledge of BC and FSD symptom cluster management advice)

Other: Usual care

Interventions

Somatic Acupressure OTHER

7-week self-acupressure plus usual care (an education booklet)

True SA (Somatic Acupressure ) group

Sham acupressure OTHER

Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)

Sham SA group

Usual care OTHER

Usual care only (an education booklet)

Sham SA group; True SA (Somatic Acupressure ) group; Usual care group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BC stage I to IIIa;
• 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;
• have completed adjuvant chemotherapy for at least one month and up to three years;
• have not scheduled chemotherapy and radiotherapy during the whole study period;
• willing to participate in the RCT and provide written informed consent.

You may not qualify if:

• presently taking pharmaceutical agents to treat fatigue, sleep disturbance or depression, such as antidepressant medications, psychostimulants, or hypnotics;
• extremely weak and/or have cognitive impairment which make them unable (or difficult) to follow the study procedures and instructions;
• having the experience of any types of SAS treatment during the past six months;
• presently participating in any other research projects.

Sponsors & Collaborators

• Charles Darwin University: lead
• The Affiliated Hospital Of Southwest Medical University: collaborator

Study Sites (1)

The Affiliated Hospital Of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Related Publications (1)

• Wang T, Tan JB, Liu XL, Zheng SL, Zhao I, Eliseeva S, Polotan MJ, Cheng HL, Huang HQ. Implementing an evidence-based somatic acupressure intervention in breast cancer survivors with the symptom cluster of fatigue, sleep disturbance and depression: study protocol of a phase II randomised controlled trial. BMJ Open. 2022 Jan 20;12(1):e054597. doi: 10.1136/bmjopen-2021-054597.

  PMID: 35058263 DERIVED

MeSH Terms

Conditions

Neoplasms; Fatigue; Depression; Sleep Initiation and Maintenance Disorders; Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Disease; Pathologic Processes

Study Officials

• Jing-Yu (Benjamin) Tan, PhD RN

  Charles Darwin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 8, 2019
• Study Start: March 15, 2021
• Primary Completion: May 17, 2022
• Study Completion: July 20, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

CN (1)