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Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance in Breast Cancer

Primary Purpose

Breast Neoplasms, Cancer Survivor

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ture self-acupressure
Sham self-acupressure
Usual care
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria

  • Female adult aged 18 and older;
  • Clinical diagnosis of early-stage (Stage I, II, or IIIa), hormone-receptor-positive breast cancer;
  • Completion of surgery, and/or chemotherapy and/or radiotherapy;
  • Currently taking the third generation of AIs (anastrozole, letrozole, or exemestane) for at least 1 month;
  • Based on their self-reports of moderate symptoms of joint pain and fatigue or sleep disturbance;
  • Willing to comply with the intervention protocol, and
  • Being able to communicate in Chinese .

Exclusion Criteria:

  • Previous receipt of acupuncture and acupressure within the past six months;
  • Currently receiving medications (unchanged for 3 month), physical therapy and other complementary and alternative medicines for the treatment of joint pain, fatigue and sleep disturbance;
  • Prior joint surgery or fracture during the past six months;
  • Mentally incapable of participating in the study (Hong Kong version of Montreal Cognitive Assessment score<22);and
  • Inability to perform self-care (Karnofsky Performance Scale score<70).

Sites / Locations

  • The Huazhong University of Science and Technology Union Shenzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

True self-acupressure

Sham self-acupressure

Usual care

Arm Description

1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks.

Same protocol to the true self-acupressure group but on the sham acupoints

General advise on managing symptoms provided by healthcare providers

Outcomes

Primary Outcome Measures

Feasibility measure
Eligibility rate
Feasibility measure
Recruitment rate
Feasibility measure
Attrition rate
Feasibility measure
Time to complete the recruitment
Feasibility measure
Intervention adherence (using a patient-reported diary to document if the patient has completed the intervention daily, experienced any side effects, any other feelings or thoughts )
Acceptability measure
Appropriateness of the intervention components using a self-developed questionnaire (15 close-ended questions mostly on a scale of 1 to 5, higher score indicating higher acceptability and 3 open-ended questions)

Secondary Outcome Measures

Arthralgia
The Brief Pain Inventory- Short Form to assess joint pain related to aromatase inhibitor-induced arthralgia on a scale of 0=no pain, 10=extreme pain
Fatigue
The Brief Fatigue Inventory to measure fatigue on a scale of 0=no fatigue, 10=extreme fatigue
Sleep disturbance
The Pittsburgh Sleep Quality Index (PSQI) to measure sleep disturbance (with different item options) [a global score ranges from 0 to 21, with a higher score indicating poor sleep quality]
Health-related quality of life
The Functional Assessment of Cancer Therapy scale (FACT-G) to measure health-related quality of life on a scale of 0=lower health-related quality of life, 4=higher health-related quality of life

Full Information

First Posted
March 29, 2021
Last Updated
August 30, 2021
Sponsor
The Hong Kong Polytechnic University
Collaborators
The Huazhong University of Science and Technology Union Shenzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04927910
Brief Title
Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance in Breast Cancer
Official Title
Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance Symptom Cluster in Breast Cancer Survivors Receiving Aromatase Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2021 (Actual)
Primary Completion Date
March 29, 2022 (Anticipated)
Study Completion Date
March 29, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
The Huazhong University of Science and Technology Union Shenzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to evaluate the feasibility, acceptability and preliminary effects of self-applied acupressure on arthralgia-fatigue-sleep disturbance symptom cluster in breast cancer survivors receiving aromatase inhibitors. This is a preliminary randomized controlled trial, with a three-arm trial design including verum self-acupressure, sham self-acupressure, and usual care. Subjects will include 52 breast cancer survivors who are receiving aromatase inhibitors and have experienced a moderate level of joint pain and at least one of the two symptoms including fatigue and sleep disturbance. Subjects who are randomized to either the verum self-acupressure group (group A) or the sham self-acupressure group (group B) will receive up to 8 weeks of the intervention consisting of two components: (1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks. The method and duration of self-acupressure in the sham group will be the same to those in the verum intervention group. The control group will receive usual care. The outcome measures of this study will be related to feasibility, acceptability and preliminary effects of self-acupressure. Individual in-depth interviews will be conducted with selected participants in group A and B to understand their perceptions and perceived effectiveness of the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Cancer Survivor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
True self-acupressure
Arm Type
Experimental
Arm Description
1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks.
Arm Title
Sham self-acupressure
Arm Type
Sham Comparator
Arm Description
Same protocol to the true self-acupressure group but on the sham acupoints
Arm Title
Usual care
Arm Type
Other
Arm Description
General advise on managing symptoms provided by healthcare providers
Intervention Type
Other
Intervention Name(s)
Ture self-acupressure
Intervention Description
8-week intervention of self-acupressure on acupoints
Intervention Type
Other
Intervention Name(s)
Sham self-acupressure
Intervention Description
8-week intervention of self-acupressure on non-acupoints
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
routine care by hospitals
Primary Outcome Measure Information:
Title
Feasibility measure
Description
Eligibility rate
Time Frame
Immediately after completion of the intervention (T1)
Title
Feasibility measure
Description
Recruitment rate
Time Frame
Immediately after completion of the intervention (T1)
Title
Feasibility measure
Description
Attrition rate
Time Frame
Immediately after completion of the intervention (T1)
Title
Feasibility measure
Description
Time to complete the recruitment
Time Frame
Immediately after completion of the intervention (T1)
Title
Feasibility measure
Description
Intervention adherence (using a patient-reported diary to document if the patient has completed the intervention daily, experienced any side effects, any other feelings or thoughts )
Time Frame
Immediately after completion of the intervention (T1)
Title
Acceptability measure
Description
Appropriateness of the intervention components using a self-developed questionnaire (15 close-ended questions mostly on a scale of 1 to 5, higher score indicating higher acceptability and 3 open-ended questions)
Time Frame
Immediately after completion of the intervention (T1)
Secondary Outcome Measure Information:
Title
Arthralgia
Description
The Brief Pain Inventory- Short Form to assess joint pain related to aromatase inhibitor-induced arthralgia on a scale of 0=no pain, 10=extreme pain
Time Frame
Baseline(T0) and Immediately after completion of the intervention (T1)
Title
Fatigue
Description
The Brief Fatigue Inventory to measure fatigue on a scale of 0=no fatigue, 10=extreme fatigue
Time Frame
Baseline(T0) and Immediately after completion of the intervention (T1)
Title
Sleep disturbance
Description
The Pittsburgh Sleep Quality Index (PSQI) to measure sleep disturbance (with different item options) [a global score ranges from 0 to 21, with a higher score indicating poor sleep quality]
Time Frame
Baseline(T0) and Immediately after completion of the intervention (T1)
Title
Health-related quality of life
Description
The Functional Assessment of Cancer Therapy scale (FACT-G) to measure health-related quality of life on a scale of 0=lower health-related quality of life, 4=higher health-related quality of life
Time Frame
Baseline(T0) and Immediately after completion of the intervention (T1)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Female adult aged 18 and older; Clinical diagnosis of early-stage (Stage I, II, or IIIa), hormone-receptor-positive breast cancer; Completion of surgery, and/or chemotherapy and/or radiotherapy; Currently taking the third generation of AIs (anastrozole, letrozole, or exemestane) for at least 1 month; Based on their self-reports of moderate symptoms of joint pain and fatigue or sleep disturbance; Willing to comply with the intervention protocol, and Being able to communicate in Chinese . Exclusion Criteria: Previous receipt of acupuncture and acupressure within the past six months; Currently receiving medications (unchanged for 3 month), physical therapy and other complementary and alternative medicines for the treatment of joint pain, fatigue and sleep disturbance; Prior joint surgery or fracture during the past six months; Mentally incapable of participating in the study (Hong Kong version of Montreal Cognitive Assessment score<22);and Inability to perform self-care (Karnofsky Performance Scale score<70).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huilin Cheng, PhD
Phone
(852) 2766 4771
Email
eileen.cheng@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huilin Cheng, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Huazhong University of Science and Technology Union Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenying Li, Master

12. IPD Sharing Statement

Plan to Share IPD
No

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Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance in Breast Cancer

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