Back to resultsBreathing Exercise for Chronic Pain Management in Breast Cancer Survivors
Primary Purpose
Chronic Pain, Breast Neoplasms, Cancer Survivors
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Breathing exercise
Sponsored by
About this trial
This is an interventional other trial for Chronic Pain focused on measuring Pain Management, Chronic Pain, Breast Neoplasms, Cancer survivors, Breathing Exercises
Eligibility Criteria
Inclusion Criteria:
- female breast cancer survivors ≥18 years age;
- has a confirmed diagnosis of breast cancer at stage I, II or IIIa;
- has been experiencing pain since cancer diagnosis constantly or intermittently for ≥3 months, with the average pain intensity in the last seven days on a numerical scale ≥4/10 ("0" indicates no pain and "10" indicates the worst pain);
- has completed active anticancer treatment (such as chemotherapy, radiotherapy, surgery) for at least three months;
- agrees to participate in the research and is willing to give informed consent;
- can read and understand Mandarin Chinese.
Exclusion Criteria:
- extremely weak and unable to perform the breathing exercises;
- mentally incapable (i.e., unable to follow the study instructions);
- has scheduled pain management interventions, such as having a procedure or operation;
- receiving other pain relief treatments, such as acupuncture, yoga, qigong, exercise program, etc.;
- has any pre-existing chronic pain conditions before cancer diagnosis, such as arthritis, rheumatoid arthritis, chronic low back pain, migraines, trigeminal neuralgia, fibromyalgia, joint dysfunction, Complex Regional Pain Syndrome, endometriosis, etc.
Sites / Locations
- The Affiliated Hospital Of Southwest Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Participants in the intervention group will receive breathing exercise training, pain information booklet, and usual care.
Participants in the control group will receive pain information booklet and usual care.
Outcomes
Primary Outcome Measures
Feasibility: Time taken to recruit planned sample
The time that was taken to recruit the planned sample size of participants
Feasibility: Referral rate
The number of referrals made by clinicians in different departments divided by all referrals
Feasibility: Recruitment rate
Proportion of subjects who participated in the study from all subjects eligible for participation
Feasibility: Retention rate
Proportion of participants who completed the whole study divided by all subjects who enrolled in the study
Feasibility: Dropout rate
The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study
Reasons for dropping out
Feedback from the dropout subjects to identify their reasons for dropping out
Feasibility of the questionnaires
The percentage of missing values for each item of the scales used, including the Brief Pain Inventory (BPI), Quality of life Cancer Survivors Version (QOL-CSV), Functional Assessment Cancer Therapy-Breast (FACT-B), and Hospital Anxiety and Depression Scale (HADS)
Feasibility: Adherence rates
the percentage of BE sessions performed by participants divided by the total number of BE sessions required
Participants' feedback
Participants' feedback on and satisfaction with the intervention using a specifically designed feedback form
Adverse events associated with the intervention
Data will be collected from the participants' BE logbooks and supplemented by information collected during weekly telephone contact
Secondary Outcome Measures
Chronic pain
Chronic pain will be measured by using the Brief Pain Inventory which measures pain intensity and pain interference with the life. For pain severity, four items are used to measure the "worst", "least", "average" and "now" with a rating scale from 0 to 10, higher number indicating the higher score in each item. For pain interference, pain is measured from 7 aspects of general activity, mood, walking, work, relations with others, sleep and enjoyment of life with a scale of 0-10, and higher score indicates severe impact of pain.
Quality of life of breast cancer survivors ( using tool 1)
Quality of life will be measured by using the Quality of Life Cancer Survivors Version. This questionnaire contains 41 items measuring quality of life of cancer survivors from four aspects including physical well-being, psychological well-being, social well-being and spiritual well-being. The score of each item is based on a scale of 0 ( worse outcome) to 10 ( best outcome). Higher score indicates better quality of life.
Quality of Life of breast cancer survivors ( using tool 2)
Quality of life will also be measured by using the Functional Assessment of Cancer Therapy-Breast. This questionnaire has 37 items with a 5-point Likert scale ranging from 0 to 4, a higher score indicating better QoL.
Anxiety and Depression
Anxiety and depression will be measured by using the Hospital Anxiety and Depression Scale (HADS). This scale contains 14 items consisting of two subscales: the anxiety subscale and depression subscale with 7 items in each. The scale uses a 4-point Likert scale ranging from 0 to 3, and higher score indicates severe anxiety and depression.
Full Information
NCT ID
NCT05257876
First Posted
February 3, 2022
Last Updated
September 1, 2022
Sponsor
Charles Darwin University
Collaborators
The Affiliated Hospital Of Southwest Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05257876
Brief Title
Breathing Exercise for Chronic Pain Management in Breast Cancer Survivors
Official Title
An Evidence-based Breathing Exercise Intervention Protocol for Chronic Pain Management in Breast Cancer Survivors: A Preliminary Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charles Darwin University
Collaborators
The Affiliated Hospital Of Southwest Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study will follow the MRC Framework to develop an evidence-based BE intervention protocol to help breast cancer survivors with better management of cancer-related chronic pain.
Detailed Description
Cancer-related chronic pain remains as a big challenge for cancer survivors, which significantly affects the quality of life of cancer survivors. Evidence suggests that pain is well managed through combination of pharmacological and non-pharmacological interventions. Among all non-pharmacological interventions, breathing exercise (BE) might have potential effect for chronic pain management in cancer survivors, but the evidence is sparse in current literature. Therefore, this study will follow the Medical Research Council Framework for Developing and Evaluating Complex intervention (the MRC Framework) to develop an evidence-based BE protocol to help with cancer-related chronic pain management in breast cancer survivors. The first two phases of the MRC Framework will be included in this study. In the first phase, an evidence-based method will be utilized to develop the BE intervention protocol. In the second phase, a pilot randomised controlled trial (RCT) will be conducted to examine the feasibility of study and the acceptability of the BE intervention by the participants as well as to preliminarily assess the effect of the BE on chronic pain management in breast cancer survivors. Semi-structured interviews will be conducted after the RCT to explore participants' experiences of participating in the study and practicing the BE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Breast Neoplasms, Cancer Survivors
Keywords
Pain Management, Chronic Pain, Breast Neoplasms, Cancer survivors, Breathing Exercises
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive breathing exercise training, pain information booklet, and usual care.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will receive pain information booklet and usual care.
Intervention Type
Other
Intervention Name(s)
Breathing exercise
Intervention Description
Participants will receive breathing exercise training, and a 4-week self exercise
Primary Outcome Measure Information:
Title
Feasibility: Time taken to recruit planned sample
Description
The time that was taken to recruit the planned sample size of participants
Time Frame
Immediately after the allocation of the last subject
Title
Feasibility: Referral rate
Description
The number of referrals made by clinicians in different departments divided by all referrals
Time Frame
Immediately after the referral of the last subject
Title
Feasibility: Recruitment rate
Description
Proportion of subjects who participated in the study from all subjects eligible for participation
Time Frame
Immediately after the recruitment of the last subject
Title
Feasibility: Retention rate
Description
Proportion of participants who completed the whole study divided by all subjects who enrolled in the study
Time Frame
At the follow-up assessment 4 weeks after the intervention completion (T3)
Title
Feasibility: Dropout rate
Description
The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study
Time Frame
At the follow-up assessment 4 weeks after the intervention completion (T3)
Title
Reasons for dropping out
Description
Feedback from the dropout subjects to identify their reasons for dropping out
Time Frame
Immediately once a dropout occurs
Title
Feasibility of the questionnaires
Description
The percentage of missing values for each item of the scales used, including the Brief Pain Inventory (BPI), Quality of life Cancer Survivors Version (QOL-CSV), Functional Assessment Cancer Therapy-Breast (FACT-B), and Hospital Anxiety and Depression Scale (HADS)
Time Frame
At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3)
Title
Feasibility: Adherence rates
Description
the percentage of BE sessions performed by participants divided by the total number of BE sessions required
Time Frame
Immediately after completion of the 4-week intervention (T2)
Title
Participants' feedback
Description
Participants' feedback on and satisfaction with the intervention using a specifically designed feedback form
Time Frame
Immediately after completion of the 4-week intervention (T2)
Title
Adverse events associated with the intervention
Description
Data will be collected from the participants' BE logbooks and supplemented by information collected during weekly telephone contact
Time Frame
Immediately once an adverse event occurs
Secondary Outcome Measure Information:
Title
Chronic pain
Description
Chronic pain will be measured by using the Brief Pain Inventory which measures pain intensity and pain interference with the life. For pain severity, four items are used to measure the "worst", "least", "average" and "now" with a rating scale from 0 to 10, higher number indicating the higher score in each item. For pain interference, pain is measured from 7 aspects of general activity, mood, walking, work, relations with others, sleep and enjoyment of life with a scale of 0-10, and higher score indicates severe impact of pain.
Time Frame
At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3)
Title
Quality of life of breast cancer survivors ( using tool 1)
Description
Quality of life will be measured by using the Quality of Life Cancer Survivors Version. This questionnaire contains 41 items measuring quality of life of cancer survivors from four aspects including physical well-being, psychological well-being, social well-being and spiritual well-being. The score of each item is based on a scale of 0 ( worse outcome) to 10 ( best outcome). Higher score indicates better quality of life.
Time Frame
At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3)
Title
Quality of Life of breast cancer survivors ( using tool 2)
Description
Quality of life will also be measured by using the Functional Assessment of Cancer Therapy-Breast. This questionnaire has 37 items with a 5-point Likert scale ranging from 0 to 4, a higher score indicating better QoL.
Time Frame
At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3)
Title
Anxiety and Depression
Description
Anxiety and depression will be measured by using the Hospital Anxiety and Depression Scale (HADS). This scale contains 14 items consisting of two subscales: the anxiety subscale and depression subscale with 7 items in each. The scale uses a 4-point Likert scale ranging from 0 to 3, and higher score indicates severe anxiety and depression.
Time Frame
At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gender eligibility is based on the physical appearance.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
female breast cancer survivors ≥18 years age;
has a confirmed diagnosis of breast cancer at stage I, II or IIIa;
has been experiencing pain since cancer diagnosis constantly or intermittently for ≥3 months, with the average pain intensity in the last seven days on a numerical scale ≥4/10 ("0" indicates no pain and "10" indicates the worst pain);
has completed active anticancer treatment (such as chemotherapy, radiotherapy, surgery) for at least three months;
agrees to participate in the research and is willing to give informed consent;
can read and understand Mandarin Chinese.
Exclusion Criteria:
extremely weak and unable to perform the breathing exercises;
mentally incapable (i.e., unable to follow the study instructions);
has scheduled pain management interventions, such as having a procedure or operation;
receiving other pain relief treatments, such as acupuncture, yoga, qigong, exercise program, etc.;
has any pre-existing chronic pain conditions before cancer diagnosis, such as arthritis, rheumatoid arthritis, chronic low back pain, migraines, trigeminal neuralgia, fibromyalgia, joint dysfunction, Complex Regional Pain Syndrome, endometriosis, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiying Wang, PhDc
Phone
+61 7 3169 4269
Email
haiying.wang@students.cdu.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Professor Jing-Yu (Benjamin) Tan, PhD
Phone
+61 7 3169 4269
Email
benjamin.tan@cdu.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Jing-Yu (Benjamin) Tan, PhD
Organizational Affiliation
Charles Darwin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital Of Southwest Medical University
City
Luzhou
State/Province
Sichuan
ZIP/Postal Code
646000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hou-Qiang Huang, MSc
Phone
001186-0830-3165290
Email
878620130@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It needs to get the participants' consent if the data is shared with other researchers.
Learn more about this trial
Breathing Exercise for Chronic Pain Management in Breast Cancer Survivors
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