Chronic PainNCT05257876

Breathing Exercise for Chronic Pain Management in Breast Cancer Survivors

A study testing Breathing exercise in people with Chronic Pain and Breast Neoplasms, run by Charles Darwin University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Chronic Pain, Breast Neoplasms, Cancer Survivors
What is being tested?: Breathing exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteChina
Study dates: 1 Jan 2023to 12 Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

The Affiliated Hospital Of Southwest Medical University
Luzhou, Sichuan, 646000

Other trials in China

About this study

Official title: An Evidence-based Breathing Exercise Intervention Protocol for Chronic Pain Management in Breast Cancer Survivors: A Preliminary Randomized Controlled Trial

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.

Read the 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.

Conditions: Chronic Pain, Breast Neoplasms, Cancer Survivors
Being tested: Breathing exercise
Keywords: Pain Management, Chronic Pain, Breast Neoplasms, Cancer survivors, Breathing Exercises
Medical subject headings: Chronic Pain, Breast Neoplasms, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Breathing exerciseOther
Participants will receive breathing exercise training, and a 4-week self exercise

Study groups in NCT05257876
Study group	Role	What they receive
Intervention group	Experimental	Participants in the intervention group will receive breathing exercise training, pain information booklet, and usual care. Receives: Other: Breathing exercise
Control group	No intervention	Participants in the control group will receive pain information booklet and usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility: Time taken to recruit planned sample
The time that was taken to recruit the planned sample size of participants
Measured: Immediately after the allocation of the last subject
Feasibility: Referral rate
The number of referrals made by clinicians in different departments divided by all referrals
Measured: Immediately after the referral of the last subject
Feasibility: Recruitment rate
Proportion of subjects who participated in the study from all subjects eligible for participation
Measured: Immediately after the recruitment of the last subject
Feasibility: Retention rate
Proportion of participants who completed the whole study divided by all subjects who enrolled in the study
Measured: At the follow-up assessment 4 weeks after the intervention completion (T3)
Feasibility: Dropout rate
The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study
Measured: At the follow-up assessment 4 weeks after the intervention completion (T3)
Reasons for dropping out
Feedback from the dropout subjects to identify their reasons for dropping out
Measured: Immediately once a dropout occurs
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)
Measured: 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)
Feasibility: Adherence rates
the percentage of BE sessions performed by participants divided by the total number of BE sessions required
Measured: Immediately after completion of the 4-week intervention (T2)
Participants' feedback
Participants' feedback on and satisfaction with the intervention using a specifically designed feedback form
Measured: Immediately after completion of the 4-week intervention (T2)
Adverse events associated with the intervention
Data will be collected from the participants' BE logbooks and supplemented by information collected during weekly telephone contact
Measured: Immediately once an adverse event occurs

Secondary outcomes (4)

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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202312 Aug 2023

First posted25 Feb 2022
Study start1 Jan 2023
Primary completion12 Aug 2023
Study completion12 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Open-labelled parallel pilot RCT
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05257876
Sponsor's protocol ID: H21089
Status last verified: Feb 2024
First submitted: 3 Feb 2022
Last updated: 16 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: It needs to get the participants' consent if the data is shared with other researchers.

Publications

Wang H, Tan JB, Wang T, Liu XL, Bressington D, Zheng SL, Huang HQ. Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial. BMJ Open. 2022 Dec 14;12(12):e064358. doi: 10.1136/bmjopen-2022-064358.
PubMed 36517097

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evidence-based Breathing Exercise Intervention Protocol for Chronic Pain Management in Breast Cancer Survivors: A Preliminary Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05257876
Acronym / sponsor ID: H21089
Conditions: Chronic Pain, Breast Neoplasms, Cancer Survivors
Keywords: Pain Management, Chronic Pain, Breast Neoplasms, Cancer survivors, Breathing Exercises
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Charles Darwin UniversityUniversity, hospital or other
Collaborators: The Affiliated Hospital Of Southwest Medical University
Study start: 1 Jan 2023 (actual)
Primary completion: 12 Aug 2023 (actual)
Study completion: 12 Aug 2023 (actual)
First posted: 25 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Open-labelled parallel pilot RCT

Arm	Type	Receives
Intervention group	Experimental	Other: Breathing exerciseParticipants in the intervention group will receive breathing exercise training, pain information booklet, and usual care.
Control group	No intervention	–Participants in the control group will receive pain information booklet and usual care.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Breathing exerciseParticipants will receive breathing exercise training, and a 4-week self exercise	Other	Intervention group

Primary outcome

Feasibility: Time taken to recruit planned sample
Time frame: Immediately after the allocation of the last subject
The time that was taken to recruit the planned sample size of participants
Feasibility: Referral rate
Time frame: Immediately after the referral of the last subject
The number of referrals made by clinicians in different departments divided by all referrals
Feasibility: Recruitment rate
Time frame: Immediately after the recruitment of the last subject
Proportion of subjects who participated in the study from all subjects eligible for participation
Feasibility: Retention rate
Time frame: At the follow-up assessment 4 weeks after the intervention completion (T3)
Proportion of participants who completed the whole study divided by all subjects who enrolled in the study
Feasibility: Dropout rate
Time frame: At the follow-up assessment 4 weeks after the intervention completion (T3)
The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study
Reasons for dropping out
Time frame: Immediately once a dropout occurs
Feedback from the dropout subjects to identify their reasons for dropping out
Feasibility of the questionnaires
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)
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
Time frame: Immediately after completion of the 4-week intervention (T2)
the percentage of BE sessions performed by participants divided by the total number of BE sessions required
Participants' feedback
Time frame: Immediately after completion of the 4-week intervention (T2)
Participants' feedback on and satisfaction with the intervention using a specifically designed feedback form
Adverse events associated with the intervention
Time frame: Immediately once an adverse event occurs
Data will be collected from the participants' BE logbooks and supplemented by information collected during weekly telephone contact

4 secondary outcomes

Chronic 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)
Quality of life of breast cancer survivors ( using tool 1)
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)
Quality of Life of breast cancer survivors ( using tool 2)
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)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
Derived from this study: PubMed 36517097Wang H, Tan JB, Wang T, Liu XL, Bressington D, Zheng SL, Huang HQ. Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial. BMJ Open. 2022 Dec 14;12(12):e064358. doi: 10.1136/bmjopen-2022-064358.
Individual participant dataSharing planned: No. It needs to get the participants' consent if the data is shared with other researchers.

Related trials for Chronic Pain

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RecruitingObservational study
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Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Professor Jing-Yu (Benjamin) Tan, PhD principal investigator

Charles Darwin University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Breathing exercise in people with Chronic Pain and Breast Neoplasms, run by Charles Darwin University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Time taken to recruit planned sample (time frame: Immediately after the allocation of the last subject). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05257876, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.