Breast Cancer FemaleNCT04269967
A Pilot Tele-rehabilitation Trial for Breast Cancer Survivors
An observational study of Breast Cancer Female, run by National University of Singapore at 1 site in Singapore.
Trial summary
Breast cancer is the leading cancer affecting women in Singapore. Breast cancer survivors commonly experience declined physical function and quality of life, due to their upper limb morbidity and wound issues post-surgery. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Receiving routine rehabilitation care via tele-rehabilitation system
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Nov 2020to 31 Dec 2022
- Phase
- Observational
- 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 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adults female who are undergoing or underwent a unilateral breast surgery (wide excision or simple mastectomy) with lymph nodes removed at two participating sites in Singapore.
Who may be able to join
- Female 21 years and over
- Underwent a recent unilateral breast surgery (wide excision or simple mastectomy) with lymph nodes removed
- Speak and write English or Mandarin;
- No psychiatric history or chronic psychiatric condition as assessed by referring clinician
Who cannot join
- Having breast reconstruction
- Having legal blindness or severe visual impairment
- Having life expectancy of less than three months (12- weeks)
- Having previous upper limb injury or conditions that limit passive ranges of shoulder flexion (<150°), elbow extension/flexion (0/145°)
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Miho Asano
Singapore, 117549
Miho Asano, PhD, (65) 6516 6929, epham@nus.edu.sg
About this study
Official title: A Pilot Feasibility Study of a Tele-rehabilitation System Among Women Who Undergo a Unilateral Mastectomy for Breast Cancer
Breast cancer is the leading cancer affecting women in Singapore. Breast cancer survivors commonly experience declined physical function and quality of life, due to their upper limb morbidity and wound issues post-surgery. Rehabilitation therapy can address the aforementioned issues that the survivors may experience during their recovery. No therapy however, can be effective if patients do not utilize them. Home-based telehealth (e.g., tele-rehabilitation) self-managed by patients and guided by healthcare professionals can potentially improve the service use and recovery. This study aims to understand the lived experience of post-mastectomy tele-rehabilitation and recovery process among female patients who undergo a unilateral mastectomy for breast cancer.
- Conditions
- Breast Cancer Female
- Being tested
- Receiving routine rehabilitation care via tele-rehabilitation system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiving routine rehabilitation care via tele-rehabilitation systemOther
Drain care education, self-massage techniques and exercise (PT and OT)
| Study group | Role | What they receive |
|---|---|---|
| Tele-rehabilitation | Patients who choose tele-rehabilitation Receives: Other: Receiving routine rehabilitation care via tele-rehabilitation system | |
| Usual care | Patients who choose usual (rehabilitation) care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The experience of rehabilitation (i.e., drain care, exercise and massage)
We will interview our participants about their experience of going through a rehabilitation process. This is qualitative data.
Measured: 12 weeks from the baseline assessment
Shoulder range of motion
Shoulder ranger of motion will be measured in degree.
Measured: Pre rehabilitation (week 0) and post-rehabilitation (week 12)
Arm circumference
Arm circumference will be measured in cm
Measured: Pre rehabilitation (week 0) and post-rehabilitation (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, National Cancer Centre, Singapore
- Responsible party
- Principal investigator, Miho Asano, National University of Singapore
- Investigators
- Miho Asano, Principal investigator, SSHSPH NUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269967
- Sponsor's protocol ID
- 2019/00283
- Other IDs
- 2019
- Status last verified
- Sep 2022
- First submitted
- 7 Feb 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asano M, Koh GC, Madhukumar P, Teng GYH, Liew PLL, Nagalingam S, Tan MLM, Ng YS, Tan BKT. Study protocol: a pilot quasi-experimental trial of tele-rehabilitation and tele-drain care post-mastectomy. Pilot Feasibility Stud. 2021 Feb 1;7(1):39. doi: 10.1186/s40814-021-00776-5.
PubMed 33522962
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of a Tele-rehabilitation System Among Women Who Undergo a Unilateral Mastectomy for Breast Cancer
- ClinicalTrials.gov ID
- NCT04269967
- Acronym / sponsor ID
- 2019/00283
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Singapore General Hospital, National Cancer Centre, Singapore
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Feb 2020 (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.
Breast cancer is the leading cancer affecting women in Singapore. Breast cancer survivors commonly experience declined physical function and quality of life, due to their upper limb morbidity and wound issues post-surgery. Rehabilitation therapy can address the aforementioned issues that the survivors may experience during their recovery. No therapy however, can be effective if patients do not utilize them. Home-based telehealth (e.g., tele-rehabilitation) self-managed by patients and guided by healthcare professionals can potentially improve the service use and recovery. This study aims to understand the lived experience of post-mastectomy tele-rehabilitation and recovery process among female patients who undergo a unilateral mastectomy for breast cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-rehabilitation | – | Other: Receiving routine rehabilitation care via tele-rehabilitation systemPatients who choose tele-rehabilitation |
| Usual care | – | –Patients who choose usual (rehabilitation) care |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults female who are undergoing or underwent a unilateral breast surgery (wide excision or simple mastectomy) with lymph nodes removed at two participating sites in Singapore.
Key inclusion criteria (4 listed)
- Female 21 years and over
- Underwent a recent unilateral breast surgery (wide excision or simple mastectomy) with lymph nodes removed
- Speak and write English or Mandarin;
- No psychiatric history or chronic psychiatric condition as assessed by referring clinician
Key exclusion criteria (4 listed)
- Having breast reconstruction
- Having legal blindness or severe visual impairment
- Having life expectancy of less than three months (12- weeks)
- Having previous upper limb injury or conditions that limit passive ranges of shoulder flexion (<150°), elbow extension/flexion (0/145°)
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 |
|---|---|---|
| Receiving routine rehabilitation care via tele-rehabilitation systemDrain care education, self-massage techniques and exercise (PT and OT) | Other | Tele-rehabilitation |
Primary outcome
The experience of rehabilitation (i.e., drain care, exercise and massage)
Time frame: 12 weeks from the baseline assessment
We will interview our participants about their experience of going through a rehabilitation process. This is qualitative data.
Shoulder range of motion
Time frame: Pre rehabilitation (week 0) and post-rehabilitation (week 12)
Shoulder ranger of motion will be measured in degree.
Arm circumference
Time frame: Pre rehabilitation (week 0) and post-rehabilitation (week 12)
Arm circumference will be measured in cm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Derived from this study: PubMed 33522962Asano M, Koh GC, Madhukumar P, Teng GYH, Liew PLL, Nagalingam S, Tan MLM, Ng YS, Tan BKT. Study protocol: a pilot quasi-experimental trial of tele-rehabilitation and tele-drain care post-mastectomy. Pilot Feasibility Stud. 2021 Feb 1;7(1):39. doi: 10.1186/s40814-021-00776-5.
- Individual participant dataSharing planned: No
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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.
Miho Asano principal investigator
SSHSPH NUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by National University of Singapore at 1 site in Singapore.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Sep 2022. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miho Asano (6565166929, epham@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The experience of rehabilitation (i.e., drain care, exercise and massage) (time frame: 12 weeks from the baseline assessment). The study lists 3 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 NCT04269967, 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 28 Sep 2022.