A Pilot Tele-rehabilitation Trial for Breast Cancer Survivors

NCT ID: NCT04269967

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Female

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Tele-rehabilitation

Patients who choose tele-rehabilitation

Receiving routine rehabilitation care via tele-rehabilitation system

Intervention Type OTHER

Drain care education, self-massage techniques and exercise (PT and OT)

Usual care

Patients who choose usual (rehabilitation) care

No interventions assigned to this group

Interventions

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Receiving routine rehabilitation care via tele-rehabilitation system

Drain care education, self-massage techniques and exercise (PT and OT)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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°)
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role collaborator

National Cancer Centre, Singapore

OTHER

Sponsor Role collaborator

National University of Singapore

OTHER

Sponsor Role lead

Responsible Party

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Miho Asano

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miho Asano

Role: PRINCIPAL_INVESTIGATOR

SSHSPH NUS

Locations

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Miho Asano

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Miho Asano

Role: CONTACT

6565166929

Facility Contacts

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Miho Asano, PhD

Role: primary

(65) 6516 6929

References

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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.

Reference Type DERIVED
PMID: 33522962 (View on PubMed)

Other Identifiers

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2019/00283

Identifier Type: -

Identifier Source: org_study_id

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