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Clinical Trials/NCT04269967
NCT04269967
Recruiting
Not Applicable

A Pilot Feasibility Study of a Tele-rehabilitation System Among Women Who Undergo a Unilateral Mastectomy for Breast Cancer

National University of Singapore1 site in 1 country40 target enrollmentNovember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
National University of Singapore
Enrollment
40
Locations
1
Primary Endpoint
Arm circumference
Status
Recruiting
Last Updated
3 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Miho Asano

Assistant Professor

National University of Singapore

Eligibility Criteria

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°)

Outcomes

Primary Outcomes

Arm circumference

Time Frame: Pre rehabilitation (week 0) and post-rehabilitation (week 12)

Arm circumference will be measured in cm

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.

Study Sites (1)

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