A Pilot Tele-rehabilitation Trial for Breast Cancer Survivors

September 26, 2022 updated by: Miho Asano, National University, Singapore

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 117549
        • Recruiting
        • Miho Asano
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

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°)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tele-rehabilitation
Patients who choose tele-rehabilitation
Other: Receiving routine rehabilitation care via tele-rehabilitation system
Drain care education, self-massage techniques and exercise (PT and OT)
Usual care
Patients who choose usual (rehabilitation) care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks from the baseline assessment
Shoulder range of motion
Time Frame: Pre rehabilitation (week 0) and post-rehabilitation (week 12)
Shoulder ranger of motion will be measured in degree.
Pre rehabilitation (week 0) and post-rehabilitation (week 12)
Arm circumference
Time Frame: Pre rehabilitation (week 0) and post-rehabilitation (week 12)
Arm circumference will be measured in cm
Pre rehabilitation (week 0) and post-rehabilitation (week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University, Singapore

Collaborators

Singapore General Hospital
National Cancer Centre, Singapore

Investigators

  • Principal Investigator: Miho Asano, SSHSPH NUS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (ACTUAL)

February 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/00283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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