A Pilot Tele-rehabilitation Trial for Breast Cancer Survivors

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: Breast Cancer Female
• Intervention / Treatment: Other: Receiving routine rehabilitation care via tele-rehabilitation system

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Miho Asano; Phone Number: 6565166929; Email: epham@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 117549
    • Recruiting
    • Miho Asano
    • Contact: Miho Asano, PhD; Phone Number: (65) 6516 6929; Email: epham@nus.edu.sg

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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)	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	Shoulder ranger of motion will be measured in degree.	Pre rehabilitation (week 0) and post-rehabilitation (week 12)
Arm circumference	Arm circumference will be measured in cm	Pre rehabilitation (week 0) and post-rehabilitation (week 12)

Collaborators and Investigators

• Sponsor: National University, Singapore
• Collaborators: Singapore General Hospital; National Cancer Centre, Singapore
• Investigators: Principal Investigator: Miho Asano, SSHSPH NUS

Publications and helpful links

General 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.

Study record dates

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: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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