NCT04269967

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

2.2 years

First QC Date

February 7, 2020

Last Update Submit

September 26, 2022

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (3)

  • 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)

Study Arms (2)

Tele-rehabilitation

Patients who choose tele-rehabilitation

Other: Receiving routine rehabilitation care via tele-rehabilitation system

Usual care

Patients who choose usual (rehabilitation) care

Interventions

Receiving routine rehabilitation care via tele-rehabilitation systemOTHER

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

Tele-rehabilitation

Eligibility Criteria

Age21 Years - 99 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales identified by their healthcare providers.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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°)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miho Asano

Singapore, 117549, Singapore

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33522962DERIVED

Study Officials

  • Miho Asano

    SSHSPH NUS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miho Asano

CONTACT

6565166929epham@nus.edu.sg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 17, 2020

Study Start

November 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)