A Pilot Tele-rehabilitation Trial for Breast Cancer Survivors

Sponsor
National University, Singapore (Other)
Overall Status
Recruiting
CT.gov ID
NCT04269967
Collaborator
Singapore General Hospital (Other), National Cancer Centre, Singapore (Other)
40
1
26
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Receiving routine rehabilitation care via tele-rehabilitation system

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Pilot Feasibility Study of a Tele-rehabilitation System Among Women Who Undergo a Unilateral Mastectomy for Breast Cancer
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The experience of rehabilitation (i.e., drain care, exercise and massage) [12 weeks from the baseline assessment]

    We will interview our participants about their experience of going through a rehabilitation process. This is qualitative data.

  2. Shoulder range of motion [Pre rehabilitation (week 0) and post-rehabilitation (week 12)]

    Shoulder ranger of motion will be measured in degree.

  3. Arm circumference [Pre rehabilitation (week 0) and post-rehabilitation (week 12)]

    Arm circumference will be measured in cm

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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°)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Miho Asano Singapore Singapore 117549

Sponsors and Collaborators

  • National University, Singapore
  • Singapore General Hospital
  • National Cancer Centre, Singapore

Investigators

  • Principal Investigator: Miho Asano, SSHSPH NUS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Miho Asano, Assistant Professor, National University, Singapore
ClinicalTrials.gov Identifier:
NCT04269967
Other Study ID Numbers:
  • 2019/00283
First Posted:
Feb 17, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022