A Pilot Tele-rehabilitation Trial for Breast Cancer Survivors

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04269967
• Other study ID #: 2019/00283
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: National University, Singapore
• Contact: Miho Asano
• Phone: 6565166929
• Email: epham[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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°)

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• Receiving routine rehabilitation care via tele-rehabilitation system
Drain care education, self-massage techniques and exercise (PT and OT)

Locations

Country	Name	City	State
Singapore	Miho Asano	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
National University, Singapore	National Cancer Centre, Singapore, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Shoulder range of motion	Shoulder ranger of motion will be measured in degree.	Pre rehabilitation (week 0) and post-rehabilitation (week 12)
Primary	Arm circumference	Arm circumference will be measured in cm	Pre rehabilitation (week 0) and post-rehabilitation (week 12)