NCT06753357

Brief Summary

The investigators are attempting to verify the prevalence of cancer rehabilitation needs at our institution in breast cancer patients. The investigators also want to assess 1) self-perceived needs for cancer rehabilitation services, 2) awareness, willingness, and patient health beliefs as determinants for cancer rehabilitation-seeking behaviour, and 3) the modifiable patient factors driving the mismatch between needs and uptake in our population. Patients attending outpatient clinics in our hospital will be approached to answer a questionnaire designed to find out this information. The investigators hope that the results will ultimately inform the design of better triage and referral systems that match patients to services based on their rehabilitation needs. The investigators believe that local survivors of breast cancer have unmet rehabilitation needs and that it is possible to evaluate their readiness to seek access to rehabilitation services as well as identify mismatches between provided and desired services through the administration of a cancer rehabilitation questionnaire (CRQ).

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
376

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

December 17, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

December 17, 2024

Last Update Submit

December 22, 2024

Conditions

Keywords

Breast cancerCancer rehabilitationRehabilitation needsRehabilitation service uptakeCancer survivorshipHealth Belief ModelTechnological enablers

Outcome Measures

Primary Outcomes (1)

  • Symptom/impairment prevalence

    The prevalence of reported symptoms and impairments among breast cancer survivors.

    At the point of recruitment

Secondary Outcomes (4)

  • Awareness of available support

    At the point of recruitment

  • Willingness to receive support

    At the point of recruitment

  • Health beliefs in relation to receiving rehabilitation support

    At the point of recruitment

  • Agreement on level of care

    At the point of recruitment

Study Arms (1)

Eligible patients

Female patients from the Breast Surgery clinic at Changi General Hospital (with referrals from the on-site Medical Oncology clinic). A consecutive purposive sample of 400 participants will be recruited. There are no race-based or minority-based subject restrictions. Male patients with breast cancer are rare and are thus excluded from recruitment. Patients will be approached by a clinical research co-ordinator (CRC) or study team member who will explain the study and seek consent for recruitment.

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive purposive sample of all female patients with breast cancer in the Breast Surgery and Medical Oncology clinics.

You may qualify if:

  • Female patients
  • Age 21yrs old and above
  • Histological diagnosis of breast cancer at any stage (or clinical consensus at a Tumour Board meeting, for example if the condition is metastatic and biopsy is not indicated for any reason)
  • Started treatment (surgical, medical, radiotherapeutic, or otherwise) with curative or palliative intent
  • Speak English, Mandarin, or Malay, or Tamil, and are able to understand a verbally-translated version of the questionnaire
  • Able to provide informed consent

You may not qualify if:

  • Unable to answer the questionnaire for any reasons such as cognitive impairment or sensory dysfunction
  • Declined participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 554341, Singapore

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Edmund JR Neo, MBBS MRCP

    Singapore Health Services Pte Ltd

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 31, 2024

Study Start

January 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Data is protected under the SingHealth Data Protection Policy which is compliant to the Singapore Personal Data Protection Act 2012

Locations