Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000045617
Ethics application status
Approved
Date submitted
8/01/2014
Date registered
17/01/2014
Date last updated
14/02/2022
Date data sharing statement initially provided
18/03/2019
Date results provided
18/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Choice of breast reconstruction (immediate, delayed or none) and quality of life for women undergoing mastectomy and radiotherapy for breast cancer.
Scientific title
A prospective observational study of women with breast cancer who have had mastectomy and post-mastectomy radiotherapy (PMRT), and quality of life outcomes according to their choice of breast reconstruction options (immediate, delayed or none).
Secondary ID [1] 283871 0
Nil
Universal Trial Number (UTN)
U1111-1151-1740
Trial acronym
QoLID (Quality of Life for Immediate, Delayed or declined breast reconstruction)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 290855 0
Condition category
Condition code
Cancer 291216 291216 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Quality of life, pain and aesthetic assessments (as measured by validated, standardised questionnaires over a five year period) in women following mastectomy and post-mastectomy radiotherapy, according to their choice of breast reconstruction options (immediate, delayed or none).
Intervention code [1] 288546 0
Not applicable
Comparator / control treatment
Not applicable - Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291210 0
To assess the quality of life of patients undergoing immediate, delayed or no reconstruction. The following validated tools are used in this assessment:
EORTC QLQ - C30
EORTC QLQ - BR23
Breast Q (mastectomy and reconstruction models, pre and post-op)
Body Image after Breast Cancer
Brief Pain Inventory
Pain Catastrophizing Scale
Timepoint [1] 291210 0
Baseline and at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-mastectomy.
Secondary outcome [1] 306241 0
1. Rate of acceptability of breast reconstruction. This is assessed by the woman's choice. We have also created a form that asks them to select reasons for their choice. This form includes a free answer section where they can add reasons not listed on the form.
Timepoint [1] 306241 0
Prior to mastectomy.
Secondary outcome [2] 306356 0
2. Patient assessment of aesthetic outcomes using a combination of the following surveys: EORTC QLQ 30, EORTC QLQ BR23, Breast Q and Body Image After Breast Cancer.
Timepoint [2] 306356 0
At baseline, 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-mastectomy.
Secondary outcome [3] 306357 0
3. Surgeon assessment of aesthetic outcomes, using pre-op and post-op forms created by the research team. The surgeons' ratings are compared with those of a blinded breast surgeon.
Timepoint [3] 306357 0
At baseline and 6 months post final reconstruction.
Secondary outcome [4] 306358 0
4. Rate of surgical and PMRT complications.
Timepoint [4] 306358 0
Information on complications recorded from patient records throughout the trial.
Secondary outcome [5] 306359 0
5. Significance of pain as experienced by patients, using Brief Pain Inventory and the Pain Catastrophizing Scale
Timepoint [5] 306359 0
At baseline (pre-op), and at 1, 3, 12, 18, 24, 36, 48 and 60 months post-mastectomy.
Secondary outcome [6] 306362 0
6. Overall rate (and cause-specific rates) of delay in delivery of adjuvant treatments.

Timepoint [6] 306362 0
Data recorded from patient records throughout the trial.
Secondary outcome [7] 306365 0
7. Long term outcomes up to five years (locoregional recurrence, disease free survival and overall survival).
Timepoint [7] 306365 0
Data recorded from patient records throughout the trial.

Eligibility
Key inclusion criteria
1. Diagnosed with breast cancer requiring mastectomy and likelihood of requiring PMRT.
2. Neo-adjuvant chemotherapy treated patients who are having mastectomy and planned for PMRT.
3. Able and willing to complete study questionnaires
4. Able to provide written & informed consent to participate in study.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prophylactic or risk-reducing surgery
2. Previous radiotherapy to the breast or chest precluding standard radiotherapy
3. Planned radiotherapy dose of <50Gy
4. Loco-regional recurrence precluding further radiotherapy
5. Previous wide local excision requiring completion mastectomy without the need for PMRT
6. Pregnant women
7. Distant metastatic disease
8. Inflammatory breast cancer

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is a pilot study which may be expanded depending on preliminary results. A minimum of 20 IBR patients and 20 delayed DBR patients would yield a point estimate for the difference between groups on a given continuous outcome parameter with a 95% confidence interval that extends no more than +/- 0.7 of a standard deviation (with 80% probability). This level of precision is considered sufficient to yield adequate estimates of the plausible effect size to inform the design of any subsequent expanded trial.

The aim is to recruit 40 immediate breast reconstruction patients, 30 delayed and as many non-reconstruction patients as possible.

Multi-level modelling in SAS v9.3 will be used to compare the three arms (immediate reconstruction, delayed reconstruction, no reconstruction) of the trial longitudinally over the 9 assessment points. This analysis will be conducted using both the primary and secondary outcomes as dependent variables listed above.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2013
Actual
5/07/2013
Date of last participant enrolment
Anticipated
24/12/2016
Actual
4/05/2016
Date of last data collection
Anticipated
31/07/2021
Actual
26/07/2021
Sample size
Target
80
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1940 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 7683 0
2060 - North Sydney
Recruitment outside Australia
Country [1] 6890 0
New Zealand
State/province [1] 6890 0
Waikato

Funding & Sponsors
Funding source category [1] 288517 0
Charities/Societies/Foundations
Name [1] 288517 0
Friends of the Mater Foundation
Country [1] 288517 0
Australia
Primary sponsor type
Other
Name
Breast & Surgical Oncology at The Poche Centre
Address
40 Rocklands Rd, North Sydney, NSW, 2060.
Country
Australia
Secondary sponsor category [1] 287222 0
Charities/Societies/Foundations
Name [1] 287222 0
Waikato Medical Research Foundation
Address [1] 287222 0
Waikato Hospital
PB 3200
Hamilton 3240
New Zealand
Country [1] 287222 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290380 0
St Vincent's Hospital
Ethics committee address [1] 290380 0
Ethics committee country [1] 290380 0
Australia
Date submitted for ethics approval [1] 290380 0
05/06/2013
Approval date [1] 290380 0
26/06/2013
Ethics approval number [1] 290380 0
13/059
Ethics committee name [2] 292872 0
Southern Health and Disability Ethics Committee
Ethics committee address [2] 292872 0
Ethics committee country [2] 292872 0
New Zealand
Date submitted for ethics approval [2] 292872 0
Approval date [2] 292872 0
11/08/2014
Ethics approval number [2] 292872 0
14/STH/99

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45394 0
Dr April Wong
Address 45394 0
Breast & Surgical Oncology at The Poche Centre,
40 Rocklands Rd, North Sydney
NSW 2060.
Country 45394 0
Australia
Phone 45394 0
+61 2 9911 7381
Fax 45394 0
Email 45394 0
[email protected]
Contact person for public queries
Name 45395 0
Julia Hoffman
Address 45395 0
Breast & Surgical Oncology at The Poche Centre,
40 Rocklands Rd, North Sydney
NSW 2060.
Country 45395 0
Australia
Phone 45395 0
+61299117312
Fax 45395 0
Email 45395 0
[email protected]
Contact person for scientific queries
Name 45396 0
April Wong
Address 45396 0
Breast & Surgical Oncology at The Poche Centre,
40 Rocklands Rd, North Sydney
NSW 2060.
Country 45396 0
Australia
Phone 45396 0
+61 2 9911 7381
Fax 45396 0
Email 45396 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data contains personal information which renders participants readily identifiable.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe role of breast reconstruction choice on body image patient-reported outcomes at four years post-mastectomy for breast cancer: A longitudinal prospective cohort study.2022https://dx.doi.org/10.1002/pon.5776
EmbasePatient-reported health-related quality of life outcomes following mastectomy for breast cancer, with immediate, delayed or no breast reconstruction: Four-year follow-up from a prospective cohort study.2023https://dx.doi.org/10.1016/j.breast.2023.08.001
N.B. These documents automatically identified may not have been verified by the study sponsor.