ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

Breast

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

Not applicable - Observational study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline and at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-mastectomy.

Secondary outcome [1]

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]

Prior to mastectomy.

Secondary outcome [2]

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]

At baseline, 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-mastectomy.

Secondary outcome [3]

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]

At baseline and 6 months post final reconstruction.

Secondary outcome [4]

4. Rate of surgical and PMRT complications.

Timepoint [4]

Information on complications recorded from patient records throughout the trial.

Secondary outcome [5]

5. Significance of pain as experienced by patients, using Brief Pain Inventory and the Pain Catastrophizing Scale

Timepoint [5]

At baseline (pre-op), and at 1, 3, 12, 18, 24, 36, 48 and 60 months post-mastectomy.

Secondary outcome [6]

6. Overall rate (and cause-specific rates) of delay in delivery of adjuvant treatments.

Timepoint [6]

Data recorded from patient records throughout the trial.

Secondary outcome [7]

7. Long term outcomes up to five years (locoregional recurrence, disease free survival and overall survival).

Timepoint [7]

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?

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

Accrual to date

Final

102

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Mater Sydney - North Sydney

Recruitment postcode(s) [1]

2060 - North Sydney

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Waikato

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Friends of the Mater Foundation

Address [1]

Rocklands Rd, North Sydney, NSW, 2060.

Country [1]

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]

Charities/Societies/Foundations

Name [1]

Waikato Medical Research Foundation

Address [1]

Waikato Hospital
PB 3200
Hamilton 3240
New Zealand

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital

Ethics committee address [1]

390 Victoria St, Darlinghurst, NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/06/2013

Approval date [1]

26/06/2013

Ethics approval number [1]

13/059

Ethics committee name [2]

Southern Health and Disability Ethics Committee

Ethics committee address [2]

C/- MEDSAFE, Level 6 Deloitte House, 10 Brandon Street, PO Box 5013, Lambton Quay, Wellington 6145

Ethics committee country [2]

New Zealand

Date submitted for ethics approval [2]

Approval date [2]

11/08/2014

Ethics approval number [2]

14/STH/99

Summary

Brief summary

This study will assess the quality of life in women with breast cancer, from a surgical oncology practice in North Sydney, Australia, who undergo mastectomy and post-mastectomy radiotherapy (PMRT).

Study details
All participants in this study will be asked to complete a number of questionnaires over a period of 5 years post-mastectomy in order to assess quality of life, pain, aesthetic outcomes and clinical outcomes. If immediate breast reconstruction (IBR) is found to improve the quality of life of patients who are undergoing mastectomy and subsequent adjuvant treatments, then IBR could be offered as an option to breast cancer patients who are reasonable candidates for this procedure. This will be the first prospective cohort study in Australia to assess the quality of life of women undergoing mastectomy and PMRT, and allows for comparison of outcomes according to breast reconstruction choices - immediate, delayed or none.

Trial website

Trial related presentations / publications

Conference Presentation:
Title: "A prospective Quality of Life study of Immediate & Delayed breast reconstruction in women undergoing mastectomy and adjuvant radiotherapy for breast cancer (QoLID Study)"
2015 ANZ Breast Cancer Trials Group Annual Scientific Meeting in Perth, Western Australia.

Conference presentation:
Flitcroft K, Spillane A, Brennan M, Snook K, Costa D, Wong A. The importance of choice: A prospective evaluation of factors affecting preference for immediate, delayed or no reconstruction in the context of mastectomy and post-mastectomy radiotherapy for breast cancer. Presented at Association of Breast Surgeons Conference, Bournemouth England, June 2015. [Abstract published in Eur J Surg Onc; 41(6): S24].

Publication:
Flitcroft K, Brennan ME, Costa D, Wong A, Snook K, Spillane AJ. An evaluation of factors affecting preference for immediate, delayed or no breast reconstruction in women with high risk breast cancer. Psycho-oncology 16 Feb 2016. doi: 10.1002/pon.4087.

Public notes

Contacts

Principal investigator

Name

Dr April Wong

Address

Breast & Surgical Oncology at The Poche Centre,
40 Rocklands Rd, North Sydney
NSW 2060.

Country

Australia

Phone

+61 2 9911 7381

Fax

aprilwong80@gmail.com

Contact person for public queries

Name

Julia Hoffman

Address

Breast & Surgical Oncology at The Poche Centre,
40 Rocklands Rd, North Sydney
NSW 2060.

Country

Australia

Phone

+61299117312

Fax

Julia.Hoffman@melanoma.org.au

Contact person for scientific queries

Name

April Wong

Address

Breast & Surgical Oncology at The Poche Centre,
40 Rocklands Rd, North Sydney
NSW 2060.

Country

Australia

Phone

+61 2 9911 7381

Fax

aprilwong80@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	The role of breast reconstruction choice on body image patient-reported outcomes at four years post-mastectomy for breast cancer: A longitudinal prospective cohort study.	2022	https://dx.doi.org/10.1002/pon.5776
Embase	Patient-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.	2023	https://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.

Trial Review

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Documents added manually

Documents added automatically