Choice of breast reconstruction (immediate, delayed or none) and quality of life for women undergoing mastectomy and radiotherapy for breast cancer.

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).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000045617

Acronym

QoLID (Quality of Life for Immediate, Delayed or declined breast reconstruction)

Enrollment

102

Registered

2014-01-17

Start date

2013-07-05

Completion date

2016-05-04

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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

Outcome results