Developing a PROM for axillary treatment for breast cancer v 1.0
Research type
Research Study
Full title
Development of a patient reported outcome measure (PROM) for breast cancer patients undergoing axillary treatment (PROM-Ax)
IRAS ID
326300
Contact name
Carmel Anandadas
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Modern breast cancer treatment often includes treatment to the lymph glands in the armpit with surgery or with radiotherapy. These treatments can cause short and long term problems with arm and shoulder function, such as pain, stiffness and swelling which can reduce quality of life. Patient reported outcome measures are questionnaires which are designed to capture the patient experience from the patient point of view. This study aims to develop a new patient reported outcome measure to assess the affects of breast cancer treatment on the arm and shoulder. Patients with experience of breast cancer treatment with surgery or radiotherapy will be eligible for the study.
The study will be conducted at the Christie NHS Foundation Trust over four stages.Stage 1. 20-30 individual interviews with participants with experience of treatment for breast cancer (a range of surgical and radiotherapy treatments) will be conducted. We aim to capture experiences of of these treatments including quality of life, symptoms and side effects.
Stage 2. Stage 1 will be used to create a draft item list which will be given to approximately 7 participants, who will undergo a cognitive interviews to check all items are clear and understood.
Participation in stage 1 and 2 is completed after the interview(s).
Stage 3. A draft PROM will be administered to approximately 120 participants who have or are receiving radiotherapy for breast cancer along with two existing questionnaires; BR23 and quick-DASH. Approximately 50 patients will be asked to repeat the draft PROM one week later to assess the stability of responses over time. Participants may take part between one and six time points, up to 1 year after study commencement.
Stage 4. The final PROM questionnaire will be pilot tested with approximately 10 patients.
The research is funded by Cancer Research UK.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
23/NW/0260
Date of REC Opinion
8 Sep 2023
REC opinion
Favourable Opinion