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.

BACKGROUND: Breast reconstruction (BR) improves women's health-related quality of life (HRQOL) following mastectomy for breast cancer, yet factors contributing to improved HRQOL remain unclear. This study aimed to explore the overall impact of mastectomy with or without BR on participants' perceptions of HRQOL over time in a cohort of women with high-risk breast cancer; to examine differences in mean HRQOL scores between immediate BR, delayed BR and no BR groups; to assess the influence of patient characteristics potentially associated with HRQOL scores; and to determine the feasibility of long-term collection of patient-reported outcome measures in clinical settings. METHODS: A prospective, longitudinal study of 100 women with high-risk breast cancer who underwent mastectomy with or without breast reconstruction and were likely to require post-mastectomy radiotherapy. Four validated patient-reported questionnaires, comprising 21 outcome measures relating to HRQOL, administered at baseline and up to 4 years post-mastectomy. Demographic, clinical and surgical data extracted from patient medical records. RESULTS: Consistently significant declines in perceptions of future health and arm symptoms, consistently significant improvements in treatment side effects, breast symptoms and fatigue, as well as significant improvements, compared to baseline, in social functioning and financial difficulties at 48 months. No significant differences in mean HRQOL scores between women given a choice of reconstructive options. CONCLUSION: Similar trajectories of HRQOL scores were found in women with high-risk breast cancer who were offered a choice of BR. Informed choice may be an independent contributing factor in long-term maintenance of most HRQOL indicators at their pre-mastectomy levels.

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.

OBJECTIVES: To examine the impact of breast reconstruction on women's perceptions of body image over time and to assess the influence of sociodemographic variables on body image. METHODS: A prospective, longitudinal cohort study, using validated breast cancer-specific questionnaires, to compare patient-reported outcomes in women choosing immediate (n = 61), delayed (n = 16) or no (n = 23) breast reconstruction. RESULTS: One hundred women completed baseline questionnaires that included items on body image; 30 women completed all four annual follow-up sets, while 20 women completed baseline only. The three groups were well matched at baseline and similar trajectories in body image measures were identified over 48 months in all groups. At 12 months post-mastectomy, significant changes were seen in eight of the 10 subscales; this reduced to seven subscales at 24 months and four at 36 months. By 48 months, only three subscales remained significantly different to baseline scores: women remained less vulnerable and had fewer limitations (improved outcomes); the one worse outcome was persistently higher levels of arm concern. Three of the sociodemographic variables (health insurance, age and employment status) showed significant inter-group differences at some time points. CONCLUSION: These findings suggest women recover from the negative impact of mastectomy on body image within four years of surgery, whether they have immediate, delayed or no reconstruction. Our results provide some indirect evidence that having a choice of BR options is important, regardless of the choice made. Four years appears to be a suitable follow-up period for future studies in this area.

Embedding electronic patient-reported outcome measures into routine care for patients with stage III MELanoma (ePROMs-MEL): protocol for a prospective, longitudinal, mixed-methods pilot study.

INTRODUCTION: The benefits of patient-reported feedback, using questionnaires that allow patients to report how they feel and function without any interpretation from healthcare professionals, are well established. However, patient-reported outcomes measures (PROMs) are not routinely collected in patients with melanoma in Australia. The aim of this study is to evaluate the feasibility and acceptability of implementing electronic PROMs (ePROMs) into routine care from the perspectives of patients with stage III melanoma and their treating clinical team. METHODS AND ANALYSIS: A minimum of 50 patients and 5 clinicians will be recruited to this prospective, longitudinal pilot study (ePROMs-MELanoma). The study uses a mixed-methods approach (quantitative PROMs questionnaires and end-of-study surveys with qualitative interviews) and commenced in May 2021 in surgical and medical melanoma clinics at two sites in metropolitan Sydney, Australia. The primary outcomes are measures of feasibility and acceptability, comprising descriptive questionnaire completion statistics, and proportion of patients who reported that these PROMs were easy to complete and measured items they considered important. Clinician and clinic staff views will be canvassed on the appropriateness of these PROMs for their patients, change in referral practice and uptake and incorporation into routine practice. Secondary aims include measurement of improvements in patients' emotional and physical health and well-being, and utility of real-time data capture and clinician feedback. All participants will complete the Distress Thermometer and EQ-5D-5L questionnaires in the clinic using a tablet computer at baseline and two to three subsequent follow-up appointments. Participants who report a score of 4 or higher on the Distress Thermometer will be triaged to complete an additional three questionnaires: the QLQ-C30, Depression, Anxiety and Stress Scale and Melanoma Concerns Questionnaire-28. Results will be generated in real time; patients with psychosocial distress or poor quality of life will discuss possible referral to appropriate allied health services with their clinician. Thematic analysis of interviews will be conducted. ETHICS AND DISSEMINATION: Ethics approval obtained from St Vincent's Hospital Human Research Ethics Committee on 19 September 2019 (2019/ETH10558), with amendments approved on 8 June 2022. Patient consent is obtained electronically prior to questionnaire commencement. Dissemination strategies will include publication in peer-reviewed journals and presentation at international conferences, tailored presentations for clinical societies and government bodies, organisational reporting through multidisciplinary meetings and research symposia for local clinicians and clinic staff, and more informal, lay reports and presentations for consumer melanoma representative bodies and patient participants and their families. TRIAL REGISTRATION NUMBER: ACTRN12620001149954.

Adjuvant immunotherapy recommendations for stage III melanoma: physician and nurse interviews.

BACKGROUND: Adjuvant immunotherapy is revolutionising care for patients with resected stage III and IV melanoma. However, immunotherapy may be associated with toxicity, making treatment decisions complicated. This study aimed to identify factors physicians and nurses considered regarding adjuvant immunotherapy for melanoma. METHODS: In-depth interviews were conducted with physicians (medical oncologists, surgeons and dermatologists) and nurses managing patients with resected stage III melanoma at three Australian tertiary melanoma centres between July 2019 and March 2020. Factors considered regarding adjuvant immunotherapy were explored. Recruitment continued until data saturation and thematic analysis was undertaken. RESULTS: Twenty-five physicians and nurses, aged 28-68 years, 60% females, including eleven (44%) medical oncologists, eight (32%) surgeons, five (20%) nurses, and one (4%) dermatologist were interviewed. Over half the sample managed five or more new resected stage III patients per month who could be eligible for adjuvant immunotherapy. Three themes about adjuvant immunotherapy recommendations emerged: [1] clinical and patient factors, [2] treatment information provision, and [3] individual physician/nurse factors. Melanoma sub-stage and an individual patient's therapy risk/benefit profile were primary considerations. Secondary factors included uncertainty about adjuvant immunotherapy's effectiveness and their views about treatment burden patients might consider acceptable. CONCLUSIONS: Patients' disease sub-stage and their treatment risk versus benefit drove the melanoma health care professionals' adjuvant immunotherapy endorsement. Findings clarify clinician preferences and values, aiding clinical communication with patients and facilitating clinical decision-making about management options for resected stage III melanoma.

Should I Have Adjuvant Immunotherapy? An Interview Study Among Adults with Resected Stage 3 Melanoma and Their Partners.

BACKGROUND: Adjuvant immunotherapy is a new treatment paradigm for adults with resected stage 3 melanoma. However, therapy can lead to long-term adverse health impacts, making immunotherapy decisions difficult. This study aimed to explore patients and their partners' views when considering whether to commence adjuvant immunotherapy. METHODS: Focus groups and in-depth interviews were conducted among adults with resected stage 3 melanoma and their partners between August 2019 and April 2020. Factors important to adjuvant immunotherapy decision making were explored. Recruitment continued until data saturation, with thematic analysis performed. RESULTS: Thirty-six participants were recruited across two cohorts, including 24 patients (mean age 65 years, 71% male), and 12 partners (mean age 69 years, 75% female). Twenty-two patients (92%) received adjuvant immunotherapy, two (8%) declined. Five patients (21%) ceased treatment early because of toxicity. Five themes about adjuvant immunotherapy were common to all participants: (1) life and death; (2) perceived risks and benefits; (3) seeking information; (4) healthcare team relationship; and (5) immunotherapy treatment considerations. Prolonging life was the primary consideration, with secondary concerns about treatment burden, timing, costs and efficacy. CONCLUSIONS: This information can be used by clinicians to support melanoma treatment decision making.

Melanoma is a type of skin cancer that can be deadly. Treatment for melanoma involves surgery to remove it and can be followed by extra (adjuvant) immunotherapy, a type of drug that uses the body's immune system to fight any leftover melanoma. Immunotherapy can help a person live longer but has downsides or side effects that may need a person to take daily medication for life. We spoke to patients with melanoma and their partners to learn what was important to them when deciding to have immunotherapy. Living longer was most important, followed by concerns about treatment difficulties and costs. This information will help doctors and nurses discuss treatment options for melanoma with patients and their families.