A Dietitian Survivorship Clinic for Early-Stage Breast and Gynaecologic Cancer Survivors: A Dietetic Protocol for the Linking You to Support and Advice (LYSA) Randomised Controlled Trial

Introduction

Breast cancer is reported to make up 30% of all invasive cancer incidences in Ireland, with the 5-year observed survival being 78%¹. The 5-year observed survival in cervix cancer is 63% and uterus cancer is 71%¹. Advances in treatment and early detection have seen improvements in 5-year net survival, however this has also seen the insufficient, uncoordinated management of late and long-term effects of treatment^1,2. These effects encompass a wide range of symptoms, including physiological, psychological, cognitive, social, sexual, and nutritional challenges³. They may be equal or more disabling than a cancer diagnosis and its treatment and can significantly affect quality of life⁴. Furthermore, an individual’s transition from “active patient” to “survivor” is often challenging and associated with lifestyle and behavioural changes, including those related to diet and nutrition^5–7. In Ireland, cancer survivorship is regarded as a distinct and important phase of the cancer journey and a priority in the National Cancer Strategy (2017–2026) and it is broadly accepted that a cancer survivor is defined as a person “living with and beyond cancer”, from the point of diagnosis and continuing until the end of life⁸.

Chemotherapy receipt, menopausal status and adjuvant endocrine therapy are all proposed to be major contributors to alterations in body compositions throughout the cancer journey^7,9–14. Furthermore, these factors play a key role in the treatment of gynaecologic cancers^15,16. The use of an adjuvant endocrine therapy, such as a selective oestrogen receptor modulator (SERM) or an aromatase inhibitor (AI) can reduce the risk of breast cancer recurrence by 30–50% after 5 years of therapy and improve disease free survival^14,17. These adjuvant endocrine therapies are associated with side effects that impact quality of life, physical activity, sleep and mood, as well as accelerating menopausal status and symptoms^4,18. Whilst the impact of chemotherapy and radiotherapy on body composition has been well documented, literature around the impact of adjuvant endocrine therapy is limited in comparison. Body composition alterations include decreasing lean tissue mass and increasing adipose tissue mass, with Aleixo et al. identifying sarcopenia and obesity as important risk factors for adjuvant endocrine therapy toxicity and intolerance¹⁹. Furthermore, sarcopenia has been identified as an independent factor in disease-free-survival and overall survival¹⁷. Weight gain after breast cancer is reported in up to 90% of patients¹⁴. It is widely reported that breast cancer survivors, those with Grade 2 or 3 obesity (defined as Body Mass Index [BMI] >35) have a worse survival compared to those with normal weight. There are inconsistent conclusions for the association of Grade 1 obesity (defined as BMI > 25) with survival outcomes¹⁹.

Changes in body composition and dietary quality in breast and gynaecologic cancer survivors are due to a myriad of complex factors including genetic predisposition, socio-demographic factors, menopausal status, hormone-receptor status, clinical presentation and treatment modality. There is well documented evidence that body composition parameters, including lean tissue mass and adipose tissue, are suggested to be predictors of survival. In light of this, the National Comprehensive Cancer Network’s Survivorship Guidelines recommend that a multi-disciplinary approach is used and that providers should be competent advising survivors how to achieve an optimal body composition, including low overall body fat and higher amounts of muscle mass²⁰. Adjuvant therapies, including endocrine therapies, have significantly improved survival rates in female cancers, but also lead to a range of short- and long-term nutritional risks. These nutritional risks extend beyond those traditionally associated with cancer treatment, including increased risk of bone disease, cardiovascular disease, obesity and metabolic disturbances secondary to their treatment^21–24. These are further compounded by treatment induced menopause²⁵. The unique nutritional challenges faced by this cohort highlights the need for targeted dietetic care post-treatment to enhance long-term survival support chronic disease risk reduction and improve quality of life.

Despite this need, the implementation of high-quality dietetic outpatient survivorship care can be hindered by personnel shortages, access to the multidisciplinary team and travel barriers²⁶. A growing body of evidence supports the use of electronic and remote means as a supplement to usual care to aid the management of physical side effects, psycho-social effects, health promotion and disease prevention in post treatment care for cancer survivors²⁶. Digital solutions offer a promising approach to delivering holistic, patient-centered care, particularly in rural areas²⁷. Virtual consultations extend the reach of dietitians, reduce the burden of and need for in person visits and enhance patient engagement. The use of patient reported outcomes (PROs) allows healthcare professionals to monitor specific symptoms in real time and provide intervention in an efficient and timely manner. Dietetic interventions for cancer survivors are highly accepted^5,28,29 and have been shown to be feasible across a range of delivery modalities^30–40. In particular, telephone consultations have shown to be feasible and effective in oncology weight management research^30,32,34,38.

Despite growing recognition of the acceptability and feasibility of dietetic care in the post-treatment phase, there are currently no dedicated dietetic survivorship services embedded within the Irish healthcare system. This represents a critical gap, particularly given the well-documented nutritional challenges faced by cancer survivors, including changes in body composition, persistent treatment-related side effects, and increased risk of comorbidities. Although the LYSA Trial’s protocol paper has been published, it provides only a high-level summary of the dietetic intervention, offering limited insight into the practicalities of its implementation or the rationale behind its design⁴¹. The dietetic component of the LYSA intervention is both novel and complex, incorporating trigger-initiated follow-up, electronic patient-reported outcomes (ePROs), and a hybrid model of in-person and remote delivery. These elements reflect an innovative, patient-centred approach tailored to the real-world constraints of outpatient oncology care. Given the increasing emphasis on scalable and resource-efficient survivorship models, a dedicated protocol paper is warranted to describe the development, structure, and operationalisation of this intervention in detail.

This manuscript therefore aims to expand on the LYSA Trial’s primary protocol and address this gap by outlining the design, delivery, and rationale of a dietetic survivorship clinic tailored for breast and gynaecologic cancer survivors in an Irish outpatient oncology setting. In doing so, it offers a replicable model for integrating structured nutritional care into cancer survivorship services, with potential relevance both nationally and internationally as healthcare systems seek to optimise post-treatment support.

Materials and methods

Study design

The LYSA trial is an multi-centre randomized control trial (RCT) with an active comparator and experimental arm. LYSA assesses the feasibility of introducing a complex intervention incorporating a nurse-led and dietitian-led cancer survivorship clinic, symptom management through ePROs (Figure 1)⁴².

Figure 1. The LYSA Trial Study Design.

Dietetic intervention

Baseline and 12-Month Assessments:

The measurements tools used at baseline (T0) and 12-month (T12) survivorship clinics were the same for both arms as described in Table 1. The experimental arm was informed of their body composition and handgrip strength measurements as part of the intervention.

Table 1. The LYSA Dietetic Survivorship Clinic Intervention Schedule.

EXPERIMENTAL AND ACTIVE COMPARATOR STUDY SCHEDULE	0M	2M	4M	6M	8M	10M	12M
Online Diet Symptom Survey (ePRO) Weight Gain Concern, Physical Activity, MST Score and Body Weight (BMI)	AC E	E	E	E	E	E	AC E
Anthropometry: Weight, Height, Waist Circumference	AC E						AC E
Bioelectrical Impedance Analysis: Lean Tissue Mass, Adipose Tissue Mass, Lean Tissue Index, Fat Tissue Index	AC E						AC E
Muscle Strength: Hand Grip Strength	AC E						AC E
Dietary Intake: Multiple 24hr Dietary Recalls (1 in-person and 1 virtual) FFQ	AC E						AC E
Cancer-Specific Dietary Quality: WCRF/AICR Score	AC E						AC E
Body Weight Assessment	AC E						AC E
Cancer-Specific Diet Education	E						E
Personalised Nutritional Counselling (As Required)	E	E	E	E	E	E	AC E

AC: Active Comparator; E: Experimental; ePRO: electronic patient reported outcome; 24HR: 24 hour; FFQ: Food Frequency Questionnare; MST: Malnutrition Screening Tool; WCRF/AICR: World Cancer Research Fund/American Institute for Cancer Research

At or prior to the baseline (T0) clinic, the research nurse at each site sent the initial electronic survey to the participant’s designated email addresses via Castor EDC. This electronic survey aimed to evaluate various factors including body weight (kg), height (cm), Malnutrition Screening Tool score (MST)⁴³, weight gain concern, and physical activity status, utilising the Nordic Physical Activity Questionnaire-short⁴⁴. Upon survey completion, then attended the LYSA Survivorship Clinic in an outpatient regional cancer centre. Consultations were guided by survey results. Participants were assigned 60 minutes with the dietitian and 60 minutes with the nurse, reaching a maximum of five participants at each clinic site per week. The clinics included a mixture of participants at both baseline (T0) and 12 months (T12).

The dietitian completed the following anthropometric measurements and nutritional assessments during the baseline and 12-month outpatient appointments:

Body Mass Index: BMI was calculated by the participant’s weight in kg to the nearest 0.1kg, using the SECA Model 799 weighing scales, and their height in metres to the 0.01m, using SECA 206 stadiometer.

Waist Circumference: Waist circumference was measured to the nearest 0.1cm following the WHO STEPS Manual⁴⁵. The measurement was conducted three times, and the mean value was used.

Body Composition: Body composition was measured via bioelectrical impedance analysis (BIA) using the Fresenius Kabi Body Composition Monitor (BCM, Fresenius Medical Care, Bad Homburg, Germany). Measurements included lean tissue mass, lean tissue index, adipose tissue mass, fat tissue index, total body water, body cell mass, extracellular water and intracellular water. Participants who had pacemakers, implanted electronic devices or were pregnant were excluded from this measurement. The quality value for each measurement aimed to be > 85.

Handgrip Strength: Handgrip strength was measured using Jamar dynamometer (Jamar Hydraulic Hand Dynamometer, Model 091011725, Sammons Preston Roylan, Nottinghamshire, UK), using the second handle position as recommended by the American Society of Hand Therapists. The measurement was taken three times on each hand, alternating each measurement to allow a break. The average of three measurements was taken.

Multiple 24-Hour Dietary Recall: Two 24-hour dietary recalls were conducted using a weekday and weekend-day to allow accurate energy intake⁴⁶. The multiple pass method was used to standardised the 24 hour recall⁴⁷. The dietary recall was entered by the research dietitian into Nutritics software, for nutritional analysis.

Food Frequency Questionnaire: The EPIC NORFOLK FFQ was used (version CAMB/PQ/6/1205) to allow a comprehensive overview of each participant’s dietary habits over the course of one year⁴⁸. The participant’s completed the FFQ between their first baseline clinic visit and their follow up virtual clinic visit at T0 (Figure 2). Participants verbally reported their FFQ answers to the dietitian, who then entered them into a FETA template for nutritional analysis. Following their 12-month visit, participants returned the FFQ by post using a stamped and labelled envelope provided by the research dietitian.

Figure 2. The experimental arm flow through the LYSA trial.

24HR: 24-hour; BIA: Bioelectrical Impedance Analysis; BMI: Body Mass Index; FFQ: Food Frequency Questionnaire; LYSA: Linking You to Support and Advice; MST: Malnutrition Screening Tool; PCN: Personalised Nutritional Counselling; RD: Registered Dietitian; WCRF/AICR: World Cancer Research Fund/American Institute for Cancer Research; WGC: Weight Gain Concern.

Diet Quality: Diet quality is assessed using the WCRF/AICR standardized scoring system. The score includes 8 of the 10 Cancer Prevention Recommendations^49,50. The score specifically investigates BMI; waist circumference; physical activity status; intake of fruit, vegetables and fibre, percentage of total kilocalories from ultra-processed foods (UPFs), red and processed meat, sugar sweetened beverages and alcohol; and breast-feeding history^50,51. Each recommendation is scored as 1 (meeting recommendation), 0.5 (partially meeting recommendation) or 0 (not meeting recommendation) points^49–51. The scores range from 0 to 8 points, with higher scores reflecting greater adherence to recommendations. The dietitian calculated this score using anthropometric data, 24 hour recall dietary intake and food frequency questionnaire from baseline and 12 months. Scores from the UPF recommendation were calculated as tertiles, using the complete data set from 24-hour dietary recalls at baseline and 12 months. Dietitians manually calculated the total percentage of kilocalories from UPF consumed using Nutritics software.

Experimental arm intervention

Following the baseline anthropometric and nutritional assessments, the experimental arm received a written “Nutrition Pack” containing “Healthy Eating For Cancer Survivors”,⁵² a booklet containing the WCRF Recommendations and healthy recipes; the Health Service Executive (HSE) Weekly Low Risk Guidelines for Alcohol; Let’s Get Active Leaflet; and two sample walking programmes. The information was verbally relayed to participants by the dietitian via a telehealth platform, which allowed for information to be described and adapted to fit the individual’s own circumstances. Following this education session, the experimental arm received personalised nutritional counselling following the Nutrition Care Process⁵³ and the behaviour change model⁵⁴ to ensure that dietetic care was standardised across both sites.

Following the Nutrition Care Process, Nutrition Assessment and Diagnosis was conducted at the baseline outpatient visit. At the baseline virtual visit (Figure 2), using the behavioural change model⁵⁴, motivational interviewing⁵⁵ and shared decision-making⁵⁶, the Nutrition Intervention was conducted. This determined the dietetic prescription, formulated achievable goals and directed action. Nutrition Monitoring and Evaluation was conducted using the trigger-initiated ePROs every 2 months. This was assessed through electronic surveys, received via email.

ePROs trigger system

The ePROs collected at baseline and month 12 for both arms, and additionally at 2, 4, 6, 8, 10 for the experimental arm, were translated into a colour-coordinated trigger system. There was a maximum of two dietitians at each site conducting dietetic consultations using a standardised approach.

Dietetic ePROs survey questions were broken into two sections: 1) diet and 2) exercise, with questions directly translating into the trigger scoring system (Table 2).

Table 2. Dietetic ePRO Survey Questions.

Section	Question	Possible Answers	Linked Trigger:
Diet	1. Have you lost weight recently without trying?	Yes No Unsure	MST Score
	2. If yes, how much weight have you lost? (kg/lbs)	1-5kg (2-12lbs) 6-10kg (13-24lbs) 11-15kg (24-33lbs) >15kg (34lbs or more) Unsure	MST Score
	3. Have you been eating poorly because of a reduced appetite (eating less food at mealtimes, eating less often)?	Yes No	MST Score
	4. What is your weight today?	________ kg	BMI
	5. Are you concerned about weight gain?	Yes No Unsure	WGC
Exercise	Physical Activity 1. In general, over the last month how many minutes per week have you spent walking?	_______ Total minutes per week	No trigger
	Moderate-Vigorous Physical Activities 2. On a typical week, how much time do you send in total on moderate and vigorous physical activity, where your heartbeat increases and you breathe faster? Examples include: brisk walking, cycling as a means of transport or as exercise, heavy gardening, cleaning-heavy (washing windows, vacuuming, mopping) or recreational sports (badminton, tennis, dancing)?	Only include activities that lasted at least 10 minutes at a time. Less than 75 minutes Between 75 minutes and less than 150 minutes More than 150 minutes	No trigger
	Vigorous Physical Activities 3. How much of the time that you spend on physical activities in a typical week, which you indicated above, do you spend in total on vigorous physical activities? This includes activities that require hard physical effort, get your heart racing, make you sweat and breathe much harder than normal (e.g. swimming, hiking, jogging (at 6mph), running, bicycling fast (14-16mph), cardio training, weight- lifting, carrying heavy loads, shovelling or team sports such as basketball or soccer games, tennis).	Only include activities that lasted at least 10 minutes at a time. Less than 75 minutes Between 75 minutes and less than 150 minutes More than 150 minutes	No trigger

BMI: Body Mass Index; kg: kilograms; lbs: pounds; MST: Malnutrition Screening Tool; WGC: Weight Gain Concern

Participants triggered a nutritional pathway if they had: an MST score of 2-7; BMI >30; or a BMI 25.5-30kg/m² and weight gain concern (Figure 2).

The research nurse used the R Project for Statistical Computing and the RStudio integrated development environment (IDE) statistical software packages to produce a trigger list for research dietitians (Figure 3). If participants triggered, they were contacted by the research dietitian and a review was conducted using the telehealth platform T-Pro or via telephone consultation. Participants were contacted by the research dietitian up to three times within a week of the trigger. If participants did not make contact, they were classed as a “did not attend” (DNA) and were reviewed at the next survey.

Figure 3. The active comparator arm flow through the LYSA trial.

24HR: 24-hour; BIA: Bioelectrical Impedance Analysis; BMI: Body Mass Index; FFQ: Food Frequency Questionnaire; LYSA: Linking You to Support and Advice; MST: Malnutrition Screening Tool; PCN: Personalised Nutritional Counselling; RD: Registered Dietitian; WCRF/AICR: World Cancer Research Fund/American Institute for Cancer Research; WGC: Weight Gain Concern.

The research dietitians had access to the nursing trigger list, which included symptoms such as fatigue, urinary urgency, constipation, diarrhoea, insomnia and fear of recurrence, to allow for a comprehensive dietetic assessment. Nutritional counselling was adapted to the specific trigger, and the subsequent dietetic assessment that was conducted. Overall, nutritional counselling focused on optimal body composition, including muscle mass and bone mineral density, regardless of body weight, through protein and calcium intake. Protein intake was targeted at 1.5 – 2.0g Protein per kilogram of body weight per day (kg/BW/d)⁵⁷ and standard nutrition support advice, as per the National Clinical Guideline 22⁵⁸, was given to participants with an MST >2 and/or a BMI <18.5, including food fortification and the use of oral nutritional supplements when required. For participants with MST >2 and/or a BMI <18.5, a goal of 25-30kcal and 1.5 – 2.0g Protein per kilogram of body weight was set, as per ESPEN Guidelines⁵⁹.

For participants with BMI >=25.5 and WGC or BMI >30, behavioural change and motivational interviewing was incorporated as part of the care plan, as per the INDI Position on Optimal Approaches to Adult Weight Management Services in Ireland⁶⁰. Stable dietary and meal patterns were established focusing on optimal protein intake and where appropriate, recommendations included up to a 600kcal daily energy deficit⁶⁰. SMART (specific, measurable, achievable, relevant and timebound) goals were established at each consultation, following a patient-led approach. At subsequent trigger-initiated consultations, these SMART goals were evaluated, with external triggers and antecedents to eating behaviours identified. In individual cases where clinical judgement dictated appropriate, the dietitian could review before the next 2-month survey.

The experimental arm completed their endpoint survey at 12 months and were invited to attend the 12-month Survivorship Clinic. Participant results were compared from baseline and if clinically appropriate, a final personalised nutritional counselling session was conducted. For participants where clinical judgement dictated appropriate, a consented referral to the relevant Community Nutrition and Dietetic Service was made for nutrition support or weight management.

Active comparator arm

Following the baseline anthropometric and nutritional assessments, participants randomized to the active comparator arm underwent routine surveillance. They completed their endpoint survey at 12 months, assessing MST score, body weight, weight gain concern and physical activity status (Figure 3). The ePROs were translated into a colour-coordinated trigger system by the research nurse.

Upon completion of their 12-month survey, the active comparator arm was invited to attend the 12-month (T12) Outpatient Survivorship Clinic. Participants who had triggered at their 12-month survey were offered a personalised nutritional counselling session which was conducted at the point of study completion (Figure 3). They also received the same Nutrition Pack as the experimental arm, posted to them upon completion of the study. For active comparator arm participants where clinical judgement dictated appropriate, a consented referral to the relevant Community Nutrition and Dietetic Service was made for nutrition support or weight management.

Discussion

The primary aim of the Linking You to Support and Advice (LYSA) randomized controlled trial is to evaluate, for the first time, the feasibility of nurse- and dietitian-led survivorship clinics for early-stage breast and gynaecologic cancer survivors in Irish cancer centres, using electronic patient-reported outcomes (ePROs). The purpose of this protocol paper is to describe the implementation of the dietetic intervention in detail to contribute to the growing body of literature around supportive care.

Meeting the nutrition-specific needs of this growing cohort of cancer survivors may prove a challenge in today’s climate. Research globally has reported that access to a dietitian is a barrier: in breast and gynaecologic survivors, only 12–34% reported engaging with a dietitian at least once post-treatment^28,29 but 35–60% reported moderate to severe nutrition impact symptoms²⁹, perceived muscle loss, dietary problems and the desire to engage with a dietitian²⁸. The impact of body composition as a prognostic outcome has been well documented⁵⁷, but it is still not incorporated into routine care within the Irish setting. A greater effort should be in place to make body composition assessment accessible to all healthcare and medical professionals, not only through primary curative treatment but particularly following its completion, to monitor the impact and effect of the former.

Sarcopenia is common in breast and gynaecologic cancers, affecting 11–67% of patients^65–71. It is now recognised to include muscle strength and performance, no longer solely characterised by low muscle mass⁵⁷. Low muscle mass has been associated with increased toxicity-related endocrine therapy discontinuation (OR 2.18, p = 0.036), subsequently worse ipsilateral breast tumour recurrence and disease-free survival (HR 9.47, p = 0.002; HR 4.53, p = 0.001)¹⁴, and a 71% increased mortality risk in breast cancer survivors⁶⁷. Sarcopenic obesity, characterised by high adiposity and low muscle mass, further increases mortality and treatment complications, with BMI proving an unreliable prognostic factor^14,72. Chemotherapy contributes to metabolic syndrome in 73% of patients and increases inflammation by 32%²¹, while cancer treatments can also accelerate bone loss, with a 21% reduction in bone density within 6 months^21–24. Whilst chemotherapy and endocrine therapy are associated with increased visceral adipose tissue (VAT) in breast cancer^69,70 research examining the effects of endocrine therapy on muscle mass in breast cancer has been variable, with one study showing an increase muscle mass⁷⁰ but others demonstrated a decrease in skeletal muscle index^73,74. Further long-term research is warranted to contribute to the understanding of endocrine therapies relationship with body composition. The LYSA Trial will provide the first Irish data set, comparing changes in muscle mass during the first years of endocrine therapy (active comparator arm) and the impact of dietary counselling (experimental arm) for a 12 month period.

Oncology dietitians, who have upskilled in the area of body composition analysis, are in the unique position to assess, diagnose, intervene and monitor important prognostic factors, such as muscle mass and adipose tissue mass. The impact of a body composition assessment should not be ignored, however in routine clinical assessment due to a myriad of factors, anthropometric measurements are limited to weight, height and BMI. The breast and gynaecologic cancer cohort may be particularly at risk of sarcopenic obesity due to the impact of menopausal status and adjuvant endocrine therapy as well as weight gain during systemic anti-cancer treatment. Given the inconsistencies of BMI as a prognosis factor in individuals with overweight or obesity in relation to DFS, assessment of body composition has evolved to be a more informative approach¹⁹. This protocol details the use of practical and accessible techniques for assessing body composition in the outpatient setting, including handgrip strength (HGS), waist circumference (WC), and bioelectrical impedance analysis (BIA). These methods are not only feasible for routine clinical use by dietitians in acute and outpatient settings but also hold promise as valid indicators of nutritional and functional status. While each has known limitations—such as HGS being potentially affected by aromatase inhibitor–induced arthralgia, or BIA being contraindicated in certain clinical scenarios—this protocol offers a structured approach to their use, supporting consistency and reliability. Importantly, the study has the potential to compare and validate HGS and WC against BIA, and to explore how these accessible tools correlate with clinical outcomes. In doing so, this work may provide an evidence base for inexpensive, scalable methods that can enhance dietetic practice and improve patient care.

Weight management in this patient cohort may be considered novel or even taboo among healthcare providers. Traditionally, weight maintenance or gain has been a key dietary goal during systemic anti-cancer treatment. Outside of the acute oncology setting, access to specialist oncology dietitians is often limited. Excess adipose tissue increases the risk of cancer recurrence, particularly in breast and gynaecologic cancer survivors, and raises the likelihood of chronic diseases such as type 2 diabetes and cardiovascular disease—the leading cause of death among postmenopausal women⁷⁴. A recent study of 1,000 women aged 50–69 found that 90% desired weight loss, and over 70% engaged in dieting behaviours⁷⁵. In Ireland, 37% of cancer survivors reported trying or following an alternative diet, while 30% avoided specific foods²⁸. These findings highlight the need for effective, sustainable weight management interventions that improve body composition and dietary quality. Such interventions could offer a three-fold benefit: reducing cancer recurrence risk, lowering chronic disease risk, and preventing harmful dieting behaviours.

The availability of oncology dietitians remains a challenge. In U.S. cancer centres, the patient-to-dietitian ratio is 1:2,380, with only 8.7% offering tele-dietetics or e-coaching⁷⁶. In Ireland, the ratio is even higher at 1:4,500⁷⁷. Ireland has eight designated cancer centres, with four in the capital and 14 additional centres with oncology or haematology consultants⁸. The Irish Society of Clinical Nutrition and Metabolism reported that in 2019, only five full-time equivalent oncology dietitians worked outside the capital, and no dedicated dietetic survivorship services existed in any centre⁸. Innovative and feasible pathways for dietetic intervention and support are being explored globally^78–81 however, to our knowledge, this is the first dedicated dietetic survivorship clinic based in an Irish regional cancer centre using ePROs to reach survivors in both rural and urban areas.

The sphere of telemedicine and telehealth has grown rapidly in the wake of COVID19 pandemic. If used effectively as a supplement to standard routine care, the use of electronic patient reported outcomes can allow healthcare professionals to closely monitor cancer survivors and related symptoms and intervene in a timely fashion. In 2023, a systematic review analysing over 15 randomised control trials (n=2363 cancer survivors) reported that mobile health dietary interventions may be an effective strategy for cancer survivors⁸². The review reported significantly improved quality of life (p=0.04), reduced weight (p=0.01) and waist circumference (p<0.01), however the trials included did not report lean body mass or fat tissue mass as an outcome⁸². The trials conducted the interventions over a variety of timepoints; from 4 weeks to 24 months⁸². Interestingly, only 3 RCTs reported interventions that were provided by a dietitian, other interventions were provided by cancer survivors, fully automated systems, medical students and unspecified healthcare professionals⁸². The review concluded that larger scale RCTs with rigorous study design are needed to examine the effect of dietary interventions delivered via mobile health interventions. The LYSA study design aligns with the EU Beating Cancer Plan which focuses on innovation, by tapping into the potential that digitalisation and new technologies offer.

Traditional survivorship care often relies on body weight or BMI as crude proxies for nutritional status, which can mask important changes in lean tissue and fat distribution—especially in female cancer survivors exposed to endocrine therapy and treatment-induced menopause. This protocol addresses these limitations by incorporating BIA to assess body composition, offering a more sensitive and nuanced measure of nutritional status than weight alone; including muscle strength measurements to capture functional outcomes, which are critical indicators of sarcopenia and quality of life⁵⁷. The ability to track longitudinal changes in these parameters over 12 months, rather than relying on cross-sectional or self-reported data, is a significant strength to this protocol. Moreover, integrating body composition assessment within a comprehensive nutritional framework – including dietary intake, cancer-specific dietary quality, nutritional risk, and electronic patient reported outcomes – addresses a critical gap, as at the time of writing, no dietetic protocol encompassed this scope, or if one exists, it remains inaccessible due to lack of publication.

Conclusion

The LYSA randomized controlled trial represents a significant step toward addressing the gaps in survivorship care for early-stage breast and gynecologic cancer survivors in Ireland. By integrating dietetic and nursing support with ePROs this study aims to provide a scalable, accessible model for a dietetic survivorship service. Given the impact of body composition and dietary quality on cancer recurrence and chronic disease, this protocol emphasizes the importance of a comprehensive dietetic assessment and intervention in this cohort. With limited access to oncology dietitians, LYSA explores feasible dietary interventions and digital health strategies to enhance survivorship care. By aligning with the EU Beating Cancer Plan, this trial leverages innovation to improve patient outcomes and inform future models of care.

Institutional review board statement

The study was conducted in accordance with the Declaration of Helsinki and approved by the Clinical Research Ethics Committee of the University Teaching’s Hospital [CREC] (ECM 4 (y) 20/10/20) and Galway Clinical Research Ethics Committee (121/21, 08/02/22).

Informed consent statement

Informed consent was obtained from all subjects involved in the study.