Participants will undergo an assessment of physical function and psychosocial wellbeing. Researchers will apply a triage algorithm, based on findings of assessment. Participants will be referred to one of three exercise-based rehabilitation pathways which will best meet their rehabilitation needs. Participants will be re-assessed after 12 weeks. System will be evaluated using RE-AIM framework.

PERCS Triage and Referral System

There is strong evidence that exercise can help improve physical and mental wellbeing after treatment for cancer. However, at present, people with cancer in Ireland are not given the opportunity to have an individual assessment of their physical and psychological wellbeing as part of standard care and are not routinely prescribed exercise-based rehabilitation.

The researchers will run and evaluate a system to i. assess physical and psychological wellbeing of people who have completed cancer treatment, ii. apply a rehabilitation triage system, based on findings of the assessment, iii. refer participants to one of three rehabilitation pathways, as per outcome of the triage process.

Rehabilitation pathways are as follows:

1. Participants who are currently active and have no cancer-specific impairments will receive advice from the physiotherapist on maintaining their current levels of activity.
2. Participants who are not active and have no cancer-specific impairments will be referred to a suitable community-based exercise programme. This programme must contain both resistance and aerobic training and should have some level of supervision from a fitness professional.
3. Participants who are not active and have ongoing cancer-specific impairments will be referred to an oncology specialist physiotherapist, funded through this work, at St James's Hospital for assessment and treatment.

All participants will be encouraged to visit www.cancerrehabilitation.ie for information through out the study. Participants will be reassessed 12 weeks after the initial assessment.

The implementation of this system will be evaluated using the RE-AIM framework.

Background During and following treatment for cancer, people can experience negative side-effects of treatment, including loss of fitness, weakness, fatigue and psychological issues such as depression and anxiety. There is strong evidence that exercise can help improve these symptoms. The impact of the COVID-19 pandemic means that many people who had cancer treatment since March 2020 may need additional support to achieve optimum physical and psychological wellbeing. At present, people with cancer in Ireland are not given the opportunity to have an individual assessment of their physical and psychological wellbeing as part of standard care and are not routinely prescribed exercise-based rehabilitation.

Aim To run and evaluate an exercise-based rehabilitation triage and assessment clinic for people who had cancer treatment since the beginning of the COVID-19 pandemic.

Study Design:

Patients who were diagnosed with cancer in St James Hospital since March 2020 will be invited to participate in the study. Participants will attend an appointment with a physiotherapist, who will assess their physical and mental wellbeing. On the basis of the assessment findings, participants will be assigned to one of three categories, which will determine their ongoing rehabilitation plan. The three categories are as follows:

1. Participants who are currently active and have no cancer-specific impairments will receive advice from the physiotherapist on maintaining their current levels of activity.
2. Participants who are not active and have no cancer-specific impairments will be referred to a suitable community-based exercise programme. This programme must contain both resistance and aerobic training and should have some level of supervision from a fitness professional.
3. Participants who are not active and have ongoing cancer-specific impairments will be referred to an oncology specialist physiotherapist, funded through this work, at St James's Hospital for assessment and treatment.

All participants will also be advised to visit a website designed by the PERCS research group through a co-design process with patient representatives (www.cancerrehabilitation.ie.) Participants will receive a follow-up phone call one week after the first assessment and will then be re-assessed 12 weeks after the first assessment. A further follow-up phone call will be conducted, if the PERCS research team feel it is needed.

The assessment and triage clinic will be assessed using a framework for evaluating intervention; this will look at how the intervention was implemented and how it will best operate in future practice.

A feasibility and implementation study of the PERCS triage and referral system. Participants are triaged into one of three groups, but the outcomes of the groups will not be compared from an intervention perspective. The system will be evaluated as a whole.

Implementation study designed to operate closely to clinical practice: no masking appropriate or required.

Personalised Exercise Rehabilitation for Cancer Survivorship

Evaluation of system Reach, Effectiveness, Adoption, Implementation, Maintenance

Referral - Eligible referral rate from prehabilitation group

Referral - Eligible referral rate from clinical teams

Referral outcome - time frame and acceptance

Physical activity levels assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale

Readiness to change assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale

Physical activity self efficacy assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale

Self-reported function. Scale from 0 - 10, higher score indicates higher perceived ability to do task

Anxiety \& depression; Scale from 0 - 21, higher score indicates higher levels of anxiety and/or depression.

Irish Cancer Society

National Cancer Control Programme, Ireland

Trinity St James's Cancer Institute, Dublin, Ireland

Royal College of Surgeons, Ireland

Technological University Dublin, Ireland

La Trobe University, Melbourne, Australia

Wellcome Trust-HRB Clinical Research Facility, St James's Hospital, Dublin, Ireland

University of Dublin, Trinity College

Assistant Professor

Nervous System Diseases

All Conditions

Peripheral Nervous System Diseases

Neuromuscular Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support.

The 10-week intervention includes:

Individualized Exercise Program: Each participant will receive an individualized progressive exercise program that includes cardiovascular and strength training as well as balance and desensitization exercises and will be adjusted to the needs of the patient.

Remote Monitoring: Fitbit™ devices will be used to monitor patients' physical activity over the duration of the program. Fitness trackers can promote behaviour change and allows for self-monitoring and feedback to the participant.

Remote Person-to-Person Clinical Support: Participants will have scheduled remote check-ins and health coaching sessions with their assigned RKin over Microsoft Teams (MSTeams) on weeks 2, 3, 4, 6, and 8 of the intervention. During these calls, the RKin will review, adapt, and progress the exercise program as needed, discuss and develop goals for the following week, and identify potential barriers and solutions in achieving their goals.

EX-CIPN

Eric Antonen

The goal of this clinical trial is to learn if the EX-CIPN exercise-based intervention is feasible, acceptable, and safe in participants with persistent chemotherapy-induced peripheral neuropathy (CIPN). It will also give insight on the effectiveness of the exercise intervention in treating CIPN symptoms. The main questions it aims to answer are:

* Is EX-CIPN safe, acceptable, and feasible in cancer survivors experiencing persistent CIPN?
* Are the study design and methods feasible (recruitment and retention rates, feasibility of data collection and procedures)?

Researchers will provide all participants with the exercise-based intervention.

Participants will:

* Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention
* Complete a 10-week remote, individualized exercise program
* Receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention
* Wear a FitBit throughout the study to track physical activity and promote behaviour change

Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN)

EX-CIPN: An Exercise-based Rehabilitation Intervention to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Assessed based on CONSORT criteria through a screening log that tracks data collected of all screened patients. Eligibility screening will be performed to identify eligible consented and eligible non-recruited individuals with non-recruitment reasons documented. Number of participants consented and enrolled will be tracked each month.

Retention rates will be calculated as the proportion of participants that attend each assessment time point. The investigators will also examine rates of complete and missing data.

Assessed through health coaching call attendance, Fitbit™ usage, and self-report completion of weekly exercise plan

All adverse events will be scored on the CTCAE version 5.0 and documented during weekly appointments and at follow-up assessments with the Registered Kinesiologist (RKin). Assessment, tests, and all exercises will be stopped at any time if any pain or discomfort is experienced.

Measured using the numeric pain rating scale (NPRS). Scored on a 1-10 scale, 1 being no pain and 10 being worst pain imaginable.

Measured using the European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy (EORTC CIPN-20) questionnaire. Results are scored on a scale between 20-80 with higher scores meaning worse outcomes.

Measured using the Rasch-built Overall Disability Scale for patients with chemotherapy-induced peripheral neuropathy CIPN-RODS. Results are scored on a scale between 0-56 with lower scores meaning worse outcomes.

Measured via handgrip dynamometry or grip strength test (GST).

Measured by a 30-second sit to stand test (30-s STS).

Measured using the Short Physical Performance Battery (SPPB) Balance Test. The SPPB balance test provides a score from 0 to 4 with lower scores meaning worse outcomes.

Measured using the Four-Metre Gait Speed Test.

Measured using a 6-minute walk test (6MWT).

University Health Network, Toronto

Neoplasms

Gland and Hormone Related Diseases

Symptoms and General Pathology

Musculoskeletal Diseases

Wounds and Injuries

Thyroid Neoplasms

Thyroid Diseases

Head and Neck Neoplasms

Neck Pain

Pain

Shoulder Pain

Dyskinesias

Accessory Nerve Injuries

Arthralgia

Joint Diseases

Neurologic Manifestations

Accessory Nerve Diseases

Cranial Nerve Diseases

Cranial Nerve Injuries

Craniocerebral Trauma

Trauma, Nervous System

Participants in the control group will receive usual care ( standard physical therapy program)

Particiapnts in intervevention group will receive both usual care and myofascial release techniques

Sternocleidomastoid, Upper trapezius, Suboccipital region, Scalenes, Pectoral release, Scapular and hyoid mobilization techniques.

Duration: 6 weeks, 1 supervised session per week, and the session lasted 30 minutes.

Myofascial Release Technique

Therapeutic exercise: passive and active range of motion, strengthening and postural exercise in order to improve shoulder and cervical mobility, muscle flexibility, strength and endurance, postural control and movement patterns; 2) stretching of pectoral muscles and serratus anterior; 3) scar tissue massage to reduce scar tissue's stiffness.

Duration of the intervention: 6 weeks (1 supervised session and 2 individual per week). Each exercise will be done 1-3 sets and 5-10 repetitions.The session lasted 30 minutes.

Exercise diary will be utilized in order to follow the exercise program.

Exercise

Circular, Up and Down, Side to Side technique

Scar Tissue Massage

Ferhat SIMSEK, PhD(c)

Ali F OKYAR, Dr.

Ferhat SIMSEK, MSc

Ali Fethi OKYAR, PhD

As the head and neck cancer (HNC) survival rate has increased and therefore, the focus of post-treatments is to improve the quality of patients' life by decreasing the side effects. Treatment of HNC leads to acute and chronic soft tissue damage, and functional loss. However, patients with HNC need having rehabilitation throughout the post-treatment phase so as to improve functional outcomes because of the long term side effects. Chronic shoulder morbidity is one of the complications after surgery due to spinal accesory nerve injury. Moreover, pain, dysphonia, and musculoskeletal impairments are observed in the individuals after the treatments and the patients also have trouble swallowing problems, loss of taste, dry mouth, trismus, nausea, vomiting, and fatigue during and after therapy. Since there is limited research on the usage of manual therapy techniques in HNC patients, this study aims to investigate muscle changes after surgery and the effectiveness of physiotherapy on muscle material behaviour from a biomechanical perspective by using shear wave elastography. In this respect, the hypothesis is:

H0: Physical therapy interventions do not impact mechanical properties of muscle, pain, quality of life, cervical and shoulder functionality in HNC patients after neck dissection.

H1: Physical therapy interventions will improve mechanical properties of muscle, pain, quality of life, cervical and shoulder functionality in HNC patients after neck dissection.

As the HNC survival rate has increased and therefore, the focus of post-treatments is to improve the quality of patients' life by decreasing the side effects. Treatment of HNC leads to acute and chronic soft tissue damage, and functional loss. However, patients with HNC need having rehabilitation throughout the post-treatment phase so as to improve functional outcomes because of the long term side effects. Chronic shoulder morbidity (70% of patients) is one of the common complications after surgery, whereas 84% of survivors complain of their physical appearance due to the remaining head and neck lymphedema (HNL) after radiotherapy. Moreover, pain, dysphonia, and musculoskeletal impairments are observed in the individuals after the treatments and the patients also have trouble swallowing problems, loss of taste, dry mouth, trismus, nausea, vomiting, and fatigue during and after therapy.

Materials might behave in different stress-strain relationships, and it is represented by a stress-strain curve, a basic descriptor of material.Thanks to the stress-strain diagram, differences between materials can be determined such as stiffness, hardness and toughness. Several concepts describe material properties in addition to a stress-strain diagram. For instance, a homogeneous material is one whose properties are not affected by location within the material, anisotropic material is one whose properties are free of direction, and incompressible material retains its volume during deformation. However, the behaviour of soft tissue is anisotropic due to its fibre contents, its constitutive behaviour is nonlinear and incompressible, and it is heterogeneous material owing to its composition, but it can be homogenized under macroscopic analysis. Due to the complexity of soft tissue, its mechanical behaviour is highly affected by density, collagen and elastin's structural arrangement, topographical site, function, and hydrated matrix of proteoglycans. In other words, mechanical properties of soft tissues are related to shape, genetics, age , physical and chemical environmental conditions like strain rate, osmotic pressure and Ph, temperature, which affects skeletal muscle's contractile properties.

It is known that deformable-body changes shape when it is exposed to an external force. In general, several constitutive relations govern the stress and strain relations, for example, plasticity, viscoelasticity, linear elastic, hyperelasticity so on. It is common to use hyperelastic models (i.e. time-independent) so as to determine the association of the stress-strain of soft tissue, even though the biological soft tissues mechanical behaviour is time-dependent . These models are based on the strain energy density which is the energy stored by a system undergoing deformation.

Disuse and immobilization influence muscle fibres harmfully including decreased muscle strength and neural activation of muscle fibre, muscle atrophy, loss of force production and endurance due to decrease in cross-sectional area (CSA). Jones et al., found that immobilization leads to muscle atrophy by decreasing protein synthesis and increasing protein impairment and loss of muscle mass after two weeks of immobilization. Muscle atrophy can exist in the following injury, during an illness such as cancer, sepsis and long term hospitalization. Shortening of myosin and actin filaments alters mechanical properties of muscle because of length-dependent force production. Moreover, the energy production of skeletal muscles is affected during the disuse period by decreasing fat oxidation and enhancing glycolysis, which is a source of muscle energy. Furthermore, muscle composition is impacted due to disuse and inactivity, mainly in type 1 fibre, which maintains postural control. Since radiotherapy and surgery impact negatively on muscle. For instance, after neck dissection, trapezius muscle atrophy seems to be due to SAN injury. It is found that atrophied trapezius muscle's stiffness was significantly lower because of physiological and intrinsic alterations associated with fatty infiltration and atrophy of muscle It is known that physical training affects muscle architecture, such as fibre type distribution, fascicle length, pennation angle and CSA, and force production. Since physical activity contributes to improving the CSA of skeletal muscle, muscle strength and bulk are increased. Moreover, exercise contributes to increased neural activity, contractile tissue and differentiating fibre type. Muscle mechanical properties may change.

Myofascial techniques are one of the manual therapy interventions which focus on treating fascia. It comprises various techniques and interventions such as acupuncture, dry needling, wet needling with pharmaceuticals, and traditional technical approaches such as strain-counter strain, muscle energy technique, positional release, ischemic compression and myofascial release (MFRT). The effectiveness of MFRT has been shown in various trials in different fields. For instance, MFRTs improve outcomes in individuals having shoulder pain, ankle joint restriction, fibromyalgia and lateral epicondylitis. On the other hand, in the cancer field, since MFRTs perform in addition to a standard rehabilitation program, the effect mechanism of MFRT is unclear in cancer . However, it impacts positively on pain, emotions and cancer-related fatigue.

As stated in the surgery part, inflammatory response leads to fibrosis due to increasing edema and healing proteins. This chronic tension that results in abuse, disuse, overuse and anxiety could cause fascial thickening. Within this regard, fascial work is one of the most important parts for treating fibrosis.

As mentioned before, patients with head and neck cancer suffer from the side effects of the treatment. One of the harmful effects of the treatments mostly causes neck and shoulder muscle atrophy, fibrosis and reduction in functionality level. Therefore, it is important to determine changes in mechanical properties of muscles so as to understand effectiveness of physical therapy interventions in HNC patients. To our knowledge, this study will be the first study to directly investigate how neck and shoulder muscles adapt to physical therapy interventions in the scope of material behaviour in HNC patients after neck dissection.

This study will be conducted in Yeditepe University Research Hospital/ Ear Nose and Throat Department.

A randomized single blind controlled clinical trial

Investigation of Effects of Physiotherapy Interventions on Mechanical Properties of Muscle in Head and Neck Cancer

Investigation of Effects of Physioherapy Interventions on Mechanical Properties of Muscle in Head and Neck Cancer

There is not a plan to make IPD available.

It will be measured by Shear Wave Elastography in relax and contracted state of muscle Muscles: M. Upper Trapezius, M. Sternocleidomastoid, M. Masseter /Bilateral

It will be measured by Shear Wave Elastography Muscles: M. Upper Trapezius, M. Sternocleidomastoid, M. Masseter /Bilateral

The Functional Assessment of Chronic Illness Therapy system of Quality of Life- Head and Neck (FACT H\&N Turkish Version)

Active range of motion will be measured by goniometer for both side

Gap between two incisor teeth with full opened mouth

Yeditepe University Hospital

Yeditepe University

PT, MSc

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Preoperative optimisation Supportive care LEAN in patient pathways

Preoperative preparation 2010

Lise Hounsgaard, ass. prof.

Background Denmark has a record-high incidence of, and mortality rate for, ovarian cancer. There are 600 new cases of ovarian cancer each year. In 2008 the state issued a guarantee of early diagnosis and treatment of all cases of suspected cancer, and surgical treatment has been centralised and standardised in fast track programmes. However, the investigators do not know how women with ovarian cancer experience the period prior to surgery and how they can optimally prepare for treatment and care.

Aim The two principal aims of the study are to describe health and coping in Danish women surgically treated for ovarian cancer; and to examine to what extent it is possible, from both a patient and professional perspective, to improve the health and everyday life of patients with ovarian cancer.

Materials and methods The study is conducted within the scientific theoretical framework of hermeneutics, involving the overall concepts of health promotion and rehabilitation. The study will be carried out in 4 stages between September 2008 and September 2011. Stage 1: A health-related characterisation of Danish women with ovarian cancer through a registration process. Stage 2: Qualitative research interviews with patients, to gain knowledge about spontaneous preoperative coping strategies and resources.

Stage 3: The preoperative preparation programme will be developed and clinically tested. The effect of participation will be measured by self-assessed health and coping before and after surgery. The study period runs from the time the decision is taken to operate until eight weeks after discharge. The study takes place at the Department of Gynaecology at Aarhus University Hospital, Skejby in Denmark, which is a regional centre of surgical treatment of gynaecological cancer.

Results The study provides insight into the preoperative coping strategies and general health of Danish women suffering from ovarian cancer. The development and testing of the preoperative preparation programme contributes to knowledge about optimisation of preoperative preparation. This might have a positive impact on the participants' general health and level of functioning during their treatment. Furthermore, the project contributes to knowledge of the preoperative coping strategies and experiences of (female) cancer patients in general.

Supervisors Lise Hounsgaard, Associate Professor, PhD, Research Unit of Nursing, Institute of Clinical Research, Faculty of Health Sciences, University of Southern Denmark. Lone Kjeld Petersen, Consultant, DMSc. and Jan Blaakær, Consultant, DMSc.Department of Gynaecology and Obstetrics Y, Aarhus University Hospital, Skejby.

Funding Faculty of Health Sciences, University of Southern Denmark. Department of Gynaecology and Obstetrics Y, Aarhus University Hospital, Skejby. The Research Foundation of Health Science in Central Denmark Region. The Research Foundation of Aarhus University Hospital, Skejby. The Hede Nielsen Foundation. The Danish Cancer Society, Psychosocial Research Committee. Tha Danish Nurses organisation

Health and Coping Prior to Ovarian Cancer Surgery

University of Southern Denmark

Aarhus University Hospital

Danish Cancer Society

University of Aarhus

Lene Seibæk

Digestive System Diseases

Stomach Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Patients over 18 years of age with esophageal or gastric cancer, who are living in Southern Sweden, and who are planned to undergo curative surgery treatment at Skåne University Hospital. n=100 (anticipated)

The historical control group consists of patients, living in Southern Sweden, who underwent esophageal or gastric cancer surgery between 2013 - 2021 at Skåne University Hospital. n=100 (anticipated)

The experimental group will receive structured individualized assessment based on physical, psychological or social needs and will be offered evidence-based interventions to promote rehabilitation and recovery.

evidence-based individualized rehabilitation

Wenche Melander, PhD-student

Marlene Malmström, PhD

This study aims to develop and evaluate a model for systematic and evidence-based cancer rehabilitation for people with esophageal and gastric cancer to provide conditions for a better quality of life and fewer cancer-related symptoms.

Sweden has had a National Cancer Rehabilitation Programme since 2014. This emphasises that all people with cancer have the right to individualised rehabilitation and that the contact nurse has an important role to play in identifying needs and ensuring evidence-based interventions throughout the cancer process to promote rehabilitation. The needs for optimised rehabilitation vary according to several parameters such as the person's personal circumstances and preferences, social support and type of cancer disease.

Despite this and a growing number evidence within this area cancer rehabilitation is often not integrated in clinical care. The current cancer care focuses on medical and treatment related interventions. It is a challenge for health services to find models to identify and meet the increased need for cancer rehabilitation in a systematic and structured way throughout the cancer process, based on the specific needs of each individual. This study aims to develop and evaluate a model for systematic and evidence-based cancer rehabilitation for people with esophageal and gastric cancer to provide conditions for a better quality of life and fewer cancer-related symptoms.

Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer

Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer - a Clinical Trial Evaluating and Implementing a Model for Evidence-based Cancer Rehabilitation

Demographic details will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer). There are no scales, only quality registry data.This data includes gender,cancerdiagnosis, tumourstage, comorbidity according to ASA, surgerydate, postoperative tumourstage.

Overall survival will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer). There are no scales, only quality registry data.

Incidence rate and severity of general complication according to Clavien-Dindo classification. Genereal complications will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer).

Incidence rate of change of level of care in the context of postoperative care will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer).

Length of stay at the hospital will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer). Will be measured in number of days.

The rate of re-admission up to 30 days postoperative will be collected via NREV (Swedish national quality registry for esophageal and gastric cancer).

Postoperative discharge destination (i.e if the patients goes home or to another care unit after discharge) will be collected via NREV (Swedish national quality registry for esophageal and gastric cancer)

The instrument QLQ-C30 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measures quality of life. The instrument has a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit 4=very much). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status/QoL scale, and six single items. All of the scales and single-item measures in score from 0-100. A high scale score represents a higher response level. A high score for functional scale represents a high/healthy level of functioning. A high score for global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.

The instrument QLQ-OG25 is developed by the EORTC and measures diagnose specific quality of life. The instrument hast a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scoring approach for this instrument is identical in principle to that used for the scales/items of the EORTC-QLQ-C30.

The INFO-26 instrument is developed by the EORTC and measures the patients perception of information received. The response format is a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) in all items except four which has a two point scale (Yes/No).

The instrument IPAQ will be used to measure physical activity trough 5 questions on level of physical activity and time spent on physical activity. The IPAQ short form asks about three specific types of activities which are assessed in walking, moderate-intensity activities and vigorous-intensity activities. The instrument provides separate scores (duration and frequency) on the three types of activity.

HADS will be used to measure the patients level of anxiety and depression. HADS is a 14-item scale with items for anxiety and depression subscales. Each item is rated on a 4-point Likert scale (ranging from 0=not at all, to 3=yes definitely) for a total score from 0-21 for each subscale. A higher score indicates higher levels of anxiety or depression.

ASC will be used to measure the patients worry about cancer and worry about health trough 5 questions ranging from 1-4. Higher scores indicates greater worry.

Connor-Davidsson Resilience Scale (CD-RISC) will be used to measure patients resilience trough 10 questions ranging from 0-4 Lower scores indicate more problems.

Assessment of rehabilitation needs will be used to measure patients rehabilitation needs. A 4 point Likert scale which ranges from "no problem" to "very troublesome problem" . Higher scores indicate more problems.

Psychological Distress is measured by the "Distress thermometer" and will be used to measure level of distress. A scale from 0 = no distress to 10 = high distress. Higher scores indicate greater distress.

Sickness abscens and to which extent the patient work will be measured by single items concerning this area.

Single item question concerning amount of hours physical activity per day.

Single item questions concerning alcohol use.

Single item questions concerning tobacco use.

Single item question concerning height in meters.

Single item question concerning weight in kilograms.

Weight and height will be combined to report BMI in kg/m\^2.

Dysphagia will be measured by a single item concerning how it works to swallow for the patient and it ranges from 0-4 (0=no dysphagia to 4=total dysphagia) Higher scores indicate more difficulties swallowing.

Questions about the rehabilitation process will be measured by single items concerning this area.

Karolinska Institutet

Region Skane

Associate professor

Fatigue

Therapeutic Exercise Program (standard care) will include:

1. Neck range of motion and strengthening, and posture retraining.
2. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function.

The Therapeutic Exercise Program (standard care) will include:

1. Neck range of motion and strengthening, and posture retraining.
2. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function.

The Resistance Exercise component will target 6-8 muscle groups of the lower extremities and core including gluteal, quadriceps, hamstrings, abdominals, and gastrocnemius muscles. A progressive introduction of exercises will occur over the first 3 weeks.

1. a personalized program of lower extremity resistance exercises
2. core strengthening exercises

A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.

Therapeutic Exercise

A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise

Therapeutic + Lower Body Exercise

Margaret L. McNeely, PhD

The investigators will conduct a randomized controlled trial examining 12-week, 24-week and one year outcomes from a combined therapeutic and physical exercise program that aims to bridge head-and-neck cancer survivors from acute care rehabilitation services to community-based exercise programming.

Participants will be stratified by early (within 18 months of surgery) and late (\> 18 months of surgery) and randomized on a one-on-one basis to (1) a supervised therapeutic exercise program for the neck and shoulder (serving as standard care) or (2) a combined therapeutic and lower body resistance exercise program. The randomization sequence will be generated by staff in the Rehabilitation Research Centre at Corbett Hall and placed in sealed opaque envelopes.

The exercise program will be offered in a group setting. Participants will exercise 2 times per week for a 10-week session and will have the option to continue for an additional 10-week maintenance session. The primary outcome for the study will be quality of life as measured by the Functional Assessment of Cancer Therapy (FACT)-Fatigue Scale at 12-weeks.

At each measurement point following the baseline assessment, including the 12-week and 24-week and one year follow-ups, an Independent Assessor will perform the objective fitness measurements. The Independent Assessor will also administer the Neck Dissection Impairment Questionnaire and the FACT-Fatigue quality of life questionnaires. The Physical Activity Adherence Diary will be collected by a Research Coordinator at each follow-up visit.

Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors

Evaluating Outcomes From a Combined Supervised Therapeutic and Physical Exercise Program for Post-surgical Head and Neck Cancer Survivors: A Randomized Controlled Trial

Godin Leisure Time Questionnaire: minutes of mild, moderate and strenuous exercise.

costs to programming, institution and participants

Adherence to exercise programming: attendance at supervised exercise sessions and self-directed sessions over the 1 year period.

Active and passive glenohumeral joint range of motion using standard 12 inch goniometer.

Derived from height and weight of the participant.

The maximal amount weight that can be pulled (seated row) and pushed (vertical bench) with proper form.

Measures of neck flexion, side flexion, rotations and extension using myrin goniometer.

Maximal repetitions to fatigue based on 50% of 1 repetition maximum strength for seated row.

Maximal grip strength: composite score of both hands. Best of three attempts for each side.

The maximal amount of weight that can be moved with proper

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Personalised Exercise Rehabilitation for Cancer Survivorship	NCT05615285	Cancer	PERCS Triage an...	18 Years -	University of Dublin, Trinity College
Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN)	NCT06405542	Chemotherapy-in...	EX-CIPN	18 Years -	University Health Network, Toronto
Investigation of Effects of Physiotherapy Interventions on Mechanical Properties of Muscle in Head and Neck Cancer	NCT05399953	Head and Neck C... Spinal Accessor... Thyroid Cancer Scapular Dyskin... Cervical Pain Shoulder Pain	Myofascial Rele... Exercise Scar Tissue Mas...	18 Years -	Yeditepe University
Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN)	NCT06405542	Chemotherapy-in...	EX-CIPN	18 Years -	University Health Network, Toronto
Health and Coping Prior to Ovarian Cancer Surgery	NCT01213771	Health and Copi... Cancer Rehabili...	Preoperative pr...	18 Years - 90 Years	University of Aarhus
Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer	NCT05698992	Esophageal Canc... Esophageal Neop... Gastric Cancer Stomach Neoplas...	evidence-based ...	18 Years -	Region Skane
Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors	NCT02647021	Head and Neck N... Accessory Nerve... Fatigue	Therapeutic Exe... Therapeutic + L...	18 Years -	University of Alberta
Muscle Stimulation for Physical Function During Stem Cell Transplant	NCT04364256	Autologous Hema...	RS-4i Plus Sequ...	18 Years -	VA Office of Research and Development
Rehabilitation for People With Advanced Cancer	NCT05424068	Advanced Breast... Advanced Colore... Cancer Rehabili...	In-person rehab... Virtual rehabil...	18 Years -	University Health Network, Toronto
Cancer Rehab Program for Allogenic Bone and Marrow Transplant Patients - CaRE-4-alloBMT	NCT04966156	Allogeneic Dise... Hematologic Can... Cancer Rehabili...	CaRE-4-alloBMT ...	18 Years -	University Health Network, Toronto
Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer	NCT05698992	Esophageal Canc... Esophageal Neop... Gastric Cancer Stomach Neoplas...	evidence-based ...	18 Years -	Region Skane
Manual Therapy and Use of the Dynasplint for Trismus in Patients With Head and Neck Cancer	NCT03178110	Neoplasms, Head... Trismus	Physical therap...	18 Years -	University of Alberta

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