Neoplasms

All Conditions

Behaviors and Mental Disorders

Head and Neck Neoplasms

Quality of Life

Oluwafunmilola T Okuyemi, MD

Jay F Piccirillo, MD, FACS

Cancer survivorship has dramatically improved within the last four decades and a greater number of Americans are living after cancer diagnosis. An increase in the number of survivors has highlighted the need to investigate the quality of life experienced by these survivors. While Survivorship research has improved our understanding of the challenges faced by some cancer survivors, there is a paucity of research on the functional and cognitive health status of head and neck cancer survivors.

The purpose of this study is to evaluate the functional and cognitive changes that occur in head and neck cancer patients as a result of cancer treatment, in an attempt to increase our understanding of the complex interactions between cancer treatment, comorbid health ailments and quality of life.

Cancer is the second leading cause of death in the United States today, accounting for nearly a quarter of total deaths. Due to advancements in cancer management, specifically in the areas of surveillance, early diagnosis, and utilization of evidenced-based therapies, there has been an increase in the number of survivors in the United States. As at 2007, there were over 11 million cancer survivors in the United States and this number is projected to reach 15 million by the end of 2010. Investigations into the quality of life experienced by these survivors have therefore become necessary if these survivors are to be effectively managed through their course of cancer.

The increase in the number of cancer survivors has opened up a relatively new avenue of cancer research termed Cancer Survivorship Research. Cancer Survivorship Research seeks to investigate the physical, functional and psychosocial consequences of cancer. Despite advances made in survivorship research, gaps remain in our knowledge concerning the ability of the cancer survivor to reintegrate into life and function at pre-cancer levels. These knowledge-gaps are especially true for head and neck cancer patients as demonstrated by the paucity of studies in the literature evaluating the functional and psychosocial consequences of cancer in this cohort. This is a significant short-coming especially since head and neck cancer patients are at increased risks for adverse consequences due to their advanced age at the time of cancer diagnosis, comorbidity burdens and substantial history of alcohol or tobacco use.

This study will evaluate the functional and cognitive changes that occur in head and neck cancer patients as a result of cancer treatment, in an attempt to understand the consequences of cancer treatment on the quality of life experienced by these survivors.

Our study will use self-report questionnaires, neurocognitive assessments and novel performance-based assessments to evaluate functional and cognitive health status at two time-points:

1. At Baseline (before any cancer treatment modality)
2. After the first stage of cancer therapy (chemotherapy, radiation or surgery)

Assessments to be utilized include the Center for Epidemiologic Studies Depression Scale (CES-D), University of Alabama Life Space Assessment Aids form (LSA Aids), Dysexecutive Questionnaire (DEX), Katz Index of Activities of Daily Living (ADLs), Lawton Index of Instrumental Activities of Daily Living (IADLs), University of Alabama Life Space Assessment (LSA), Short Blessed Test (SBT), Short Physical Performance Battery (SPPB), Adult Comorbidity Evaluation-27 (ACE-27), and the Delis Kaplan Executive Function Scale (DKEFS) - Sorting task, Color Word Interference task, and Trail Making task.

Participants will also be assessed using the Executive Function Performance Test (EFPT). The EFPT is a performance-based measure of cognitive function developed at the Program for Occupational Therapy at Washington University School of Medicine that assesses (under direct observation) the amount of assistance needed by participants to complete five basic tasks essential for self-maintenance and independent living. The tasks include hand-washing, cooking, using the telephone, taking medications and paying bills.

Head and Neck cancer patients will undergo these comprehensive assessments at each of the two time-points, allowing for the ability to follow changes in function and cognition over the course of cancer therapy. Statistical analyses will be performed with the SAS® software version 9.1.3 to obtain descriptive statistics and to investigate statistically-significant changes in functional and cognitive health status between the time-points evaluated.

Comprehensive Assessment of Head and Neck Cancer Survivors

A Comprehensive Assessment of Adult Head and Neck Cancer Survivors (A Pilot Study)

University of Alabama at Birmingham

Jay F. Piccirillo, MD

Professor, Washington University School of Medicine

Nutritional and Metabolic Diseases

Malnutrition

Nutrition Disorders

Matthias Pirlich, MD

Malnutrition is a common phenomenon in cancer patients. Deteriorated nutritional status is associated with poor clinical outcome. The purpose of this study is to determine the prevalence of hospital malnutrition and its impact on functionality, quality of life and mortality in cancer patients and to test the reference percentiles of phase angle values (Bosy Westphal et al JPEN 2006) as indicator of cancer cachexia and predictor of mortality.

Hypothesis:

The fifth reference percentile of the phase angle norm values is a prognostically relevant cut off value indicating cancer cachexia in terms of malnutrition, fatigue and impaired functional status, as well as predictive of 6-month mortality

Prevalence of Malnutrition in Oncologic Patients

Prevalence and Impact of Malnutrition in Hospitalised Patients

Phase angle (bioelectrical impedance analysis) Nutritional status(SGA), muscle function (grip strength)

Quality of life is determined with the questionnaire QLQ C-30 of the European Organisation for Research and Treatment of Cancer (EORTC)

Patients are going to be contacted via telephone six months after the first assessment. Deceased patients will be determined by the local death register

Risk for depression is assessed using the Center for Epidemiological Studies Depression Scale (CES-D)

Charite University, Berlin, Germany

Kristina Norman

Nervous System Diseases

Musculoskeletal Diseases

Rare Diseases

Glioblastoma

Brain Neoplasms

Muscular Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

12-week circuit-based resistance exercise

CRT is a common training method used to foster aerobic fitness, muscular endurance and strength, as well as neuromuscular adaptations in one workout. CRT is comprised of several sets of different exercises with little rest in between each set.

Circuit-based resistance exercise (CRT)

Scott Grandy, PhD

Mary MacNeil, MD

Glioblastoma patients are confronted with a debilitating disease associated with a low survival rate and poor quality of life. The goal of this study will be to reach a largely underrepresented population in the exercise literature and explore the role of a tailored circuit-based resistance training program on functional fitness (i.e., ability to carry out tasks of daily living) and associated health outcomes (e.g., quality of life) for GBM patients on active treatment.

PROBLEM: Glioblastoma multiforme (GBM) is the most common brain malignancy accounting for approximately 48% of all brain tumors. GBMs are highly vascular and can cause vasogenic brain edema and mass effect, which can worsen the neurologic symptoms associated with the disease. Corticosteroids (i.e., Dexamethasone; DEX) are the treatment of choice to reduce vasogenic edema and intercranial pressure associated with GBM. However, the use of steroids comes at a cost. High dose steroid therapy and/or long-term use results in muscle myopathy (i.e., muscle weakness) in 10-60% of GBM patients, significantly reducing functional ability as well as quality of life (QOL). Thus, adjuvant therapies are needed to help patients maintain their functional ability and QOL. There is a wealth of evidence to support the use of exercise as an adjuvant therapy to improve functional ability as well as help manage treatment-related symptoms. Resistance training (RT) has been shown to increase muscle mass, strength, and functional ability in aging adults and several cancer populations. While limited, studies in GBM have shown that exercise is safe and feasible for this population and that it can improve functional performance. However, no specific research has been performed to determine whether RT can be successfully used in GBM to prevent or reduce steroid induced muscle myopathy. Therefore, the primary purpose of this study is to establish whether an individualized circuit-based RT program will improve functional fitness for patients on active treatment and receiving steroids.

METHODS: This is a two-armed randomized control trial with repeated measures. Thirty-eight adult (18+ years) patients diagnosed with either primary or secondary GBM who are scheduled to receive standard radiation and concurrent adjuvant Temozolomide chemotherapy post-surgical debulking as well as received any dose of DEX will be recruited through the neuro-oncology clinic and the QEII Cancer Center. Patients will be randomly allocated to a standard of care group (SOC) or SOC+RT group (EX). Those in the SOC group will be advised to maintain an active lifestyle for the 12-week intervention whereas those in the EX group will receive a personalized 12-week circuit-based RT program. This program will consist of 3-4 supervised RT sessions/wk. During each session participants will perform a RT program that is comprised of 3 circuits. Each circuit will include 3 sets of 3 different exercises. Each exercise set will be 1 minute in duration (20 seconds/exercise) with 1 minute of rest between sets. Initial exercise intensity will be light and will increase throughout the program based on the participant's progress. All exercise programs will be designed and supervised by a Clinical Exercise Physiologist (CEP). The primary outcome measure for the study is functional performance which will be assessed using the Short Physical Performance Battery and hand grip strength. Secondary outcome measures will include body composition, aerobic fitness, physical activity levels, general health, QOL, fatigue, and cognitive function. All measures will be assessed pre/post-intervention. Safety and exercise adherence will be assessed throughout the study.

ANALYSIS: Descriptive statistics will be used to describe the population, accrual, program adherence and safety. Outcome data will be analyzed using an intention to treat approach. All participants will be entered into a mixed effects model with participant group assignment (EX, SOC) at randomization and timepoint (pre- and post-test) as fixed factors and participant entered as a random factor. Due to feasibility in recruiting participants in the allotted time, the study will not be fully powered to detect sex-based differences; however, effect sizes associated with the intervention will be calculated and presented separately for each sex.

SIGNIFICANCE: This study will demonstrate the not only is RT safe and feasible for those with GBM, but that it also significantly improves functional status by protecting against myopathy. This will help GBM patients maintain their independence which could lead to marked improvements in QOL.

RCTwith 1:1 allocation to intervention or wait-list control

The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors

The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors (RESIST)

Participant accrual calculated as % of patients referred divided by number of patients consented to participation

Participant attrition calculated as % of patients who complete 12-week study divided by number who withdraw from study

Participant program adherence calculated as % of exercise sessions completed divided by total number of available exercise sessions over 12-week intervention

Short Physical Performance Battery to assess activities of daily living

Weight (kg) and height (m) will be used to calculate BMI

Muscle mass and quality - 3T diagnostic magnetic resonance imaging

6 minute walk will be used to calculate aerobic fitness

Godin Leisure Time Physical Activity Questionnaire - Leisure Score Index will be used to calculate self-reported leisure physical activity

Functional Assessment of Cancer Therapy - Brain (FACT-Br) - 50 item scale; total scale score range 0-200; higher scores indicate higher overall QOL

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) - 13 item scale; score range 0-52; higher scores indicate less fatigue

Trail making test-b; Time taken to complete each task and number of errors made during each task are recorded and compared with normative data. Time to complete the task is recorded in seconds; the greater the number of seconds to complete the task, the greater the impairment.

Hopkins Verbal Learning Test-Revised for memory; total recall and recognition scores will be calculated

Mobility, self-care, usual activities, pain/discomfort, anxiety/depression (EuroQol-5Dimension-5Level; EQ-5D-5L) - 5 dimensions; higher scores indicate higher problems

EuroQol Visual Analog Scale 0-100; lower scores indicate worse health

Canadian Cancer Society (CCS)

Nova Scotia Health Authority

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Fatigue

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light (mild) physical activity program that begins approximately within one week after discharge from the hospital with the physical activity program starting approximately within the first week post-discharge from the hospital.

Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light (mild) physical activity program that begins approximately within one week after discharge from the hospital with the physical activity program starting approximately 7 weeks post-discharge from the hospital.

Conventional treatment for cancer as prescribed by the participant's health care providers and will participate in a supportive cancer-related education activity each week for 6-weeks after returning home from the hospital.

Light (mild) physical activity program that corresponds with normal every day activities of daily living (\< 3.0 metabolic equivalents, METs), with a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as you are able by week 6 as guided by your Registered Nurse researcher.

The program begins approximately within one week after discharge from the hospital with the physical activity program starting approximately within the first week post-discharge from the hospital.

Light Physical Activity 1

Light (mild) physical activity program that corresponds with normal every day activities of daily living (\< 3.0 metabolic equivalents, METs), with a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as you are able by week 6 as guided by your Registered Nurse researcher.

The program begins approximately within one week after discharge from the hospital with the physical activity program starting approximately 7 weeks post-discharge from the hospital.

Light Physical Activity 2

Participate in a supportive cancer-related education activity including a direct 10 - 15 minute phone conversation with a Registered Nurse researcher each week for 6-weeks after returning home from the hospital. Wear a pedometer each day of the study.

Recording pedometer steps in the daily diary each day.

Support Education Activity

Amy J Hoffman, PhD, RN

Karin Trujillo, MD

Amy J Hoffman, PhD

Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. This is a proposed randomized controlled trial of a novel rehabilitative intervention for persons with non-small cell lung cancer after surgery that promotes self-management of cancer-related fatigue (CRF) and is practical, portable, low cost, and safe. The results of the study will provide a novel exercise intervention, and its optimal timing, that helps a vulnerable population by reducing CRF severity and fatigability and is applicable to nearly all post-thoracotomy lung cancer patients.

Persons with non-small cell lung cancer (NSCLC) report significantly more unmet supportive care needs than other cancer populations, yet they are among the most vulnerable and least studied. Two of the most prevalent unmet supportive care needs include overcoming fatigue and attaining adequate exercise to meet physical demands of daily living. Cancer-related fatigue (CRF) is a prevalent, persistent, and distressing symptom in the NSCLC population. Cancer-related fatigue correlates with greater severity of 15 other symptoms, leading to lower physical function for persons with NSCLC. Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. While surgery is the standard curative treatment for NSCLC, no formal guidelines exist for post-surgical rehabilitation. This is a proposed randomized controlled trial (RCT) of a novel rehabilitative intervention for persons with NSCLC after surgery. The intervention promotes self-management of CRF and tests the intervention's impact on CRF severity and fatigability with analysis by age. Preliminary data included a two-arm RCT (R21 CA164515) incorporating the proposed intervention, where study goals were exceeded for recruitment (66%), retention (97%), adherence (93%), and acceptability. The 6-wk exercise intervention demonstrated preliminary efficacy in significantly reducing CRF severity and fatigability as compared to usual care, with mean CRF levels restored to levels lower than pre-surgery. The exercise group's functional performance exceeded usual care. No adverse events were reported; participants had a mean age of 67 with a mean of 8 comorbid conditions. The investigator's long-term goal is to develop interventions to increase perceived self-efficacy for CRF self-management in order to improve CRF, symptom status, functional status, and quality of life (QOL) for persons with NSCLC. The objective in this application is to determine the efficacy, optimal timing, and sustainability of this innovative home-based exercise intervention. This study has the potential to transform the current standard by providing a rehabilitative exercise intervention after surgery. The intervention is home-based, self-paced, and builds in duration upon discharge from the hospital after surgery. Aim 1: Determine efficacy by comparing the immediate intervention group with wait-list control (usual care) and attention control by age. Aim 2: Determine efficacy of initiating the exercise intervention 6 wks post-discharge and compare results with the immediate intervention group for all ages. Aim 3: Determine the immediate intervention's sustainability by analyzing 3a) rates of extension, adherence, and retention; 3b) acceptability; and 3c) efficacy of primary and secondary outcomes. IMPACT: The results of this study will provide a novel exercise intervention, and its optimal timing, and fill the gap for a vulnerable population by providing a practical, portable, and low-cost means of reducing CRF severity and fatigability that is enjoyable and applicable to nearly all post-thoracotomy lung cancer patients.

Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience

We will disseminate the results from this study at national/international meetings. We also expect that the findings of this study will be disseminated through scientific journals with multiple manuscripts prepared by the investigators from this study for publication in peer-reviewed journals. The investigators agree to continue to abide by the NIH Public Access Policy by submitting final peer-reviewed journal manuscripts to the digital archive, PubMed Central, upon acceptance for publication.

Degree of cancer-related fatigue severity on an 11-point scale (0-10, 10 = most severe)

Average fatigue level while performing the 6 minute walk test on an 11-point scale (0-10, 10 = most severe)

Severity of multiple symptoms and symptoms interference on daily life on an 11-point scale (0-10, 10 = most severe and most interference)

A persons's perception of ability to manage fatigue on an 11-point scale (0-10, 10 = very certain)

A person's perception to complete incremental 5-minute periods of walking using an 11-point scale (0-100%, 100% = very confident)

A person's perception of balance during every day activities using an 11-point scale (0-100%, 100% = very confident

Performance in average number of walking steps taken per day per week

Performance of daily mental and physical activities that people do in the normal course of their lives measured with eight subscales that focus on the physical and mental health components producing normative scores (0-100, 100 = higher functional status)

Satisfaction with various aspects of life and the importance of each aspect of life to the person using a 6 point-rating scale (1-6, 6 = very satisfied and very important)

Spectrum Health Hospitals

National Cancer Institute (NCI)

The Methodist Hospital Research Institute

University of Nebraska

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Konstantinos G Toutouzas, MD PhD

Several patients that suffer from gastrointestinal (GI) cancer are characterized by malnutrition and impairment of their functional status. The aim of the present study is to evaluate the nutritional condition of patients undergoing surgery due to GI cancer and compare it with their functional status. All consecutive patients with esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer, that underwent a surgical operation will be included. Demographic characteristics, nutritional assessment and anthropometric measurements of the patients will be recorded.

Nutritional and Functional Assessment of Patients Undergoing Surgery Due to Gastrointestinal Cancer (NUFAGI).

Nutritional and Functional Assessment of Patients Undergoing Surgery Due to Gastrointestinal Cancer (NUFAGI): a Prospective Cohort Study.

Maximos Frountzas

Study Coordinator

Skin and Connective Tissue Diseases

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

Subjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires.

Patient-reported outcome survey will be offered at baseline.

General health survey questionnaires

PROMIS Cancer Function Brief 3D profile questionnaires

FACT-G questionnaires

Godin Leisure-Time Exercise Questionnaire

REAP-S questionnaires

Sasha Knowlton, MD

The purpose of this single-site non-randomized study is to identify areas of need related to functional status and overall health, including nutrition and mental health in subjects with metastatic breast cancer (MBC). A decline in functional status is observed after breast cancer diagnosis and exacerbated by treatment. Declining functional status impacts the quality of life and can lead to increased comorbidity burden, hospitalization, and increased mortality. Functional status is assessed by specific provider-graded scales. Patient Reported Outcome (PRO) measures may better assess certain aspects of patient health and symptom domains. Thus, potentially supporting the future implementation of effective prehabilitation strategies. This study explores whether a PRO-based survey will identify the physical and emotional health and the social and financial status of patients newly diagnosed with MBC.

Assessing Functional Status Needs Via PRO Measures for Pts With Metastatic Breast Cancer

Assessing Functional Status Needs Via Patient-Reported Outcomes Measures in the Pre-treatment Setting With Metastatic Breast Cancer Patients

Physical activity levels will be measured using the Godin Leisure-Time Exercise Questionnaire. Godin Leisure-Time Exercise Questionnaire has 3 dichotomous questions, answers will be "yes" or "no". There will be reason questions if the answer is no.

Acceptability of survey to subjects will be measured by the percentage of eligible patients who complete the survey.

Health-related quality of life will be measured by Functional Assessment of Cancer Therapy (FACT-G) which is a survey assessing physical, emotional, and functional well-being on a Likert-type scale. higher scores demonstrating higher health-related quality of life, from 0 to 4. Higher scores represent better QOL.

The patient-Reported Outcomes Measurement Information System (PROMIS) survey will assess physical function, fatigue, and social participation. This survey was designed for cancer rehabilitation needs. It asks patients on a Likert-type scale about their ability to perform mobility and activities of daily living tasks along with the frequency of fatigue and ability to participate in vocational and avocational activities.

The diet quality will be measured using a modified version of the Rapid Eating Assessment for Participants (REAP-S) survey will assess diet and nutrition quality. For the general population, a score of 32 or higher determines a high-quality/desirable diet. The survey asks about the intake of nutrients including vegetables/fruit, whole grains, types of fat, calcium-rich foods, and others. Responses usually/often receive 1 point, sometimes receive 2 points, and rarely/do not apply to receive 3 points.

the percentage of subjects referred will be defined as subjects who have been referred to or used Lineberger Comprehensive Cancer Center supportive services for patients Referral rates will be reported for an array of the University of North Carolina Lineberger supportive services by questionnaire.

Barriers to accessing exercise will be evaluated by questionnaire.

Health-related opinions regarding prehabilitation interventions will be assessed by questionnaire which includes open-ended questions.

UNC Lineberger Comprehensive Cancer Center

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

In the control arm, patients are followed-up by the head-and-neck physician, oncologist and radiotherapists and did not benefit of Comprehensive Geriatric Assessment.

The CGA (Comprehensive Geriatric Assessment) is a multidimensional assessment of general health status, using validated scales. It produces an inventory of problems which can then serve to develop an individualized geriatric intervention plan of care and follow-up.

The CGA is a multidimensional assessment of general health status, using validated scales. It produces an inventory of problems which can then serve to develop an individualized geriatric intervention plan of care and follow-up

CGA and geriatric follow-up

Eléna Paillaud, MD / PhD

Lydia Brugel, MD / PhD

The intervention tested in this research project aims to reduce this inequality by improving the management of elderly head and neck cancer patients with a specific management. Indeed, the treatment of elderly head and neck cancer patients has specificities concerning treatment options, their tolerance, psychological management, nutritional and functional status, and support needed at home. To assess the overall needs of the elderly patients, an assessment known as "comprehensive geriatric assessment" (CGA) can be performed by a geriatrician with extensive testing and questionnaires. This assessment is long and requires an experienced geriatrician. It leads to the development of an individualized treatment plan (physiotherapy, psychological follow-up, support at home, nutritional management ...) and follow-up to adapt the necessary cares for the duration of the cancer treatment. The CGA utility has been studied in elderly patients with nonmalignant diseases. Studies have shown that CGA allowed improving survival and maintaining the elderly at home.

Context: The survival of elderly patients with head and neck squamous cell carcinomas (HNSCC) cancer is greatly reduced compared to younger subjects. Several explanations have been proposed : a competitive comorbidity, a more frequent refusal of standard therapy or the choice of a suboptimal treatment due to fear of toxicities. The comprehensive geriatric assessment (CGA) may influence the decision-making process and help for managing elderly patients with head and neck cancer. The CGA is a multidimensional assessment of general health status, using validated scales. It produces an inventory of problems which can then serve to develop an individualized geriatric intervention plan of care and follow-up.

Hypotheses: We postulate that the CGA and the geriatric follow-up improves 1) the therapeutic decision-making process thanks to a better assessment of the patient's functional reserve and its capacity to support or not the treatment, and 2) the overall survival, the functional status and the nutritional status of elderly patients with HNSCC because of a more appropriate treatment and a personalized medical follow-up after surgery and/or radiotherapy and/or chemotherapy or more rarely targeted therapy, with adjustment of treatments and management of comorbidities and/or treatment complications.

Main objective: To assess the impact of the CGA and the geriatric follow-up on the overall survival, the functional status and the nutritional status of elderly patients with HNSCC.

Secondary objectives: To assess the impact of the CGA on the therapeutic decision, the toxicity and/or complications of treatment, the complete realization of treatment, the autonomy, the institutionalization, the total hospitalization stay, the quality of life of elderly patients with HNSCCs and the costs.

Comprehensive Geriatric Assessment and Head and Neck Elderly Cancer Patients

Impact of Comprehensive Geriatric Assessment on Malnutrition, Functional Status and Survival in Elderly Patients With Head and Neck Squamous Cell Carcinomas (HNSCCs): a Randomized Controlled Multicenter Clinical Trial

Cancéropole Ile De France

Assistance Publique - Hôpitaux de Paris

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Participants allocated to the intervention group will be seen in the geriatric oncology clinic where they will be assessed using a geriatric assessment. Based on the issues identified in the geriatric assessment, a care plan will be developed with the participant to address the issues.

Participants randomized to standard oncology care will receive usual care from their oncology team.

The intervention will consist of a Geriatric Assessment conducted by a multidisciplinary geriatric oncology team followed by an integrated care plan developed and implemented by the team for those issues identified in the assessment. The study intervention includes contact with the intervention team at 4 points in time during the study: at baseline (to conduct the assessment and develop the integrated care plan), 2-3 weeks by telephone after the clinic visit to evaluate if the plan needs adjustments, at 3 and 6 months (to evaluate the outcomes of the integrated care plan; i.e., did the patient follow all recommendations of the integrated care plan and did the plan lead to the desired outcomes for the problems identified?

GA and Integrated Care Plan

Shabbir Alibhai, MD

Martine Puts, PhD

The purpose of this study is to determine the feasibility of implementing a randomized controlled study of the intervention (Geriatric Assessment followed by an integrated care plan carried out by the multidisciplinary geriatric oncology team) designed to maintain/improve quality of life and functional status in older adults with advanced gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.

Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer treatment decision of the cancer specialist.

Introduction: A comprehensive geriatric assessment (CGA) can identify functional and psychosocial issues in older cancer patients, which in turn can inform interventions to prevent/postpone adverse outcomes and maintain/improve the functional status and well-being of this population. However, few randomized controlled trials (RCTs) have been completed showing the evidence.

OBJECTIVE - To explore the feasibility and impact of a CGA followed by an integrated care plan on quality of life and functional status for older adults with advanced breast, gastrointestinal or genitourinary cancer METHODS -

A two-group parallel single-blind phase II RCT is enrolling 60 patients aged 70 or above, diagnosed with cancer, and starting first line chemotherapy at Princess Margaret Cancer Centre in Toronto. The randomization using sealed opaque envelopes is stratified by treatment intent (adjuvant versus palliative). The intervention entails a comprehensive CGA by a multidisciplinary geriatric oncology team followed by an integrated care plan to address any issues identified. Participants in the intervention group are seen at baseline for the CGA and for initiation of the integrated care plan, and again at 3 and 6 months to assess intervention fidelity and measure outcomes. The co-primary outcomes are: 1) maintaining/improvement in quality of life; 2) refining of cancer treatment plan. The secondary outcomes include: 1) Functional status; 2) feasibility of the study by tumor site.

Recruitment has been completed November 2015

A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients

A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients (A GEM Study for Older Cancer Patients)

We will measure quality of life with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core version 30 items (EORTC QLQ C30)

The treating oncologist will be asked to indicate the cancer treatment plan prior to receiving the geriatric assessment results using a survey previously used in the study of Dr. Alibhai et al (Am J Clin Oncol. 2012 Aug;35(4):322-8.).

After the GA the results will be send to the treating oncologist and after the physician will be asked to indicate whether or not and if yes how he/she modified the treatment plan based on the GA results

We will measure functional status with the Older American Resources and Services Instrumental Activities of Daily Living questionnaire (7 items)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comprehensive Assessment of Head and Neck Cancer Survivors	NCT01222481	Head and Neck C...		40 Years -	Washington University School of Medicine
Prevalence of Malnutrition in Oncologic Patients	NCT01120483	Cancer Malnutrition		18 Years -	Charite University, Berlin, Germany
The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors	NCT05116137	Glioblastoma Mu... Brain Cancer	Circuit-based r...	18 Years -	Nova Scotia Health Authority
Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience	NCT03724331	Fatigue Self Efficacy Quality of Life Physical Activi... Lung Cancer Non-Small Cell ...	Light Physical ... Light Physical ... Support Educati...	18 Years -	University of Nebraska
Prevalence of Malnutrition in Oncologic Patients	NCT01120483	Cancer Malnutrition		18 Years -	Charite University, Berlin, Germany
Nutritional and Functional Assessment of Patients Undergoing Surgery Due to Gastrointestinal Cancer (NUFAGI).	NCT05795374	Gastrointestina...		18 Years - 99 Years	National and Kapodistrian University of Athens
Assessing Functional Status Needs Via PRO Measures for Pts With Metastatic Breast Cancer	NCT05755347	Breast Cancer Metastasis	General health ... PROMIS Cancer F... FACT-G question... Godin Leisure-T... REAP-S question...	18 Years -	UNC Lineberger Comprehensive Cancer Center
Comprehensive Assessment of Head and Neck Cancer Survivors	NCT01222481	Head and Neck C...		40 Years -	Washington University School of Medicine
Comprehensive Geriatric Assessment and Head and Neck Elderly Cancer Patients	NCT02025062	Head and Neck S...	CGA and geriatr...	65 Years -	Assistance Publique - Hôpitaux de Paris
A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients	NCT02222259	Breast Cancer Gastrointestina... Genitourinary C...	GA and Integrat...	70 Years -	University of Toronto

Spots Global Cancer Trial Database for functional status