Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Behaviors and Mental Disorders

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Quality of Life

Acute Graft Versus Host Disease

Patients in the control arm will receive standard of care and no intervention.

Patients in the intervention arm will receive the PACT intervention provided by a multidisciplinary team of RNs, OTs, and PTs.

Using the Adaptive Leadership Framework for Chronic Illness as a guide. The nurse, occupational and physical therapists will meet with the patient and caregiver after the baseline assessment to discuss their Specific, Measurable, Achievable, Relevant, and Time-Bound (SMART) goals. Additionally, the occupational and physical therapists will provide the patient a PACT intervention binder. Regular phone calls or visits from a registered nurse, occupational therapists, and physical therapists for patients and caregivers in the intervention.

Palliative And supportive Care inTervention (PACT)

Ashley Bryant, PhD, RN

This single institution feasibility and acceptability study includes patients with acute leukemia which is designed to examine a novel palliative and supportive care intervention (Palliative and supportive Care inTervention; PACT) in which registered nurses (RNs), occupational therapists (OTs), and physical therapists (PTs) address the activity needs of older adults with acute leukemia during their hospital stay.

The primary objective of the study is to assess feasibility, acceptability, and change in pre and post measures of symptoms, function, and QOL by administering the PACT intervention. The first 20 participants in the control group will receive usual care. The next 20 participants will receive the PACT intervention. Each participant in the intervention group will be cared by a collaborative, multidisciplinary, integrated team including RNs, OTs and PTs.

This is a feasibility study. This study is conducted on one unit and to reduce bias and contamination, the control patients will be recruited and consented first. After recruitment of the 20 control patients, we will then recruit 20 intervention patients.

RN-Led Palliative and Supportive Care Intervention

Feasibility and Acceptability of A RN-Led Palliative and Supportive Care Intervention for Adults With Acute Leukemia

19 items include diarrhea, chills, heartburn, nausea, appetite, mouth sores, vomiting, constipation, cough, rash, shortness of breath, fatigue, anxiety, sadness, nothing will cheer me up, pain, insomnia, concentration, and memory. The severity is assessed from "None" to "Very severe" and the interference level is assessed from "Not at all" to "Very much."

Including five functional scales, three symptom scales, one global quality of life scale, and six symptom items. The score ranges from 0-100, higher score indicates better function and greater symptom burden.

Score ranges from 14-70. Higher score indicates higher perceived possibility to perform activity.

Score ranges from 0-100. Higher score indicates better quality of transition.

Score ranges from 0-100. The recommended cut-off score will be used to interpret the meaning of the score.

Guide discharge planning; guides resource utilization; provides insight; patient mobility. A standardized t-score will be generated.

Assess the independence, safety, and adequacy of washing hands

Identify use or not use health care service, then report the use of health care service, the service type, the reason of using health care service using open ended questions

Classify participants' functional impairment. Score ranges from 0-100. Higher score indicates better function level.

Patient balance and fall risk will be observed during the assessment. Time in seconds will be recorded.

Score ranges from 0-56. Lower score indicates higher fall risk.

Three trials will be performed on both right and left hands at each assessment. Average grip strength will be generated. Dominant hand will be documented.

Score ranges from 0-32. Higher score indicates higher level of preparedness.

Score ranges from 0-68. Higher score indicates lower symptom burden

Drawing the clock based on the instruction

Score ranges from 0-30. Score of 26 or above is considered as normal cognition.

Average performance score and satisfaction score are calculated

Record the number of times the patient stands in 30 seconds

Generate a standardized T-score. Higher score indicates worse health and higher symptom burden

Generate a standardized T-score. Higher score indicates better self-report well-being

The questionnaire consists of 4 domains, including perceived cognitive impairments, comments from others, perceived cognitive abilities, and impact of quality of life. The higher the score, the better the cognitive function.

National Institute of Nursing Research (NINR)

UNC Lineberger Comprehensive Cancer Center

Head and Neck Neoplasms

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

All Drugs and Chemicals

Androgens

Individuals age 65 or older receiving chemotherapy for cancer or short term androgen deprivation therapy for individuals 65 or older with prostate cancer.

Dittus Kim, MD

The proposed project will document the degree of function decline, assess the relationship between function and cancer- related symptoms and evaluate relationships between function and quality of life. Participants are evaluated before therapy, after therapy and again 3 months post therapy to evaluate functional change. Knowledge gained will help us plan interventions around the time of cancer therapy to help older adults preserve or improve function.

The study looks at functional change of elderly cancer patients. Approximately 52 cancer patients age 65 or older will be asked to participate. Cancer patients asked to participate will be receiving cancer therapy with the intention of providing a cure. Functional change will be assessed from the time of diagnosis, through therapy to the early post therapy time frame. A comprehensive model explaining reasons for function change is used as the framework for choosing variables to measure. Components of function that will be measured include a 6 minute walk test, lower extremity muscle strength, a Short Physical Performance Battery assessing function of legs and a test that simulates typical household activities. Surveys will be used to subjects own assessment of their activity and function. The four most common cancer-related side effects will be measured and include fatigue, sleep impairment, shortness of breath and pain. Some markers in the blood may be abnormal and be related to declines in function. They will also be measured. Differences in function over time will be determined and relationships between function, cancer-related side effects and quality of life will be assessed.

Serum samples will be obtained and stored at -80 degrees celsius

Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change

University of Vermont

MD, PhD, Assistant Professor

Symptoms and General Pathology

Fatigue

Prescribed exercises by Physical Therapy Problem-Solving Sessions to resume activities that ther person needs to do, wants to do or is expected to do.

Four online educational modules: What is Cancer-Related Fatigue? Nutrition, Sleep Hygiene and Exercise

Exercises completed, and rate of perceived exertion (RPE) will be reviewed during \& after each exercise session. Exercises will be modified by either increasing or decreasing the intensity. Decisions will be made based RPE, physical symptoms \& any identified barriers or supports. Weeks 1, 3, 5, \& 7, Cancer-related fatigue (CRF) education will be assigned. During weeks 2, 4, 6, \& 8, CRF education will be reviewed and a plan for how to apply the information will be developed. Participant will be guided through 6 steps of problem solving to address one occupational performance problem identified by participant within Canadian Occupational Performance Measure. Goal \& action plan for the week will be shared with the participant electronically. At the beginning of each session, participant will describe progress on previous week action plan. Based on participant's response, either a new goal will be developed or the current one modified..

Rehabilitation

Anne Fleischer, Ph.D

Many individuals who have had cancer experience functional limitations during and after their treatments. The most common side effect from cancer treatment that restricts cancer survivors' completion of daily activities is cancer-related fatigue. Here, we propose to investigate whether an interprofessional approach that targets physiologic, psychologic, and ecological factors will minimize cancer-related fatigue and enhance daily life participation for volunteer cancer survivors living in the community. The interprofessional team will include occupational therapy professor and students from Eastern Kentucky University (EKU), physical therapy and dietitian professors and their students from the University of Dayton, and instructional design instructor from EKU. The approach will include (1) individualized exercise programs-via physical therapy; (2) problem-solving strategies including modifying the environment or activity -via occupational therapy; (3) goal development via physical and occupational therapy; and (4) cancer-related fatigue education via instructional design. We hypothesize that this approach will result in participants experiencing less fatigue, increasing their mobility, improving their quality of life, and being more satisfied with how they perform daily activities.

Setting: Virtual environment

1. Evaluation and weekly meetings will be provided through Zoom® conferencing system provided by EKU or University of Dayton.
2. Educational and Exercise Videos will be accessed within an individual webpage for each participant within the study's website.

Research Design Pre-test/Post-test quasi-experimental design without a control group. This research design will allow us to assess if there is a change in the level of fatigue, mobility, quality of life, and/or perceived performance and satisfaction of important activities Screening Individuals who are interested in participating will contact the Occupational Therapy professor--principal investigator (PI) or Physical Therapy professor-collaborator (CL). PI or CL will contact the potential participant either by telephone or email. Within this initial communication, the potential participant will be provided with the following information: time commitment, type of evaluations, and intervention. If the participant continues to be interested, an electronic inclusion criteria screen will be sent. If all inclusion criteria are met, PI or CL will ask the participant for their physician contact information so a medical release form can be sent to them.

Physician medical release A release form will be faxed, sent electronically, or mailed to participant's oncology or primary care provider. Once this signed release is received, we will send an electronic version of the informed consent to the potential participant and schedule a time to review it and a tentative time for the initial evaluation.

Initial, Weekly, 4-week, and 8-week Standard of Care Cancer Survivor Evaluations Initial Evaluations After the participant agrees to take part in the study and signs the informed consent, the initial evaluation including questionnaires and physical therapy and occupational therapy assessments within one to two visits will be administered by physical therapy and occupational therapy students (PTSI and OTSI). Assessments will be recorded and reviewed by the supervising therapy professor to ensure assessments are performed using standardized methods. After the assessment eight weekly meetings will be schedule.

* Estimated length of weekly meeting is 20-30 minutes.
* Each exercise session is 30-45 minutes in length depending on which level of exercise the participant is completing. The participant will complete 3 sessions each week.
* Each participant will be provided their own webpage, which can only be accessed by them and the researchers. Within the webpage, the researchers will store the prescribed exercise program, including handouts, video and exercise log, and the problem-solving session goals and action plans. Links to the Cancer-Related Fatigue (CRF) educational modules, as they are assigned to the participant will be posted as well.

Online Cancer-Related Fatigue Management

Only researchers involved in this study, who have been approved by the Institutional Review Board, will have access to the data.

The investigator will calculate the participant's maximum heart rate using the formula 207-.70(age)= maximum heart rate. The prescribed exercise intensity will be based on this calculation. The investigator will then instruct the participant on how to measure their heart rate to monitor their exercise intensity during exercise.

This 9-item scale assesses the severity and interference of fatigue on a 0 (no fatigue) to 10 (greatest fatigue) scale

a semi-structured interview to understand the routine activities that the participant completes daily, specifically their self-care, leisure, and social activities. The participant rates the importance of each of the activities using a 0 to 10 scale. Zero indicates "no importance" and 10 indicates "very important." Then the participant rates their perception of how well they currently perform each of the important activities and how satisfied they are with their performance using a 0 to 10 scale. Zero indicates that "they are not able to perform" or "they are not satisfied" and 10 indicates that "they are able to perform the activity well" or "they are very satisfied." This is repeated for how satisficed with how they currently perform each important activity.

Participants answer the following question: "How would you rate your fatigue on a scale of 0 to10 with 0 being 'no fatigue' and 10 being the 'worst possible fatigue'

This 40-item 5-point Likert scale evaluates quality of life in individuals with fatigue as measured in 5 domains: physical, social/family, emotional, functional well-being, and fatigue. Higher scores reflect greater quality of life

Participants will complete a 6-minute walk at their chosen pace, using assistive devices if needed and with permitted standing rest breaks. Participants will be required to measure the length of a hallway, sidewalk, or driveway where they will be walking. They will then walk for 6 minutes. Participants will report the distance walked as well as the number of rest breaks taken during the 6 minutes.

Participants are seated in a standard height fixed chair without armrests, which is placed against a wall. They will move from sitting to standing and back to sitting position, with arms crossed against chest. The number of complete stands and sits (1 repetition) will be counted by the investigator and the participant within 30 seconds

This scale allows participants to rate their perceived exertion during physical activity. Patients will be instructed to rate their level of exertion during their home exercise program and at the conclusion of each session. This will be recorded on their weekly exercise log.

University of Dayton

Eastern Kentucky University

Professor

This group will be contacted to make an appointment for outpatient Occupational and Physical therapy. The therapist will determine the type, frequency and length of treatment. Follow up phone calls will be made to ensure appointments are made, kept and rescheduled as needed.

Patients randomized to this arm will receive contact information and a brochure outlining the services available within the supportive care program. The study coordinator will provide the information based on their results and assist the patient with contacting the program if desired.

OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.

Occupational and Physical Therapy

Mackenzi Pergolotti, PhD

The CARE Program is a randomized trial of a cancer rehabilitation program designed to help older cancer patients who have shown to have a loss of function.

This is a prospective, two-arm, single-center randomized controlled pilot trial of a cancer rehabilitation program for older adults, titled the 'CARE program,' which is designed to maintain and/or improve functional status and quality of life in older adults diagnosed with cancer. Adults aged 65 years and older with cancer will be screened with a Geriatric Assessment (GA) for eligibility. Although breast cancer patients will be eligible, this study will focus primarily on other types of cancers. Adults with at least one functional deficit --defined as impairment in ability to perform activities of daily living or instrumental activities of daily living, cognitive decline or balance -- will be randomized to either the intervention (CARE program) or to the control arm (Supportive care services information only). Both arms will receive a brochure about the supportive care program to provide patients who we've identified as having deficits with information about auxiliary services available and because the intent is to limit the difference between the groups. We hypothesize that patients who participate in the CARE program will maintain or improve functional status and quality of life when compared to supportive care services information only.

The CARE Program: CAncer REhabilitation Pilot Study for Older Adults

LCCC 1409: The CARE Program: CAncer REhabilitation Pilot Study for Older Adults

Compare the change in NEADL scores from baseline to 3 months between patients who receive the CARE program (intervention) and those in the control arm.

As measured by the Possibilities for Activity Scale (PActS)

As measured by the Blessed Memory Orientation Concentration test

To describe the feasibility of the CARE program by reporting enrollment and retention as defined by (1) percent eligible who agree to participate (2) percent in each group that completed follow-up measures at 2 and 3 months and (3) percent of patients in CARE program who go to 70% of appointments.

Intervention Group Only: As measured by the Berg Balance Scale

Intervention Group Only: As measured by the Disability of the Arm, Shoulder and Hand scale

Intervention Group Only: As measured by the Montreal Cognitive Assessment

Intervention Group Only: As measured by the Dynamic Gait Index

To evaluate the program a short interview will be completed with CARE team to determine what worked well, what didn't and suggested changes/improvements for CARE program after completion of project.

Neoplasm Metastasis

Participants instructed in individualized Rapid Easy Strength Training and pedometer-based walking programs

Participants instructed in REST after completing week 8 outcome measures

Instruction in an individualized rapid easy strength training (isotonic with therabands) and pedometer-based walking programs.

REST

The purpose of this study is to determine whether a gentle physical conditioning program comprised of isotonic resistive strengthening and pedometer-directed walking can improve the physical functioning and fatigue of patients with late stage lung or colon cancer.

A. SPECIFIC AIMS

The results of this prospective pilot cohort study will be used to power and inform the design of a randomized controlled trial. Its specific aims are:

1. To characterize the receptivity of patients with late stage lung or colon cancer to perform an individualized fitness program to prevent deconditioning and functional decline.
2. To estimate the adherence of patients with LSC (LSC) to an individualized fitness program.

4. To estimate the degree to which symptoms, e.g. fatigue and pain, associate with adherence to an individualized fitness program.

5. To estimate improvements in functional status associated with performance of an individualized fitness program among patients with LSC.

B. BACKGROUND AND SIGNIFICANCE Most people with LSC function poorly at diagnosis, deteriorate steadily over a period of months to years, and become dependent prior to death. Their disablement exacts staggering costs in quality of life (QoL), caregiver burden, and health care expenses. Oncologic clinicians, as a result of their training and focus on the treatment of cancer, often neither systematically detect nor treat the function and symptom problems that cause disablement. As a consequence rehabilitation therapies, even those with well documented evidence of benefit, tend to be under-utilized and provided too late to be maximally effective. The public health burden of this issue is likely to only worsen given the improving survival of patients with LSC and the increasing age and medical complexity of those being treated.

C. STUDY DESIGN AND METHODS Design A randomized controlled trial. Duration Following enrollment, study participants will remain on the study for 2.5 months after instruction in their individualized REST program. REST titration and tailoring for participant specific barriers will occur over the telephone for the 2 week "initiation phase" after initial REST instruction. Thereafter, patients will perform their REST independently at home during the 8 week "training phase" with "as needed" telephone-based guidance from a PT. We therefore anticipate that the study will continue for a total of 6 months; 3 months to recruit 68 patients and an additional 2.5 months for all participants to complete initiation and training phases of the protocol.

Subject Enrollment Identification of participants. A sample of 68 patients with Stage III or IV NSCLC or Extensive stage SCLC, or Stage IV colon cancer will be identified.

Dr. Cheville will contact eligible patients by telephone after they receive a mailing describing the study and permitting them to opt out by returning a postage-paid postcard. A 'fold over' postcard will be sent so as to maintain the patient's privacy regarding lung or colon cancer diagnosis. Dr. Cheville's efforts to contact eligible patients will continue until 5 attempts have been made on different week days and times of day. Eligibility and inclusion and exclusion criteria will be assessed. If the patient is eligible, the study will be described in detail and verbal consent will be obtained from those desiring to participate. An informed consent form will be mailed to each patient willing to participate in the study to ensure that they have adequate opportunity to review the document. Informed consent will be obtained by Dr. Cheville when the patient comes to the Mayo Clinic for study enrollment. All questions will be answered prior obtaining informed consent.

Eligibility. Eligible subjects must have a diagnosis of Stage III or IV NSCLC or extensive stage SCLC, or Stage IV colon cancer and be receiving a chemotherapeutic regimen that requires visits to the Mayo Clinic Department of Medical Oncology \< every 4 weeks for the first 6 weeks following enrollment or undergoing monitoring visits at comparable intervals. Pathological confirmation is not required if the oncology provider specializing in lung cancer has a high level of certainty regarding the diagnosis. Entry criteria will not consider number or location of metastases or prior treatment. The participants will be required to be fluent in the English language and have intact cognitive status (Folstein mini-mental score \> 25).

Recruitment. Approximately 50 new lung cancer cases are diagnosed each month at the Mayo Clinic. Of these, about 70% are initially diagnosed with Stage III or Stage IV NSCLC or Extensive Stage SCLC and 60% elect to receive their cancer-related care at Mayo. Recruitment rates in our previous work in this population have been high. The proposed intervention entails greater patient commitment and we anticipate a recruitment rate of 50%. We will target patients meeting the study criteria who are undergoing ongoing treatment at the MCCC as well as those who are newly diagnosed. We anticipate a recruitment rate of 10 patients per month and that recruitment will continue for 3 months. We have not previously recruited patients with colon cancer, but anticipate recruitment of 10 patients per month based on the experience of other researchers.

Randomization. Patients will be block randomized to the REST intervention or wait-list control. Stratified randomization will not be used.

Intervention Overview. The intervention is provision of an individualized, 2-part, 3-tiered REST program which will include the exercises listed in Table 1 to all participants randomly assigned to the intervention arm. In addition, participants will receive a step pedometer and will be encouraged to remain as active as possible during the study period based on objective feedback from their pedometer readings. A PT specialized in cancer rehabilitation will instruct participants in REST and will adapt the program to accommodate for symptoms, co-morbidities, or other issues that may impede a participant's ability to perform the REST program. The PT will follow up with each participant by telephone at 1- and 2-weeks following REST instruction to encourage participants and to problem solve regarding any barriers which may be impeding their performance of REST. After the 2-week initiation phase, participants will perform REST independently during an 8 week training phase but will be encouraged to contact the PT with any questions or difficulty. Patient reported outcome (PROs) measures will be collected at baseline prior to REST instruction and after completion of the 2-month training phase, as outlined below.

Baseline assessment and REST instruction. Patients will be examined and instructed in their REST programs on a day when they will be visiting the Mayo clinic either for treatment or evaluation. REST will not be feasible if it adds to patients' already significant travel demands. The PI will obtain a functional history and perform a routine physical examination on all patients to ensure that they may safely participate and to identify impairments or physical vulnerabilities that will require individualizing their REST program. A tailored REST fitness program will be developed for each patient by a PT specialized in cancer rehabilitation. Patients will be provided with upper and lower extremity REST routines (each requiring 7 minutes) designed to maintain core and appendicular strength with minimal burden. The REST lower extremity routine will include 6 exercises and will target the hip flexors, hip abductors, hip extensors, knee extensors, knee flexors, shoulder stabilizers, and back extensors. The REST upper extremity routine will include 5 exercises and will target the elbow extensors, elbow flexors, shoulder stabilizers, shoulder flexors, and abdominal muscles. Each routine can be performed at 1 of 3 intensity levels depending on how participants feel on a given day. Each of the routines is performed twice per week for a maximum total of 28 minutes of resistive strengthening per week. The standard REST lower extremity program is performed in a standing position; however the program can be adapted for seated performance. Note that the REST program can also be individualized to accommodate impairments such as degenerative arthritis, back pain and osseous instability.

Subjects will also be dispensed a pedometer and encouraged to wear it daily for the first 2 weeks of their study enrollment in order to establish an average baseline number of steps per day. Thereafter they will be instructed to wear the pedometer 3 times per week and to chart the number of steps taken between waking and retiring to bed and encouraged to 'make up' for days/weeks when fewer steps are taken due to increased symptom burden, post-chemotherapy fatigue, or other contingency.

Subjects will be provided with laminated cards illustrating their REST program to encourage their adherence. They will also receive a ring bound monthly calendar with their REST program illustrated on the top and a calendar on the bottom with designated boxes for number of pedometer recorded steps per day and to indicate which (if any) tier of the REST program they completed on a given day. Calendars will be submitted for analysis at the end of the 2 month study period. Modified laminated cards and calendar pages will be provided if changes in their health status require alterations of their REST program.

Initiation phase. Participants will be encouraged to perform their upper extremity and lower extremity REST programs twice per week. After the first week, they will follow up with the study PT by telephone to address any questions they may have and to address any difficulties with REST. The PT may adjust their REST program if it proves uncomfortable or overly fatiguing. Participants will continue to perform the REST program with any modifications for the second week after training. They will again follow up with the study PT by telephone at the end of the second week to address any issues. Dr. Cheville will serve as resource for the study PT during the initiation phase in case he/she has any questions regarding symptom control or the safety of REST.

Training phase. Following the initiation phase the participants will continue to perform their REST programs 4 times per week (2 upper and 2 lower extremity) for 8 weeks. While no follow up telephone calls will be scheduled with the study PT, participants will be encouraged to contact the PT with any questions or difficulties. The PT will consult Dr. Cheville on an as needed basis.

Data Collection Patient-Reported Outcome (PRO) Measures. Baseline PROs will be collected after subjects sign informed consent, following randomization and, for intervention group members, before the PTs instruct them in the REST exercises. Week 10 PROs will be mailed to the patients with a postage paid return envelope. Participants who do not respond in the first week will be sent a second mailing. Subjects will receive $25.00 compensation for completing each set of PROs, for a total of $50.00.

Ambulatory Post Acute Care Basic Mobility and Daily Activity Short Forms FACIT-F Outcome Expectations for Exercise Self Efficacy for Exercise North Central Cancer Trials Group Patient Quality of Life-Linear Analogue Self Assessment (LASA) Scale. The LASA Scale is a single item measurement of global quality of life rating on a numerical rating scale from 0 to 10 with well established validity data in cancer populations.38 Other Treatments. Oncological care will be not affected by this study: subjects will continue to make their routine clinic visits and receive oncological cares as usual. Analgesic medications will be permitted (and assessed), to adjust for co-intervention differences between groups in the analyses.

STATISTICAL ANALYSIS Descriptive statistics will be calculated for participants' demographic and lung cancer-related characteristics, as well as their function- and symptom-related PROs. Descriptive statistics will also be calculated for the data collected by the study PT regarding the frequency of specific problems (e.g. shoulder pain with REST) encountered during the initiation phase, as well as the number of calls per participant during the training phase, time per call, and reasons for these calls.

Data collected from patients' calendar records of REST adherence and steps per day will be described in terms of proportions and means, respectively. An arbitrary threshold of 75% will be used to distinguish participants who did and did not adhere to the recommended 4 sessions per week. Participants who did not perform their REST program 4 times per week for at least 6 of the 8 weeks during the training phase will be considered non-adherent. Exploratory analyses of significant differences between participants that did and did not adhere will be performed with nonparametric testing.

The normality of the PROs will be assessed by testing of skew and kurtosis. Nonparametric statistical tests will be used to evaluate PROs that are not normally distributed. Student's paired T-test will be used to estimate the effect of the intervention on primary and secondary outcomes. Additionally, the Wilcoxon rank sum test will be used to compare the degree of change in these scores between patients randomized to the intervention group who did and did not comply with REST. The magnitude and directions of the relationships between change in mean steps per day during the training interval (calculated as mean from week 10 minus mean from baseline) and changes in PRO scores will be assessed with Pearson correlation coefficients. Given the pilot nature of this work, adjustments will not be made for multiple comparisons.

Rapid Easy Strength Training (REST) to Improve Function in Late Stage Cancer

Phase II Randomized Controlled Trial of Rapid and Easy Strength Training to Preserve Function in Late Stage Cancer

Patient reported outcome with 18 items assessed functionality in basic mobility. Response option for all items is a 4 level Likert scale

Patient reported outcome with 15 items assessing functionality with respect to the performance of activities of daily living.

7 item patient reported outcome assessing over-all quality of life and quality of life domains, e.g. mental, social, etc.

Patient reported outcome assessing overall quality of life among patients with cancer and fatigue

Mayo Clinic

Mouth and Tooth Diseases

Digestive System Diseases

Cancer Pain

Pain

Stomatitis

Mucositis

Mouth Neoplasms

Oral Cancer

Laryngeal Cancer

Lip and Oral Cavity Cancer

Active high frequency TENS will be use for Active TENS.

Placebo TENS will be applied for one arm of the study

Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).

Transcutaneous Electrical Nerve Stimulation (TENS)

Jennifer E Lee, PhD

The overall goal of this study is to examine the effect of a single dose of TENS on mucositis pain and function secondary to head and neck radiation therapies. Oral mucositis is an extremely debilitating, unpreventable condition (inflammation, ulcers, bleeding in the mouth, nose, and throat) that causes significant pain, functional impairment, and diminished quality of life. Head and neck cancers pose specific challenges to effective pain management and past studies suggest the use of effective non-pharmacologic strategies such as TENS may be particularly beneficial for avoiding sources of acute and chronic pain, thereby improving quality of life. The investigators hypothesize that a single dose of TENS will decrease pain and improve function and quality of life in head and neck cancer patients. This project is particularly innovative because it is the first known study to examine the efficacy of TENS, an established safe, inexpensive and easy-to-use non-pharmacologic pain management intervention, for treating acute oral mucositis pain. The investigators research translates bench (animal model) science to human subjects using an interdisciplinary approach to pain management. Establishing whether TENS is effective for reducing mucositis pain is a critical first step toward establishing an effective, non-pharmacologic pain relief intervention for mucositis.

Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)

The Influence of TENS on Mucositis Pain and Function in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double Blind Clinical Trial

Participants rated 0-10 pain intensity in head/neck cancer area using one number (where their disease was located) by a vertical line on a horizontal 10-cm visual analog scale (VAS) from 0 "no pain" to 10 "worst possible pain." Possible scores ranged from 0-10 (10=worse pain). VAS was assessed two times each visit: (1) Pre-VAS: start of visit, (2) Post-VAS: end of the visit. The outcome measure was each person's change in pain: Pre-VAS minus Post-VAS, to create VAS change score. An average of all participants' VAS change score was calculated for each TENS condition (Active, Placebo, No TENS) and used as the dependent measure.

Jennifer E. Lee

Post Doctoral Research Fellow

Active high frequency TENS will be use for Active TENS.

Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).

Active TENS

Low Intensity TENS will be applied for one arm of the study

Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).

Low Intensity TENS

TENS unit in place but not turned on

Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).

No Treatment

All participants' characteristics, prior to first treatment

All Participants

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Jen Lee

Each participant received an Active TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Active TENS condition. Active TENS was delivered for 30 minutes at a frequency of 125Hz and a pulse duration of 100 2s on continuous mode output (calibrated using an oscilloscope before the study). Transcutaneous electrical nerve stimulation intensity was increased by the allocator until patients reported a ''maximally strong but comfortable sensation'' to ensure an analgesic effect.

Each participant received an Placebo TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Placebo TENS condition. Placebo TENS parameters were identical to active TENS (125 Hz, 100 2s). A novel, transient placebo TENS unit, previously tested and validated, was used. The intensity was increased until patients first felt ''any sensation at all (sensory threshold)'' in any electrode (ie, they did not have to reach sensory threshold in all electrodes). The placebo device then provided a current for 30 seconds and decreased gradually over 15 seconds to 0 output (ie, 45 seconds from the first sensory threshold). An indicator light remained on for the remainder of the visit so it appeared to the participant and outcomes assessor that the unit was still producing current.

Placebo TENS

Each participant received a No TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the No TENS condition. No TENS parameters were identical to active and placebo TENS, except that (1) the unit was never turned on and (2) participants were told that the unit was not on.

No TENS

The sample was adults (18 or greater) years old with oropharyngeal or laryngeal cancer.

Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS)

Active high frequency TENS will be used visit 1 Washout 6 days Placebo for visit 2- 7 days after visit 1 Washout for 6 days No tens visit 3- 7 days after visit 2

Order: Active, Placebo, No TENS

Placebo low frequency TENS will be used visit 1 Washout 6 days Active high intensity TENS for visit 2- 7 days after visit 1 Washout for 6 days No tens visit 3- 7 days after visit 2

Order: Placebo, Active, No TENS

No TENS will be used visit 1 Washout 6 days Active high intensity TENS for visit 2- 7 days after visit 1 Washout for 6 days Placebo Low Intensity TENS visit 3- 7 days after visit 2

Order: No TENS, Active, Placebo

Overall Study

Musculoskeletal Diseases

Nervous System Diseases

Skin and Connective Tissue Diseases

Neuroma

Morton Neuroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Metatarsalgia

Foot Diseases

Joint Diseases

Neuralgia

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Customized insole with metatarsal support

Insole

Placebo Insole

Objective: The aim of the present study was to assess the effectiveness of insole with metatarsal support on pain in patients with Morton's neuroma and the impact of this insole on function, load distribution in the plantar region, gait variables, quality of life and satisfaction with insole use.

Methods: A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Seventy-two patients with Morton's neuroma were randomly allocated into a study group and control group. One week following the baseline evaluation, the study group received insole with metatarsal support made of ethyl vinyl acetate and the control group received a flat insole of the same material, color and density. The groups were evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters employed: pain when walking and at rest (END); quality of life (SF-36); foot function (FFI and FHSQ); six-minute walk test (6MWT) and foot pressure analysis using the AM Cube FootWalk Pro program.

Insole on Morton's Neuroma

Effectiveness of Insole on Morton's Neuroma

Measured by visual analogue scale from 0 cm to 10 cm

Measured by Foot function index questionnaire

Measured by Foot Health Status questionnaire

Measured by the distance in the six minute walking test

Measured by the Short Form -36 questionnaire

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Federal University of São Paulo

PT, MsC

40 minutes of physiotherapy, based on manual therapy sessions over 6 weeks. Three times a week.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RN-Led Palliative and Supportive Care Intervention	NCT04570709	Acute Myeloid L...	Palliative And ...	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
Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change	NCT01006902	Cancer		65 Years - 90 Years	University of Vermont
Online Cancer-Related Fatigue Management	NCT05017597	Neoplasms Fatigue	Rehabilitation	18 Years - 70 Years	Eastern Kentucky University
The CARE Program: CAncer REhabilitation Pilot Study for Older Adults	NCT02306252	Cancer	Occupational an...	65 Years -	UNC Lineberger Comprehensive Cancer Center
Rapid Easy Strength Training (REST) to Improve Function in Late Stage Cancer	NCT01334983	Cancer	REST	18 Years -	Mayo Clinic
Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)	NCT01194466	Head Cancer Neck Cancer Pain	Transcutaneous ...	18 Years - 90 Years	University of Iowa
Rapid Easy Strength Training (REST) to Improve Function in Late Stage Cancer	NCT01334983	Cancer	REST	18 Years -	Mayo Clinic
Insole on Morton's Neuroma	NCT03511677	Morton Neuroma	Insole Placebo Insole	18 Years -	Federal University of São Paulo
Comprehensive Assessment of Head and Neck Cancer Survivors	NCT01222481	Head and Neck C...		40 Years -	Washington University School of Medicine
Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)	NCT04145180	Head and Neck C... Pain Dysfunction	Manual therapy	18 Years - 75 Years	Universidad de Granada
Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)	NCT04145180	Head and Neck C... Pain Dysfunction	Manual therapy	18 Years - 75 Years	Universidad de Granada
Management of Bone Defects Around the Elbow	NCT00873145	Tumor Fracture Cancer	HMRS	-	Medical University of Vienna

Spots Global Cancer Trial Database for function

Every month we try and update this database with for function cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for function

Every month we try and update this database with for function cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for function cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.