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Musculoskeletal Diseases

Prostatic Neoplasms

Arthritis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

Men age 65 and older who are undergoing active surveillance as primary treatment for their prostate cancer.

Men age 65 and older who are undergoing radiation only as primary treatment for their prostate cancer.

Men age 65 and older who are undergoing endocrine therapy as primary treatment for their prostate cancer.

Men age 65 and older who are undergoing surgery as primary treatment for their prostate cancer.

A six week walking program by the Arthritis Foundation

Walk with Ease

Hyman Muss, MD

This study is testing a walking program called Walk with Ease by the Arthritis Foundation with men undergoing treatment for prostate cancer. The researchers are interested in how easy or difficult it is for these men to participate in this program and whether or not is is helpful to them during their care.

Purpose: This pilot study evaluates the feasibility of implementing a moderate-intensity physical activity (PA) program in a sample of men age 65 or older with a prostate cancer diagnosis undergoing various forms of treatment or active surveillance.

Participants: Men, 65 and older, with a prostate cancer diagnosis.

Procedures (methods): This study will enroll subjects in a 6 week walking program called Walk with Ease (WWE) and see if walking can be sustained for up to three months. In addition, the study will perform a Geriatric Assessment and gather preliminary data on self-reported quality of life outcomes and self-reported physical activity as captured in a daily walking log.

Using Walk With Ease Walking Program With Men 65 and Older Being Treated for Prostate Cancer

Feasibility of an Evidence-based Walking Program in a Sample of Men Age >65 Undergoing Treatment for Prostate Cancer

To explore data from the measures/assessments (summary measures at each time point and mean changes at 6 weeks and 3 months) to inform future studies designed to evaluate associations between the WWE program and these variables.

Exploring the evaluate the feasibility of implementing the WWE intervention among men age \>65 with a prostate cancer diagnosis. The study will measure those who were able to complete the program and increased their self-reported level of walking. The study will also measure the percent of patients who reach the goal of walking 30 minutes a day for 5 days a week in order to determine feasibility.

To evaluate the rate of completion of each of the following measures/assessments at 3 different time points -- baseline, 6 weeks (end of WWE intervention), and 3 months (follow-up):

* Self-reported walking log
* Functional Assessment of Cancer Therapy-General (FACT-G)25
* Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue26
* Outcome Expectations for Exercise (OEE) scale27
* Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM)28,29
* Visual Analog Scales (VAS) for Pain, Fatigue and Stiffness30-32
* PROMIS Pain Interference Short Form 6b33-35
* BRFSS Questionnaire 2011 -Health Behaviors Questionnaire (HBQ)36
* Geriatric Assessment (GA) (Version 5)

UNC Lineberger Comprehensive Cancer Center

Symptoms and General Pathology

Fatigue

Asthenia

This arm will begin the Walk With Ease program after the completion of chemotherapy.

The arm will begin the Walk With Ease program three months after completion of chemotherapy.

Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.

Walk With Ease

Hyman B Muss, MD

This study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue.

The investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. The design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). The primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.

The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older

A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)

Change in fatigue will be measured using the FACIT-F.

This outcome will be measured by the Brief Fatigue Inventory

To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team.

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Engagement in walking (total minutes per week) as measured by engagement in physical activity questions

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Physical function as measured by SPPB

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression.

Breast Cancer Research Foundation

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Breast Cancer patients undergoing chemotherapy will participate in the Walk with Ease program during their treatment.

This study will look at whether or not participating in a physical activity intervention during chemotherapy for breast cancer can prevent a marker of aging called p16 from having a large increase after chemotherapy.

Our research team has determined that p16INK4a - a biomarker of aging -- increases dramatically during chemotherapy and that p16 levels among patients of similar age are lower among those who exercise. We hypothesize that engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To test this hypothesis, we propose to enroll 48 patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy in a physical activity intervention program. Our primary objective is to compare the change in p16 from baseline to end of chemotherapy for participants in this study (who are engaged in a physical activity intervention) to the mean change in p16 seen in a previous study of similar patients who did not participate in a physical activity intervention. As secondary objectives, we propose to evaluate (1) changes in treatment-related toxicity, physical function, fatigue, and quality of life between baseline, end of chemotherapy and 6 months post-chemotherapy, (2) the association of changes in p16 levels with changes in measures of treatment-related toxicity, physical function, fatigue, and quality of life, and (3) the association of changes in physical activity levels with changes in measures of treatment-related toxicity, physical function, fatigue, and quality of life.

Blood samples will be taken collect p16 levels, CBC + Differential and senescence markers.

The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer

Impact of a Physical Activity Program on Biomarkers of Aging During Adjuvant or Neoadjuvant Chemotherapy for Breast Cancer

Mean change in p16 levels measured between baseline to end of chemotherapy, as compared to the historical value seen in a previous study (LCCC810) of similar patients who did not participate in a physical activity intervention

Information obtained through patient-reported surveys and p16 levels obtained from blood samples between baseline to 6 month post-chemotherapy

Information obtained through physician and patient reported surveys.

This objective will use the surveys that measure physical function, fatigue and quality of life to see if they can make any predictions about how these domains may change over the course of chemotherapy.

Changes will be measured over the course of the study

Changes will be measured over the course of chemotherapy

Behaviors and Mental Disorders

Quality of Life

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

Walk with Ease physical activity intervention

Kirsten A Nyrop, PhD

Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a home-based, self-directed walking program can have similar benefits in women with an MBC diagnosis. The primary objective is to evaluate whether engagement in physical activity will reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study participants and measuring changes between baseline, 3 months and 6 months in additional quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30 patients. Findings from this study will provide preliminary data for a grant application to test the physical activity intervention in a randomized controlled trial (RCT) in a large sample of women with metastatic breast cancer.

Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study

Evaluate change in PROMIS Fatigue scores from baseline to 3 months

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Infective Agents

Herbal and Botanical

Sulfamethazine

Cola

This group will be receiving adjuvant chemotherapy for colorectal cancer. They will not participate in the Walk With Ease program. They will be followed up using standard of care.

This group will be receiving adjuvant chemotherapy for colorectal cancer. They will participate in the Walk With Ease (WWE) program during the course of their chemotherapy treatment. They will be requested to initiate the WWE starting on Day 1 of adjuvant chemotherapy. Participants are asked to walk at a safe and comfortable pace, increasing their minutes per day at a rate they can sustain, with the ultimate goal of 30 minutes/day for at least 5 days/week. They are asked to maintain a daily walking log that is provided to them, entering total minutes per day.

Participants will be asked to do the walking program independently (self-directed, not in a formal group with an instructor) throughout chemotherapy.

A self-directed walking intervention developed by the Arthritis Foundation. The intervention is a workbook that coaches participants through walking regularly at a safe, comfortable pace with the ultimate goal of walking at least 30 minutes a day five days a week.

Hy Muss, MD

This study will see if patient who undergo a physical activity intervention called Walk With Ease report experiencing less fatigue and a higher quality of life during chemotherapy for colorectal cancer than those who do not participate in this intervention.

The primary purpose of this multicenter, randomized controlled study is to evaluate the impact of a physical activity program on fatigue in older patients (≥60 years) undergoing adjuvant chemotherapy for colorectal cancer. The investigators also plan to evaluate physical function and quality of life as secondary objectives. The investigators' hypotheses are that people who undergo the physical activity intervention compared to those who do not, will: 1) report less fatigue, 2) report higher health related quality of life, and 3) have less decline in physical function. Additionally, The investigators will characterize ≥grade 3 adjuvant chemotherapy associated toxicities in this older population, and describe the changes reported in fatigue, physical function, and HRQOL over the course of chemotherapy.

Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer

The Impact of a Physical Activity Intervention in Older Patients Undergoing Adjuvant Chemotherapy for Colorectal Cancer: a Randomized, Controlled Trial

The investigators will compare the change in fatigue from baseline to 3 months between Intervention and Control arms as measured via PROMIS®-Fatigue.

To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.

• Physical function as measured by PROMIS-PF and SPPB

To report on the adherence of the physical activity intervention as measured through self-reported minutes of walking per days and walking minutes per week in the group randomized to the Intervention arm

The investigators will comparee the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups

The investigators will compare the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups

To explore the association of baseline measurements of p16INK4a and muscle mass with changes in fatigue, physical function, and health related quality of life during adjuvant chemotherapy.

To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.

Quality of life as measured by FACT-FCSI and PROMIS-PI

To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.

ADLs per CGA

To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.

IADLs per CGA

To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.

Self-efficacy and attitudes as measured by PSEFSM and OEE

LCCC Geriatric Oncology Program

Nervous System Diseases

Pain

Arthralgia

Joint Diseases

Neurologic Manifestations

Aromatase Inhibitors

Wait list control receiving the active intervention 6 weeks later.

Leigh F Callahan, PhD

For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This "proof-of-concept" study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.

Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

A valid and reliable Visual Analog Scale will be used to assess fatigue.

A valid and reliable Visual Analog Scale will be used to assess joint stiffness.

The Brief Pain Inventory Short Form will be used to assess pain. It is a valid and reliable instrument that has been used in other studies of breast cancer survivors.

The Western Ontario McMaster Universities Arthritis Index will be used to assess hip and knee pain and function.

Functional Assessment of Cancer Therapy-General (FACT-G)

Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2011

Self-report of any adverse events will be used to monitor safety.

Achievement of 100% recruitment of the enrollment target and 80% completion will indicate program feasibility.

Self-report of engaging in any walking level during the 6 week period by 50% of participants will indicate tolerability.

A valid and reliable 10cm Visual Analog Scale will be used to assess self-reported joint pain. This scale has been used in numerous trials.

This will be measured by the number of days walked per week and the number of minutes per walk.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Using Walk With Ease Walking Program With Men 65 and Older Being Treated for Prostate Cancer	NCT02139774	Prostate Cancer	Walk with Ease	65 Years -	UNC Lineberger Comprehensive Cancer Center
The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older	NCT02191982	Cancer Geriatric Fatigue	Walk With Ease	65 Years -	UNC Lineberger Comprehensive Cancer Center
The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer	NCT02167932	Breast Cancer Aging	Walk With Ease	21 Years - 59 Years	UNC Lineberger Comprehensive Cancer Center
Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study	NCT02682836	Metastatic Brea...	Walk with Ease	21 Years -	UNC Lineberger Comprehensive Cancer Center
Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer	NCT02191969	Colorectal Canc... Fatigue	Walk With Ease	60 Years -	UNC Lineberger Comprehensive Cancer Center
Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study	NCT02682836	Metastatic Brea...	Walk with Ease	21 Years -	UNC Lineberger Comprehensive Cancer Center
Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy	NCT01900418	Joint Pain Breast Cancer	Walk with Ease	21 Years - 99 Years	University of North Carolina, Chapel Hill
Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy	NCT01900418	Joint Pain Breast Cancer	Walk with Ease	21 Years - 99 Years	University of North Carolina, Chapel Hill
Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer	NCT02191969	Colorectal Canc... Fatigue	Walk With Ease	60 Years -	UNC Lineberger Comprehensive Cancer Center

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