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Clinical Research Studies

The ONE Group (Oncology – Nutrition – Exercise) at Penn State College of Medicine is leading a number of studies seeking to better understand the role of diet and activity in people who have or have survived cancer.

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Ongoing Studies

CUFF (Characterization of Upper Limb Function following Mastectomy and Reconstruction for Breast Cancer) Expand answer

Principal investigator: Meghan Vidt, PhD

Study aims

Approximately one in eight women will be diagnosed with breast cancer, but with improvements in diagnosis and treatment in recent years, only one in 38 patients will die from breast cancer. Cancer treatment often includes a mastectomy, with mastectomy rates increasing over the past decade. Frequently, these patients also elect to undergo breast reconstruction. Breast reconstruction following mastectomy is often an important aspect of a patient’s treatment, as it provides physical restoration and can improve psychological well-being. However, there are different approaches to reconstruction, including use of implants, autologous flaps or a combination of implants and autologous flaps. It is unclear whether the reconstructive approach used in a patient’s treatment affects shoulder/upper limb function and perceived well-being following surgery.

The primary outcome for this study is range of motion, which is a measure of shoulder/upper limb mobility and function. Secondary outcomes for the study include self-reported questionnaires, which look at demographics, overall health, shoulder function, body image and ability to return to work.

Objective measurements of function include shoulder/upper extremity strength, range of motion in all degrees of freedom, and pectoralis major and pectoralis minor resting lengths. Outcomes from post-reconstruction interviews include topics related to aspects of treatment, function, quality of life and return to work.

The CUFF study has the potential for surgeons to help patients make a more informed decision regarding their reconstruction based on their lifestyle. There is also the potential to expand the current study to involve a prehabilitation setting, similar to the IMPROVE-B trial.

Methodology

This study is an observational study that will look at measurements related to upper extremity function and perceived health. Breast cancer survivors who have had mastectomy with or without reconstruction will be assessed in this study at two time points: before mastectomy and three months after reconstruction, or three months after mastectomy if no reconstruction is planned. Outcomes will be compared between time points and groups to evaluate whether reconstruction approach influences measures of upper limb function.

Study status

This study is currently enrolling.

See details on StudyFinder

EXALT (Exercise Attenuates Liver Tumors) Expand answer

Principal investigator: Jonathan Stine, MD, MSc

Funder: American Cancer Society

Study aims

In most cases of early stage hepatocellular carcinoma (HCC), logoregional therapy as a bridge to liver transplantation offers the greatest survival benefit. The great inequity that exists between organ supply and demand in liver transplantation may increase a candidate’s waiting-list time from months to years. This can increase the likelihood of HCC recurrence, disease progression and loss of transplant candidacy. Preventing HCC recurrence is paramount in order to allow more patients to undergo lifesaving liver transplantation to achieve the best long-term survival outcome. Exercise may provide a beneficial approach to address this problem as through changes in blood flow and inflammation, exercise is beneficial in other types of cancers including breast, prostate and lung.

The primary objective of EXALT is to assess the feasibility, safety and acceptability of an exercise program that combines both strength training and aerobic exercise. Changes in inflammation, body composition and frailty will also be measured following exercise.

Methodology

EXALT is a two-arm randomized control trial for HCC patients.

A history and physical exam and electrocardiogram will be completed at baseline to ensure safety of exercise. Frailty will be assessed using Fried Frailty Index, Hand Grip Strength, Liver Frailty Index and the Short Performance Physical Battery. A blood draw for inflammatory markers, body composition testing and physical activity questionnaires will be completed.

Participants in the intervention group will begin a 12-week intervention where they will undergo two strength training session per week with an exercise professional. Training will include teaching proper warm-ups, use of equipment, exercise form, mode of activity, intensity of exercise, flexibility exercises and cooldown. Additionally, participants will be instructed to complete 30 minutes of moderate-intensity aerobic exercise on three additional days during the week. This will be monitored remotely with a FitBit Charge HR 3 fitness activity tracker to ensure compliance.

Those in the control group will be instructed to continue their medical care at the discretion of their treating medical professional. Weekly phone calls will be performed to ensure adherence to the protocol.

Following the 12-week study period, subjects in both the control and intervention groups will then enter a 24-week follow-up period with measurement of three- and six-month post-exercise outcomes.

Study status

This study is currently enrolling.

See details on StudyFinder

FORCE (Focus on Reducing Dose-Limiting Toxicities in Colon Cancer with Resistance Exercise) Expand answer

Principal investigator: Kathryn Schmitz, PhD, MPH

Study aims

Reductions in dose intensity of chemotherapy are associated with lower survival in many cancers, and the identification of ways to reduce dose intensities is of tremendous clinical significance. Low muscle mass is a highly prevalent and an occult problem among newly diagnosed colon cancer patients and is associated with dose-limiting toxicities (DLT). Resistance training (RT) is known to increase muscle mass, and increases in muscle mass could reduce DLT with a potential impact on survival.

FORCE has the potential to expand the knowledge between chemotherapy and muscle mass, while providing physicians an alternative of resistance training to help manage chemotherapy side effects of their patients.

Methodology

FORCE is a multi-site, two-arm, randomized controlled trial for newly diagnosed, Stage II and III, colon cancer patients. The primary objective of FORCE is to compare the effect of a RT intervention vs. a waitlist control on chemotherapy dose reduction, dose delays, early discontinuation of chemotherapy and treatment-related toxicity.

A physical and diet assessment, DXA scan, medical outcomes and fatigue questionnaires, chemotoxicity questionnaire by a medical professional and a blood draw for inflammatory markers will be conducted during the baseline and post-intervention visits.

Participants in the intervention group will undergo an approximately six-month-long intervention period, where they will undergo six in-person training sessions with an exercise professional (at two-week intervals) plus a weekly phone call. During the training session, participants will be taught an in-home exercise program that they should perform twice per week. Participants will also be instructed to consume a serving of protein powder twice a day. An exercise and nutrition log will be given to track adherence to the protocol. RT exercises will be progressive after each training session throughout the intervention period, with the goal to achieve a 1 kg increase in lean body mass.

Participants in the waitlist control group will be told to continue whatever exercise program they have been undertaking up to study enrollment, but not to increase exercise or begin weight-lifting over the period of study participation.

Study status

Enrollment for this multi-site study has concluded at Penn State but continues at other locations. Research is underway with data collection to be completed by June 2021.

IMPROVE-BMT (Impact of Prehabilitation in Oncology via Exercise - Bone Marrow Transplant) Expand answer

Principal investigator: Melanie Potiaumpai, PhD

Funder: National Cancer Institute

Study aims

Current evidence suggests that exercise is safe for patients who have received a bone marrow transplant, while helping to maintain physical function and psychosocial well-being. Despite the increasing number of exercise-related studies on bone marrow transplant patients during and after primary treatment (also known as rehabilitation), studies focusing on the feasibility and efficacy of prehabilitative exercise among bone marrow transplant patients are widely missing.

Prehabilitation is a process on the cancer continuum of care that occurs between the time of cancer diagnosis and the beginning of acute treatment. Given the accumulating evidence of exercise-induced benefits among bone marrow transplant patients during and after treatment, exercise should be considered as a key element for prehabilitative approaches.

In other cancer entities, prehabilitative approaches were successful among colon and lung cancer patients, improving physical fitness and lowering the risk of associated postoperative complications, shorter hospital stays, and reduced mortality.

The primary objective of IMPROVE-BMT is to assess the feasibility, acceptability, and safety of prehabilitative exercise in bone marrow transplant patients. Secondary objectives include aerobic endurance, physical function, fall risk and patient-reported outcomes such as health-related quality of life, fatigue, sleep, depression and physical activity levels.

Physical function and psychosocial measures are conducted at baseline prior to prehabilitation, prior to the bone marrow transplant, 30 days post-transplant, and 100 days post-transplant.

IMPROVE-BMT has the potential to elucidate how prehabilitative exercise can act as a preventive method against treatment-related complications and improve long-term survival.

Methodology

IMPROVE-BMT is a randomized controlled two-arm trial comparing home-based exercise (EX) vs. usual care educational program control group (CONT) in patients prior to receiving a bone marrow transplant. Patients in the EX group will receive an exercise manual and equipment for individualized home-based exercise and a practical introduction by an exercise and cancer specialist, while the CONT group will receive a one-on-one educational session.

Study status

This study is currently enrolling.

Nurse Alexa Expand answer

Principal investigator: Kathryn Schmitz, PhD, MPH

Study aims

The ONE Group previously developed the Nurse AMIE (Addressing Metastatic Individuals Everyday) electronic supportive care platform to help women with metastatic breast cancer to manage their symptoms without additional in-person clinic appointments.

The main reason women gave for not wanting to join the Nurse AMIE study was being overwhelmed by the technology (having to interact with a tablet each day). One way to overcome this hurdle was to create the Nurse AMIE platform as an Amazon Alexa skill to work with Amazon Echo Show devices. This would allow participants to interact with Nurse Alexa simply using their own voice, eliminating the need to interact with the tablet.

Nurse Alexa is a collaboration between Dr. Katie Schmitz, Dr. Saeed Abdullah (Assistant Professor of Information Sciences and Technology at Penn State) and Dr. Renate Winkels (Assistant Professor of Human Nutrition and Health, Wageningen University and Research in the Netherlands). Together, they are working to recode the current Nurse AMIE program into Nurse Alexa, so that women with metastatic breast cancer can interact with the supportive care platform using audio controls rather than having to physically open up a tablet.

Additionally, the group is creating a nutrition module to incorporate into the existing Nurse AMIE content. Users of the Nurse Alexa platform will be able to get nutrition information along with recipes that are tailored for women with metastatic breast cancer.

The goals of Nurse Alexa are to regularly assess mental health, physical health and other symptom-related needs among Stage IV breast cancer patients and to provide appropriate supportive care via videos and text, as well as appropriate referrals to phone or in-person visits (as needed). The proposed Nurse Alexa program will allow for the plan of resources (videos, audio files, exercises and recipes) to help with many of the common symptoms and challenges experienced by the patients. This is an identified need on the part of both the patients and their medical care teams.

Methodology

The group proposes to build and test the usability of the Nurse Alexa supportive care platform in a sample of 10 women with metastatic breast cancer who live within Penn State Cancer Institute’s 28-county catchment area.

Each participant will receive an Amazon Echo Show device, along with a pedometer and resistance band to engage in the physical activity modules within the program. After the usability of the program has been deemed acceptable, the study team will test the effectiveness of the Nurse Alexa program to assess and address symptoms of cancer and associated treatment. This will be tested with a sample of 44 women with metastatic breast cancer from Penn State Cancer Institute’s catchment area.

Participants will undergo a pre-test to determine baseline measures such as functional status, pain, fatigue, symptoms, sleep and psychosocial distress. This is a 90-day intervention to include seven modules: movement, soothing music, connect, relaxation, living voice, symptom management and nutrition. A post-test using the same baseline measures will be conducted after the program.

Study status

This study is currently enrolling.

Nurse AMIE (Addressing Metastatic Individuals Everyday - a Tablet-Based Supportive Care Platform in Metastatic Breast Cancer) Expand answer

Principal investigator: Kathryn Schmitz, PhD, MPH

Study aims

Women living with metastatic breast cancer often are living with symptoms that are left unmanaged, resulting in more visits to Penn State Cancer Institute for symptom complications. Given the pressing need to address medical issues, there is scant time during these visits to address the myriad other issues metastatic patients face, such as pain, fatigue, psychosocial concerns and other quality-of-life-related concerns.

The Schmitz lab has developed a software program called Nurse AMIE (Addressing Metastatic Individuals Everyday) for Stage IV breast cancer patients with the intention to provide high-quality care for presently unmet needs without additional in-person visits. The goals of Nurse AMIE are to regularly assess quality of life, physical health and other symptom-related needs. Based on the reported symptoms, Nurse AMIE will provide appropriate help via six modules: exercise videos, soothing music, connection through breastcancer.org, guided relaxation, daily step counts and symptom management videos.

Additionally, there will be weekly calls with a patient navigator who can help with symptom management and facilitate referrals to phone or in-person visits when needed.

Nurse AMIE has the potential to change the way clinicians approach symptom management with their metastatic patients and improve their quality of life.

Methodology

The Nurse AMIE study is a randomized trial to assess the acceptability and feasibility of the tablet-based program Nurse AMIE. The group seeks to recruit 25 women from Penn State Cancer Institute. Participants randomized to the immediate intervention group will begin the intervention at baseline for 90 days. After 90 days, participants will no longer need to interact with the program and will be monitored for another 90 days. The delayed intervention group will begin with a 90-day monitoring period before beginning the intervention for 90 days. After participating in the intervention, participants will no longer need to interact with the program and will be monitored for another 90 days.

Study status

This study is currently enrolling.

See details on StudyFinder

REJOIN (Using Exercise to Relieve Joint Pain in Older Breast Cancer Survivors) Expand answer

Principal investigator: Shirley Bluethmann, PhD, MPH

Funder: American Cancer Society

Study aims

Adjuvant hormonal therapy, like aromatase inhibitors (AI), has been demonstrated to reduce recurrence and mortality in estrogen-receptor-positive breast cancer survivors, most of whom are older than 65. Arthralgia (i.e., joint pain) is a common side effect of AIs that may degrade function and impede adherence. Arthralgia affects 50 percent of AI users and is a common reason survivors stop hormonal therapy before the recommended duration of five or more years. Yet, few clinical interventions address this concern.

Recent trials have shown that physical activity (PA) is underutilized yet effective for improving AI-induced arthralgia. Further, it has been suggested that providing education about AI symptom management strategies may contribute to better AI adherence. Yet, few interventions have combined education and exercise to address this challenge.

The objective of this study is to assess the effectiveness of a self-management intervention (combining education-and exercise-based strategies) for AI-induced arthralgia in older survivors (older than 65 years old). The team hypothesizes that combining education- and exercise-based strategies may improve arthralgia and increase AI adherence compared to standard care.

There are three specific aims to this study:

  • First, adapt an evidence-based PA intervention based on educational needs of older cancer survivors planning to take AIs, by conducting a needs assessment to develop content on AIs and arthralgia, adding a geriatric assessment to the curriculum, and conducting an open pilot to pre-test suitability of the adapted module.
  • Second, test the effect of a pilot intervention on arthralgia and behavioral predictors for AI medication adherence (e.g., knowledge and self-efficacy).
  • Third, test the effect of a pilot intervention on AI adherence.

With older survivors being at high risk of early discontinuation of hormonal therapy, REJOIN has the potential to help patients address their specific barriers to AI adherence and empower the patients to live healthier lives while mitigating side effects, like joint pain, of their medication, which is essential for maintaining their survivorship.

Methodology

This study will be a randomized controlled pilot trial. Two groups will be randomized to either information-only (enhanced standard care) or education plus exercise (treatment). Survivors will be recruited prior to completing primary treatment, as arthralgia can occur soon after AI initiation. At the first visit, survivors in both groups will receive an ACS brochure with their AI prescription. For the treatment group, the team will adapt an evidence-based program for seniors that includes bi-weekly sessions with 60 minutes of supervised exercise (low-impact aerobics plus light weights) and 30 minutes of education and discussion (90 minutes total per session). The eight-week program would occur in a community facility followed by an eight-week home version, reinforced with phone counseling.

The team will conduct a geriatric plus baseline assessment of knowledge, PA, joint pain and AI adherence during the trial. These will be measured again at four, six and 12 months.

Study status

This study is currently enrolling.

See details on StudyFinder

WISER-NET (Women in Steady Exercise Research - Neoadjuvant Exercise Trial) Expand answer

Principal investigator: Kathleen Sturgeon, PhD, MTR

Funder: NRG Oncology

Study aims

Exercise participation is widely recommended for all persons following a cancer diagnosis, with evidence suggesting that aerobic exercise training is not only safe during primary adjuvant therapy but also improves cardiopulmonary function and patient-related outcomes.

Aerobic exercise training prescriptions incorporating high-intensity exercise elicit superior improvements in exercise capacity compared with standard- to moderate-intensity exercise prescriptions. However, few studies have tested the efficacy of exercise prescriptions that incorporate high-intensity aerobic exercise training in cancer patients, especially those receiving chemotherapy.

The primary aim of WISER-NET is to determine whether breast cancer patients can be enrolled, randomized, retained and comply with six months of aerobic exercise training. In addition, the study aims to examine the feasibility of acquiring, managing and analyzing cardiopulmonary fitness, cardiac function, quality of life and tumor response data.

Information obtained from this research may benefit breast cancer patients by demonstrating safety and efficacy of an at-home-based aerobic exercise intervention.

Methodology

WISER-NET is a two-arm, randomized, controlled trial comparing the home-based aerobic exercise training intervention group with the control group. The aerobic exercise intervention group will work toward the target of 75 minutes of treadmill walking per week at 60% to 85% of baseline VO2max over a period of 24 weeks. Participants in the intervention group will be oriented to the exercise intervention in person during the baseline testing, after which they will receive a treadmill shipped to their homes. An exercise physiologist will provide ongoing support and monitoring of adherence in person at infusion sessions and via phone. Participants in the control group will be asked to maintain their usual level of physical activity during study participation.

All subjects will undergo a treadmill exercise test to estimate maximal oxygen consumption (VO2 max) as an index of cardiopulmonary fitness.

Quality-of-life surveys will be administered during the first chemotherapy infusion session, a midpoint chemotherapy session and at the last neoadjuvant chemotherapy session.

Study status

This study is currently enrolling.

See details on StudyFinder

Previous Studies

CAPABLE (Health-Related Factors Among Cancer Survivors in Pennsylvania) Expand answer

Principal investigator: Kathryn Schmitz, PhD, MPH

Study aims

Behavioral health risk factors may differ between the general population and cancer survivors. However, no previous survey examined the difference between the general population and cancer survivors.

The purpose of this study is to:

  • examine the health-related risk behaviors, chronic health conditions and preventive services among cancer survivors in the Penn State Cancer Institute catchment area that could help clinicians and researchers to comprehensively understand the behavioral risks and resources and to develop better interventions in the clinical setting;
  • compare the differences between general population and cancer survivors that could direct clinical guidelines and policy change; and
  • assess quality of life and financial burdens that could help clinicians and researchers to understand the current needs and to optimize resources for cancer survivors.

Methodology

Nearly 2,500 behavior risk factor surveillance system (BRFSS)-based questionnaires were mailed to breast, lung, colorectal, prostate and gynecologic cancer survivors (500 each).

Study status

This study has concluded and results are being disseminated. Works include:

EnACT (Exercise in All Chemotherapy) Expand answer

Principal investigator: Kathryn Schmitz, PhD, MPH

Study aims

Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. However, despite guidance on implementing exercise recommendations for cancer patients, exercise counseling is still not a standard of care in cancer centers across the United States.

This study aims to collect data that will assist with translation of evidence from randomized controlled trials into standard of care.

EnACT is a single group, pre-post intervention study to capture the effects of an exercise intervention on the average chemotherapy patient, as well as qualitative input regarding the value of, burden associated with, and appropriateness of the exercise intervention from oncology clinicians (one year following start of study).

The EnACT project’s goal is to conduct a safety and feasibility study to assess patient interest in exercise, adherence to exercise during chemotherapy and logistics of operating an exercise intervention program in the infusion suite. The study team hopes to gather data that will lead to externally funded dissemination and implementation research grants on the benefits of exercise during chemotherapy.

Methodology

Participants will undergo an exercise intervention that utilizes the “Moving Through Cancer: A Guide to Exercise for Cancer Survivors” framework. Participants will undergo a baseline physical functioning testing for balance and strength. Each participant will then be provided with a specific exercise prescription tailored by the cancer exercise physiologist based on the treatment, cancer type and the participant’s physical functioning. Participants will be instructed to exercise on their own, at home, according to the instructions from the cancer exercise specialist. The length of the study will be between three and 12 months, depending on the length of the participant’s chemotherapy.

Study status

This study has concluded and results are being disseminated. Works include:

IMPROVE-B (Impact of Prehabilitation in Oncology via Exercise - Breast Cancer) Expand answer

Principal investigator: Kathryn Schmitz, PhD, MPH

Study aims

Current evidence suggests that exercise is not only safe for breast cancer patients undergoing primary adjuvant therapy, but it also improves physical function and quality of life outcomes. Despite the increasing number of exercise-related studies on breast cancer patients during (adjuvant chemotherapy and radiotherapy) and after primary treatment (rehabilitation), investigations focusing on the feasibility and efficacy of prehabilitative exercise among breast cancer patients are widely missing.

Prehabilitation is a process on the cancer continuum of care that occurs between the time of cancer diagnosis and the beginning of acute treatment. Given the accumulating evidence of exercise-induced benefits among breast cancer patients during and after treatment, exercise should be considered as a key element for prehabilitative approaches.

In other cancer entities, prehabilitative approaches were successful among colon and lung cancer patients, improving physical fitness and lowering the risk of associated postoperative complications, shorter hospital stays and reduced mortality.

The primary objective of IMPROVE-B is to assess safety, feasibility and acceptability of prehabilitative exercise in breast cancer patients.

Methodology

The study is a randomized controlled three-arm trial comparing supervised exercise (SE) vs. home-based exercise (HE) vs. educational program (ED) control group of patients prior to breast cancer treatment.

Patients in the HE group will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist, while the SE group will undergo a one-week supervised training camp trained by certified fitness professionals on resistance and aerobic training followed by the home-based exercise program.

Patients in the ED control group (as well as participants in the SE and HE groups) will receive a two-hour group-based prehabilitation class. Physical performance testing on muscle strength, endurance and physical functioning as well as patient-reported outcomes such as adherence, Edmonton symptom, quality of life, fatigue, sleep and depression will be conducted at baseline (prior to intervention) and prior to breast surgery.

Patient-reported outcomes will also follow through prior to chemotherapy/radiation therapy and after completion of primary treatment.

Study status

This study has concluded and results are being disseminated.