RecruitingNot applicable

Distance-Based Exercise to Preserve Function and Prevent Disability

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The exercise program in this study is delivered through telehealth (TH) video calls."
  • "Evaluate objective (accelerometer) and self-reported changes (7-Day Physical Activity Recall Interview) in physical activity in the study population between baseline and the post-intervention time point."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether video calls can help people exercise at home during cancer treatment. Trained staff lead strength exercises and guide exercise patients do on their own. It is for adults ages 18–64 who are starting chemotherapy meant to cure their cancer.

This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have cancer confirmed by a tissue test in one of these areas: anus, bladder, breast, cervix, colon or rectum, lining of the uterus, esophagus (food pipe), gallbladder, head or neck, kidney, liver, lung, ovary, pancreas, prostate, or stomach; or have sarcoma (cancer of bone or soft tissue).
  • Be starting at least 10 weeks of chemotherapy that kills cancer cells, without staying in the hospital, with the goal of a cure. Other cancer treatments may be given too. Join and finish starting tests by the second chemotherapy cycle.
  • Be 18–64 years old and have worked for pay at least 30 hours a week when diagnosed.
  • Be able to walk for 6 minutes, with a walking aid if needed. Your predicted distance on a 6-minute walk test must be 550 meters or less.
  • Be able to read and understand English to use study materials and work with a coach.
  • Other treatment or supportive care studies may be allowed with approval from this study's Alliance Executive Officer and both studies' leaders.
  • Clinicians and research staff at study sites may join as clinical stakeholders if they provide care for patients in this study.
  • Clinical stakeholders must be able to speak and understand English.

Who can't join

  • Cancer that has spread to distant parts of the body.
  • Treatment with only immunotherapy or monoclonal antibodies, rather than chemotherapy that kills cancer cells.
  • Severe heart, lung, muscle, bone, or joint problems that prevent moderate exercise. Arthritis that does not prevent exercise is allowed.
  • Being pregnant or breastfeeding.
  • Current alcohol or drug abuse, or dementia (problems with memory and thinking), recorded in your medical chart.
  • Currently taking part in competitive sports, or having done strength training with increasing resistance twice a week for at least 3 months in a row during the past year.
  • Taking part in another study focused on weight loss, exercise, or diet changes.
  • Being deaf or blind: the study says it cannot meet these participants' needs because the video sessions rely on language and seeing exercises.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon/rectum, endometrium, esophagus, gallbladder, head/neck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed) * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions * CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder: \* Providing clinical care for participating patients on this study * CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English Exclusion Criteria: \-

Study sites (23)

CA

MA

  • Dana-Farber Cancer Institute · Boston, MA 02215Site Public Contact · Study contact · 877-442-3324Jennifer A. Ligibel · Principal investigatorMore trials in Boston

NC

PA