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Localized Malignant Solid NeoplasmDEFENDNCT07059884

Distance-Based Exercise to Preserve Function and Prevent Disability

A study testing Exercise intervention, Telemedicine and Aerobic Exercise Intervention in people with Localized Malignant Solid Neoplasm and Anal Cancer, run by Alliance for Clinical Trials in Oncology at 23 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Exercise intervention, Telemedicine and Aerobic Exercise Intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
23 sitesUnited States
Study dates
11 Feb 2026to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • -

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lilli Johnson contact

773-834-4091

cancercontrolprotocols@alliancenctn.org

23 sites in 1 country

United States23 sites, 22 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Site Public Contact, 877-442-3324

    Jennifer A. Ligibel

    Recruiting

  • UPMC Hillman Cancer Center at Butler Health System

    Butler, Pennsylvania, 16001

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Kathryn Schmitz

    Recruiting

  • Kaiser Permanente Dublin

    Dublin, California, 94568

    Site Public Contact, 877-642-4691

    Jennifer M. Suga

    Recruiting

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Kaiser Permanente Fresno Orchard Plaza

    Fresno, California, 93720

    Site Public Contact, 833-574-2273

    Jennifer M. Suga

    Recruiting

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Kathryn Schmitz

    Recruiting

  • Novant Health Cancer Institute - Kernersville

    Kernersville, North Carolina, 27284

    Site Public Contact, 336-718-8335, asmarrs@novanthealth.org

    Judith O. Hopkins

    Recruiting

  • Kaiser Permanente- Modesto MOB II

    Modesto, California, 95356

    Site Public Contact, 877-642-4691

    Jennifer M. Suga

    Recruiting

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

    Suspended

  • Novant Health Cancer Institute - Mount Airy

    Mount Airy, North Carolina, 27030

    Site Public Contact, 336-718-8335, asmarrs@novanthealth.org

    Judith O. Hopkins

    Recruiting

  • UPMC Hillman Cancer Center - New Castle

    New Castle, Pennsylvania, 16105

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Kathryn Schmitz

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Kathryn Schmitz

    Recruiting

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Kaiser San Rafael-Gallinas

    San Rafael, California, 94903

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

    Site Public Contact, 814-676-7900

    Kathryn Schmitz

    Recruiting

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

    Site Public Contact, 336-718-8335, pjordan@novanthealth.org

    Judith O. Hopkins

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To establish the feasibility of implementing a virtual exercise intervention trial in a diverse cohort of cancer patients undergoing chemotherapy.

SECONDARY OBJECTIVE:

  1. To establish feasibility of enrolling and retaining a diverse patient population.

EXPLORATORY OBJECTIVES:

  1. Evaluate changes in 6 Minute Walk Test (6MWT) distance in the study population between baseline and the post-chemotherapy time point.

II. Evaluate changes in grip strength in the study population between baseline and the post-intervention time point.

III. 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.

IV. Explore the relationship between the predicted 6MWT and the baseline 6MWT. V. Explore changes in patient reported outcomes between baseline, end of intervention, and 3-months post intervention in the study population.

VI. Explore employment status over time in the study population.

VII. Explore differences intervention adherence and attrition by:

  1. Duration of chemotherapy regimen (12 weeks or less vs more than 12 weeks)
  2. Administration of chemotherapy in adjuvant vs neoadjuvant setting
  3. Administration of cytotoxic chemotherapy alone vs in combination with radiation
  4. Administration of cytotoxic chemotherapy alone vs in combination with immunotherapy or other targeted agent (monoclonal antibody, small molecule inhibitor, etc)

OUTLINE:

Patients complete supervised TH exercise sessions consisting of aerobic exercise over 20 minutes and progressive resistance exercise twice a week (BIW) and complete unsupervised aerobic exercise for a total of 50 minutes per week until the end of standard of care (SOC) chemotherapy or up to a total of 6 months, whichever comes first, in the absence of disease progression or unacceptable toxicity. Patients also receive a stationary bike, workbook, gloves, and resistance bands on study and wear an accelerometer throughout the study.

After completion of study intervention, patients are followed up at 4 weeks and 3 months.

Being tested
Exercise intervention, Telemedicine, Aerobic Exercise Intervention, Accelerometry, Questionnaire Administration
Medical subject headings
Anus Neoplasms, Neoplasms, Breast Neoplasms, Uterine Cervical Neoplasms, Colonic Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise interventionOther

    Complete supervised TH aerobic and progressive resistance exercise sessions

  • TelemedicineOther

    Also called Telehealth

    Complete supervised TH aerobic and progressive resistance exercise sessions

  • Aerobic Exercise InterventionOther

    Complete unsupervised aerobic exercise

  • Exercise InterventionOther

    Receive stationary bike, workbook, gloves, and resistance bands

  • AccelerometryProcedure or surgery

    Wear accelerometer

  • Questionnaire AdministrationOther

    Ancillary studies

  • InterviewOther

    Ancillary studies

  • Electronic Health Record ReviewOther

    Ancillary studies

Study groups in NCT07059884
Study groupRoleWhat they receive
Supportive care (DEFEND)ExperimentalPatients complete supervised TH exercise sessions consisting of progressive resistance exercise BIW and complete unsupervised aerobic exercise sessions over 30 minutes TIW until the end of SOC chemotherapy or up to a total of 6 months, whichever comes first, in the absence of disease progression or unacceptable toxicity. Patients also receive adjustable-weight dumbbells on study and wear an accelerometer throughout the study.
Receives: Other: Exercise intervention; Other: Telemedicine; Other: Aerobic Exercise Intervention; Procedure: Accelerometry; Other: Questionnaire Administration; Other: Interview; Other: Electronic Health Record Review

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of completed exercise sessions (Feasibility)

    Feasibility will be defined through intervention adherence. Will set a priori thresholds for this outcome to define success as detailed. For evaluating the uptake of the intervention, will assess the percentage of enrolled participants who complete at least 70% of prescribed exercise sessions. Will calculate the proportion of participants meeting this threshold and compare it to the predefined success criterion of 80%. Descriptive statistics (percentages) will be reported along with 95% confidence intervals.

    Measured: Up to 6 months

  2. Intervention attrition rate (Feasibility)

    Feasibility will be defined through intervention attrition. Will set a priori thresholds for this outcome to define success as detailed. To examine attrition from the trial, will calculate the attrition rate by dividing the number of participants who drop out of the trial by the total number of enrolled participants. The a priori acceptable attrition rate is no greater than 20%. Descriptive statistics (attrition rate) will be presented, and a comparison with the predefined threshold will be made.

    Measured: Up to 6 months

Secondary outcomes (2)

  1. Weekly recruitment rate

    Feasibility of enrolling a diverse patient population will be defined by: Enrolling 80 patients over a 58-week time period, from the date that the study is activated at all 4 enrolling sites and the first patient is enrolled. Descriptive statistics (mean, standard deviation) will be reported for weekly recruitment, along with graphical representations of recruitment trends over time.

    Measured: From the date that the study is activated at all 4 enrolling sites and the first patient is enrolled, assessed up to 58 weeks

  2. Retaining a diverse patient population

    Descriptive statistics (percentages) will be summarized for patients who meet at least one of the following criteria: Racial or ethnic minority status (African American, Hispanic, Native American, Pacific Islander), low socioeconomic status (defined as residing in an area in one of the top two quintiles of the Neighborhood Deprivation Index), residing in a rural area (Rural-Urban Continuum Codes or Rural-Urban Commuting Area Code, code 4-10).

    Measured: From the date that the study is activated at all 4 enrolling sites and the first patient is enrolled, assessed up to 58 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start11 Feb 2026
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07059884
Sponsor's protocol ID
A222302
Other IDs
NCI-2025-01495
Acronym
DEFEND
Status last verified
Oct 2026
First submitted
23 Jun 2025
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Exercise intervention, Telemedicine and Aerobic Exercise Intervention in people with Localized Malignant Solid Neoplasm and Anal Cancer, run by Alliance for Clinical Trials in Oncology at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lilli Johnson (773-834-4091, cancercontrolprotocols@alliancenctn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of completed exercise sessions (Feasibility) (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07059884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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