Survivors Uniting for Remote Guided Exercise

NCT07290309 | Recruiting DMC

• 2 other identifiers: 60021R01CA296965-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research study is to look at how live, online group exercise compares to recorded videos for helping increase physical activity levels, improve physical fitness and quality of life, and reduce loneliness among those living with and beyond cancer. The following aims have been established for this study:

• Aim 1: Examine the effect of a group-based videoconference physical activity (PA) intervention on moderate to vigorous physical activity \[MVPA\] (i.e., aerobic and resistance exercise).
• Aim 2: Examine the effect of the intervention on additional health-related outcomes including physical fitness (i.e., aerobic endurance, muscular strength), and quality of life at both timepoints.
• Aim 3: Explore potential mediators and moderators of intervention effects. We will examine mediators (e.g., self-efficacy, outcome expectations, group cohesion) and moderators (e.g., age, cancer stage, neighborhood walkability) of the intervention on MVPA.
• Exploratory Aim: Determine whether a group-based videoconference PA intervention reduces loneliness among cancer survivors. Researchers will randomize participants into one of two guided exercise groups that are 12-weeks long in duration. Participants will be asked to complete online fitness assessments and surveys as well as wear a physical activity monitor device and watch a few times throughout the study. The whole study is 9-months long in duration with a 6-month free-living period where no study activities will take place.

Conditions

Physical Activity; Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma); Physical Activity Behavior; Cancer (With or Without Metastasis); Cancer - Chronic Lymphocytic Leukemia; Cancer - Ovarian; Cancer

Keywords

Exercise oncology; Physical activity for cancer survivors; Group based exercise; Virtual exercise; physical activity; exercise; remote study; Cancer survivors

Outcome Measures

Primary Outcomes (2)

• Change in accelerometer measured moderate to vigorous physical activity from baseline to 3- and 6-month follow-up

  MVPA will be compared between the intervention and comparator arm from baseline to post-intervention (primary endpoint) and six-month follow-up.

  Assessed at baseline, 3-and 6-month follow-up

• Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 3 and 6 month follow-up

  Assessed by Godin Leisure Time Exercise Questionnaire (GLTEQ)

  Assessed at baseline, 3 and 6-month follow-up

Secondary Outcomes (2)

• Quality of life will be assessed by a quantitative self-report questionnaire

  Assessed at baseline and 3 and 6 month follow-up

• Physical fitness assessed by sit-to-stand and 2-minute step test

  Assessed at baseline and 3 and 6 month follow-up

Study Arms (2)

Intervention (Virtually Supervised Exercise Class)

EXPERIMENTAL

Live, group-based exercise classes will be delivered 2x per week on Zoom for 12-weeks along with a total of 5 behavior change discussion sessions.

Behavioral: Virtually Supervised Exercise Sessions

Comparator (Asynchronous Exercise Sessions)

ACTIVE COMPARATOR

Participants will watch pre-recorded exercise and discussion videos for 12-weeks.

Behavioral: Asynchronous Group

Interventions

Asynchronous Group BEHAVIORAL

The comparator will be an "unsupported intervention",128 which will use the same technology and provide the same content as the intervention but subtract the human components. Participants in the control group will receive access to pre-recorded (i.e., asynchronous) videos of the exercise and discussion sessions. The exercise videos will follow the same format as those in the intervention (i.e., instructor led, circuit-style aerobic and resistance exercises). Discussion sessions will operationalize the same BCT's using PowerPoint slides. Comparator arm participants will receive instructions on how to access these videos via a unique participant login to a secure website, Canvas, the same recommendations to achieve PA guidelines, and the same home-based exercise equipment (along with instructions for use).

Also known as: Pre-recorded exercise videos

Comparator (Asynchronous Exercise Sessions)

Virtually Supervised Exercise Sessions BEHAVIORAL

The 12-week intervention will consist of supervised exercise sessions twice per week, and PA behavior change discussion sessions twice per month (bi-weekly) throughout the study for a total of five sessions (Week 2, 4, 6, 8 and 10). Exercise and PA behavior change discussion sessions will be informed by social cognitive theory, operationalize several BCT's, and include group dynamics-based strategies to enhance group cohesion. Exercise sessions will take place twice per week, lasting approximately one hour.

Also known as: Live, Group-Based Zoom Class

Intervention (Virtually Supervised Exercise Class)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to speak/read English,
• Diagnosed with any type of cancer within the last 5 years
• Completed primary or adjuvant treatment (i.e., chemotherapy, radiation therapy, surgery) with no planned treatment within the next nine months. This does not include long-term or chronic therapies such as anti-hormone or targeted therapies (e.g., aromatase inhibitor, androgen deprivation therapy, immunotherapies)

You may not qualify if:

• Existing participation in ≥150 minutes per week of at least moderate intensity aerobic exercise
• Known contraindications for non-medically supervised moderate or greater intensity exercise (e.g., uncontrolled hypertension, inability to walk without an assistive device)
• Current or planned participation in another structured program or intervention intended to encourage participation in exercise or physical activity.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Colorado State University: lead

Study Sites (1)

Human Performance Clinical Research Lab

Fort Collins, Colorado, 80523, United States

RECRUITING

Related Links

• Study website where participants can learn more about the study and register interest

MeSH Terms

Conditions

Neoplasms; Colonic Neoplasms; Breast Neoplasms; Lymphoma; Multiple Myeloma; Motor Activity; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Behavior; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Heather J Leach, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather J Leach, PhD

CONTACT

(970) 491-8951; heather.leach@colostate.edu

Elena M Lancioni, MPH

CONTACT

elena.lancioni@colostate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: This study is a two-arm randomized controlled trial. Following the NIH Stage Model for Behavioral Intervention Development, we propose a stage II intervention, with the goal of traditional efficacy testing consisting of experimental testing in research settings, with research-based providers

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 18, 2025
• Study Start: February 6, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)