Association Between Exercise, Patient-Reported Outcomes, and Clinical Events in Adult Cancer Survivors

This protocol is a retrospective study using observational data to conduct a target trial emulation to examine the association of exercise on cancer specific endpoints and other clinical outcomes in cancer survivors.

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Cancer; Survivorship; Remission; Recurrent
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Jessica Scott, PhD; Phone Number: 646-888-8093; Email: scottj1@mskcc.org
• Study Contact Backup: Name: Chaya Moskowitz, PhD; Phone Number: 646-227-3607; Email: moskowc1@MSKCC.ORG

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Not yet recruiting
      • City of Hope Cancer Center (Data Analysis Only)
      • Contact: Lee Jones, PhD; Phone Number: 646-677-7440
    • Los Angeles, California, United States, 90095-1781
      • Not yet recruiting
      • University of California, Los Angeles (Data or Specimen Analysis Only)
      • Contact: Paul Boutros, PhD; Phone Number: 310-794-7160
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8093
    • New York, New York, United States, 10021
      • Not yet recruiting
      • Weill Cornell Medical College (Data or Specimen Analysis Only)
      • Contact: Xiaoyue Ma; Phone Number: 646-962-8029

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult (≥18 years of age) cancer survivors under surveillance at Memorial Sloan Kettering Cancer Center (MSK) between 2011 and 2023.

Description

Inclusion Criteria:

Target trial (ideal RCT)

• Adult (≥18 years of age) patients with history of primary invasive cancer under surveillance at Memorial Sloan Kettering Cancer Center (MSK).
• Completion of an exercise survey (baseline) as part of MSK Cancer Survivorship Program and completion of a historical survey in the MSK Cancer Survivorship Program 9-15 months (time th) prior reporting non-exercising status [i.e., reporting <10 metabolic equivalent-hours per week (MET-h/week)]. Patients completing an additional exercise survey between th and baseline are excluded.
• No evidence of recurrent or metastatic disease in the 15 months prior to the baseline exercise assessment
• Completion of all definitive primary adjuvant therapy (e.g., chemotherapy, radiotherapy, targeted therapy) at least 3 months prior to completion of the historical exercise survey in a MSK Cancer Survivorship Program. Adjuvant hormonal therapy is permitted at any time.
• Undergoing surveillance in the Cancer Survivorship Program at MSK

Emulation using observational data

• Adult (≥18 years of age) cancer survivors under surveillance at Memorial Sloan Kettering Cancer Center (MSK) between 2011 and 2023.
• Assessment of self-reported exercise status via completion of an exercise survey as part of MSK Cancer Survivorship Program standard intake (baseline assessment).
• Non-exercising (i.e., reporting <5 MET-h/week) via completion of an exercise survey as part of MSK Cancer Survivorship Program standard intake 9-15 months prior to the baseline exercise assessment (historical exercise survey).
• Documented history of the following absolute contraindications to moderate-intensity exercise at any time prior to the baseline exercise assessment, assessed using the Elixhauser ICD codes: Congestive heart failure, valvular disease, chronic pulmonary disease, or renal failure.
• No evidence of recurrent or metastatic disease via radiological or pathological in EMR in the 15 months prior to the baseline exercise assessment.
• Completion of all definitive primary adjuvant therapy (e.g., chemotherapy, radiotherapy, targeted therapy) at least 3 months prior to completion of historical exercise survey (i.e., at least 3 months prior to t-1) as part of MSK Cancer Survivorship Program standard intake. Adjuvant endocrine therapy is permitted.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1: Usual Care
Arm 2: Exercise	Behavioral: Exercise; Exercise following completion of active treatment for the primary index cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant disease-free survival (DDFS)	To estimate the association of exercise vs. usual care (control) with Distant disease-free survival (DDFS) among patients following the completion of active treatment for the primary index cancer being monitored at MSK.	5 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Jessica Scott, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2020
• Primary Completion (Estimated): March 19, 2027
• Study Completion (Estimated): March 19, 2027

Study Registration Dates

• First Submitted: June 12, 2025
• First Submitted That Met QC Criteria: June 12, 2025
• First Posted (Actual): June 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; cancer survivor; Memorial Sloan Kettering Cancer Center; Survivorship; no evidence of disease; adult cancer survivor; 20-101
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Behavior; Neoplasms; Recurrence; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 20-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No