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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Remission; Survivorship; Recurrent; Cancer; Recurrence

Treatments: Behavioral: Exercise

Study type: Observational

Funder types: Other

Identifiers

NCT07030686

20-101

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

1,000 participants in 2 patient groups

Arm 1: Usual Care

Arm 2: Exercise

Treatment:

Behavioral: Exercise