Recruiting NCT07030686
Association Between Exercise, Patient-Reported Outcomes, and Clinical Events in Adult Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Survivorship, Recurrent, Recurrence, Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Exercise
Exercise following completion of active treatment for the primary index cancer
Primary outcome measures
- Distant disease-free survival (DDFS) [Time frame: 5 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- City of Hope Cancer Center (Data Analysis Only) — Duarte
- University of California, Los Angeles (Data or Specimen Analysis Only) — Los Angeles
- Weill Cornell Medical College (Data or Specimen Analysis Only) — New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
Identifiers
NCT: NCT07030686 · 20-101