Feasibility of a Health Care Provider Guided Exercise Intervention Prior to Surgical Resection of Pancreatic Cancer

NYU Langone Health

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Behavioral: HCP-Guided Exercise Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05483075

22-00289

Details and patient eligibility

About

Pilot study evaluating the feasibility of a 2-4 week health care provider guided exercise intervention prior to surgery for pancreatic cancer.

Enrollment: 16 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willingness and ability to participate in the study procedures
2. Pathologically confirmed pancreatic cancer
3. Candidate for neoadjuvant therapy followed by surgical resection with potentially curative intent. Note: There is no limitation on duration of neoadjuvant therapy.
4. Planned to have at least 2 weeks after completing the last neoadjuvant therapy and surgery
5. Over the age of 18
6. Ability to engage in physical activity as determined by physiatrist review after completion of the Physical Activity Readiness questionnaire (PAR-Q) exercise survey and chart review
7. Agree to study blood draws and tissue collection

Exclusion criteria

1. Evidence of metastatic disease
2. Inability to complete physical activity due to recent injury or surgery
3. Uncontrolled heart disease limiting physical activity
4. Participation in another interventional trial that excludes participation in this protocol
5. Subjects who anticipate undergoing a procedure during the course of the trial that will render them unable to engage in physical activity for more than 48 hours
6. Pregnant subjects
7. Individuals who lack the capacity to consent

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

HCP-Guided Exercise

Experimental group

Description:

Participants will schedule twice-weekly in-person visits to conduct health care provider (HCP)-supervised exercise activity for a minimum of 30 minutes. At least 3 additional times per week, participants will conduct self-directed exercise at home. Activity and other outcomes will be monitored with an Actigraph Centrepoint Insight Watch. The HCP guided therapy will continue on a weekly basis for at least 2 weeks and up to a maximum of 4 weeks.

Treatment:

Behavioral: HCP-Guided Exercise Training Program

Control

No Intervention group

Description:

Participants will not participate in the HCP-guided exercise intervention but will wear the Actigraph Centrepoint Insight Watch.