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Clinical Trials/NCT05921552
NCT05921552
Active, not recruiting
Not Applicable

Feasibility of Exercise Prehabilitation Among Older Patients With Hepatobiliary Cancer Planning for Surgery

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country25 target enrollmentJune 26, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatobiliary Cancer
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
25
Locations
1
Primary Endpoint
Percentage of Participants that Complete Study Assessments - Retention Feasibility
Status
Active, not recruiting
Last Updated
4 months ago

Overview

Brief Summary

The purpose of the study is to evaluate an exercise program for individuals with hepatobiliary cancer planning for surgery.

Registry
clinicaltrials.gov
Start Date
June 26, 2023
End Date
November 19, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Age ≥65 years
  • Resectable Hepatocellular carcinoma, Cholangiocarcinoma, or Liver metastasis with Liver resection planned ≥4 weeks
  • Able to sign consent

Exclusion Criteria

  • Does not meet inclusion criteria

Outcomes

Primary Outcomes

Percentage of Participants that Complete Study Assessments - Retention Feasibility

Time Frame: Up to 3 Months

Retention will be considered feasible if ≥70% of participants complete study measures

Participant Self-Reported Musculoskeletal Injuries - Safety

Time Frame: Up to 3 Months

The numerator of the safety variable will be the number of musculoskeletal injuries or adverse health events reported as "likely related" or "definitely related" the exercise programming and that caused at least some limitation of daily activity lasting more than 3 days. The denominator for the safety variable will be the number of exercise training sessions attended by the participant.

Objective Physical Functioning and Fitness

Time Frame: At Baseline and Up to 3 Months

Physical functioning and fitness will be assessed using the 30-second chair stand test,30-second arm curl test, and treadmill 6-minute walk test.

Percentage of Participants that Enroll and Consent - Enrollment Feasibility

Time Frame: Up to 12 Months

Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll

Adherence - Feasibility

Time Frame: Up to 3 Months

Adherence will be based on participants attending ≥ 70% of tele-RT sessions on average and performing ≥ 70% of prescribed moderate-intensity aerobic exercise per week

Exercise Training Safety

Time Frame: Up to 3 Months

Number of participants that reported any exercise-related musculoskeletal injuries or other adverse health events (e.g.,extreme fatigue, shortness of breath, heat-related illness, cardiovascular events, changes in medication) incurred over the course of the intervention.

Participant Evaluation of Feasibility and Acceptability - Acceptability

Time Frame: Up to 3 Months

Participants evaluation of feasibility and acceptability will be assessed with a questionnaire, adapted to fit the intervention. The questionnaire includes both Likert Scale and open-ended questions. An item-by-item basis and as average item score, with scores ≥4 ("agree" to "strongly agree") indicating acceptability. Open-ended responses will be analyzed qualitatively to inform intervention improvement.

Social Support

Time Frame: At Baseline and Up to 3 Months

Participants social support will be measured using two scales, the Multidimensional Scale of Perceived Social Support (a valid 12-item measure assessing perceived adequacy of general social support from friends, family, and significant others) and the Social Influence Scale for Exercise (positive influences) (a valid 15-item measure assessing perceived adequacy of exerciserelated social support from friends, family, and experts)

Participant Self Reported Exercise

Time Frame: At Baseline and Up to 3 Months

Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise

Participant Skeletal Muscle Index (SMI)

Time Frame: At Baseline and Up to 3 Months

Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans

Participants Health-Related Quality of Life

Time Frame: At Baseline and Up to 3 Months

Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey

Patient Activation

Time Frame: At Baseline and Up to 3 Months

Participants patient activation will be measured using the Patient Activation Measure Short Form that is a valid and reliable 13-item scale for measuring patient's self-reported knowledge, skill, and confidence for self-management.

Study Sites (1)

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