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