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Senior Adult Hepatobiliary Prehab Study

Primary Purpose

Hepatobiliary Cancer, Cholangiocarcinoma, Liver Metastases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Training
Aerobic Training
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hepatobiliary Cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥70 years Resectable Hepatocellular carcinoma, Cholangiocarcinoma, or Liver metastasis with Liver resection planned ≥4 weeks ECOG 0-2 Able to sign consent Exclusion Criteria: Does not meet inclusion criteria

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tele Health Exercise Prehabilitation

Arm Description

Participants will take part in an exercise program in which they will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week until they undergo surgery (Approximately 2-4 weeks). Participants will also be encouraged to perform moderate aerobic exercise such as brisk walking or using stationary aerobic equipment at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.

Outcomes

Primary Outcome Measures

Percentage of Participants that Enroll and Consent - Enrollment Feasibility
Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll
Percentage of Participants that Complete Study Assessments - Retention Feasibility
Retention will be considered feasible if ≥70% of participants complete study measures
Adherence - Feasibility
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
Participant Self-Reported Musculoskeletal Injuries - Safety
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.
Exercise Training Safety
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
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.
Objective Physical Functioning and Fitness
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.
Participant Skeletal Muscle Index (SMI)
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Participants Health-Related Quality of Life
Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Patient Activation
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.
Social Support
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
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise

Secondary Outcome Measures

Full Information

First Posted
June 16, 2023
Last Updated
June 16, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05921552
Brief Title
Senior Adult Hepatobiliary Prehab Study
Official Title
Feasibility of Exercise Prehabilitation Among Older Patients With Hepatobiliary Cancer Planning for Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatobiliary Cancer, Cholangiocarcinoma, Liver Metastases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele Health Exercise Prehabilitation
Arm Type
Experimental
Arm Description
Participants will take part in an exercise program in which they will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week until they undergo surgery (Approximately 2-4 weeks). Participants will also be encouraged to perform moderate aerobic exercise such as brisk walking or using stationary aerobic equipment at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training
Intervention Description
Participants will be encouraged to perform approximately 30 minutes of resistance training exercises twice per week, until they undergo surgery. Exercises will be performed using resistance tubes (Bodylastics Inc) and the included accessories (handles and anchor straps) to perform resistance exercises. During Zoom sessions, certified exercise trainers will guide participants to utilize equipment to perform resistance exercises with proper form. Each groups resistance training session will span approximately 1 hour, including a brief warm-up, stretching, and 2 sets of ≥12 repetitions for each of 5 exercises: single arm chest press, single arm row, lateral raise, squat (or chair stand), and resistance tube deadlift.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Training
Intervention Description
Participants will be encouraged to perform ≥30 minutes of moderate-intensity aerobic exercise on ≥3 days per week. Aerobic exercise intensity will be guided by heart rate zones, with participants exercising at 50-70% of their age-predicted maximum heart rate in bouts of at least 10 minutes at a time. Participants will be encouraged to gradually increase exercise intensity and duration until they are meeting the recommendation
Primary Outcome Measure Information:
Title
Percentage of Participants that Enroll and Consent - Enrollment Feasibility
Description
Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll
Time Frame
Up to 12 Months
Title
Percentage of Participants that Complete Study Assessments - Retention Feasibility
Description
Retention will be considered feasible if ≥70% of participants complete study measures
Time Frame
Up to 3 Months
Title
Adherence - Feasibility
Description
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
Time Frame
Up to 3 Months
Title
Participant Self-Reported Musculoskeletal Injuries - Safety
Description
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.
Time Frame
Up to 3 Months
Title
Exercise Training Safety
Description
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.
Time Frame
Up to 3 Months
Title
Participant Evaluation of Feasibility and Acceptability - Acceptability
Description
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.
Time Frame
Up to 3 Months
Title
Objective Physical Functioning and Fitness
Description
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.
Time Frame
At Baseline and Up to 3 Months
Title
Participant Skeletal Muscle Index (SMI)
Description
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Time Frame
At Baseline and Up to 3 Months
Title
Participants Health-Related Quality of Life
Description
Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Time Frame
At Baseline and Up to 3 Months
Title
Patient Activation
Description
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.
Time Frame
At Baseline and Up to 3 Months
Title
Social Support
Description
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)
Time Frame
At Baseline and Up to 3 Months
Title
Participant Self Reported Exercise
Description
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Time Frame
At Baseline and Up to 3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥70 years Resectable Hepatocellular carcinoma, Cholangiocarcinoma, or Liver metastasis with Liver resection planned ≥4 weeks ECOG 0-2 Able to sign consent Exclusion Criteria: Does not meet inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Al-Jumayli, MD
Phone
813-745-8658
Email
Mohammed.AlJumayli@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Al-Jumayli, MD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Morganti
Phone
813-745-1848
Email
Ashley.Morganti@moffitt.org
First Name & Middle Initial & Last Name & Degree
Mohammed Al-Jumayli, MD
First Name & Middle Initial & Last Name & Degree
Nathan Parker, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Daniel Anaya Saenz, MD
First Name & Middle Initial & Last Name & Degree
Kea Turner, PhD
First Name & Middle Initial & Last Name & Degree
Martine Extermann, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.moffitt.org/clinicaltrialssearch/?diseasesite=&query=22153&studytype=&medication=&therapy=&pi=&nct=&sortcriteria=
Description
Moffitt Clinical Trial Search

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Senior Adult Hepatobiliary Prehab Study

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