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Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology

Primary Purpose

Gastrointestinal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-Resistance 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 Gastrointestinal Cancer focused on measuring Gastrointestinal Cancer, Remote Resistance Exercise, GI Cancer Stage III, GI Cancer Stage IV, Tele-Resistance Training

Eligibility Criteria

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

Inclusion Criteria: Age ≥ 18 years Biopsy-proven upper GI cancer, stage III-IV ECOG performance status 0-1 Treatment plan of chemotherapy with planned return to Moffitt Cancer Center for restaging Able to read and speak English fluently Capable of providing informed consent Exclusion Criteria: Regular engagement in RT (2x/week targeting all major muscle groups) Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and Patient-Reported Measurement Information System (PROMIS) screening questions Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV). Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT Numeric pain rating scale of ≥ 7 out of 10 Myopathic or rheumatologic disease that impacts physical function

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tele-Resistance Training (RT)

Usual Care (UC)

Arm Description

Participants will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week for 12 weeks. Participants will also be encouraged to perform moderate aerobic exercise at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.

Participants randomized to the Usual Care (UC) arm will be provided with information materials outlining resistance training using body weight or basic equipment. 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 ≥ 70% 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 who complete baseline measures also complete followup measures
Exercise Adherence - Feasibility
Exercise adherence will be assessed based on performance of prescribed exercise volume, with tele-RT volumes considered feasible if participants perform ≥ 70% of the volume prescribed.
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.
Participant Self-Reported Musculoskeletal Injuries - Safety
Participants will be asked to report the following information: type (joint or soft tissue or other), location (specific body part), and cause (description of activity during which injury was incurred). Participants will then rate the injury on a scale of 1-4 (1=not related, 2=unlikely related, 3=likely related, 4=definitely related). The severity of the injury will be rated on a scale of 1-4 (1=mild/no change in daily activity, 2=some limitation of daily activity, 3=major limitation of daily activity, 4=life threatening). The duration for which daily activities were impacted will be rated on a scale from 1-5 (1=no change, 2=1-3 days, 3=4-7 days, 4=1-2 weeks, 5=more than 2 weeks). The numerator of the variable used to determine program safety will be the number of musculoskeletal injuries that were rated at least a 3 for relatedness to RT (likely related or definitely related) and caused at least some limitation of daily activity lasting more than 3 days.
Participant Muscular Strength - Baseline
Muscular strength will be measured using four separate 1-repetition maximum (1RM) lifts: chest press, seated row, leg press, and leg extension performed on resistance training machines. If a particular 1RM lift is contraindicated for a given participant (e.g., limited range of motion for a given joint or osteoporosis), the lift will be skipped, or 5-repetition maximum (5RM) will be measured instead of 1RM, and 1RM will be estimated from 5RM.
Participant Muscular Strength - Follow-up
Muscular strength will be measured using four separate 1-repetition maximum (1RM) lifts: chest press, seated row, leg press, and leg extension performed on resistance training machines. If a particular 1RM lift is contraindicated for a given participant (e.g., limited range of motion for a given joint or osteoporosis), the lift will be skipped, or 5-repetition maximum (5RM) will be measured instead of 1RM, and 1RM will be estimated from 5RM.
Participant Muscular Endurance - Baseline
Muscular endurance will be measured by the maximum number of repetitions a participant can perform at 70% of the baseline 1-repetition maximum (1RM) for the same four lifts
Participant Muscular Endurance - Follow-up
Muscular endurance will be measured by the maximum number of repetitions a participant can perform at 70% of the baseline 1-repetition maximum (1RM) for the same four lifts
Participant Skeletal Muscle Index (SMI) - Baseline
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participant Skeletal Muscle Index (SMI) - Follow-up
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participant Skeletal Muscle Density (SMD) - Baseline
Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participant Skeletal Muscle Density (SMD) - Follow-up
Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participants Health-Related Quality of Life
Health-related quality of life will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G)
Participant Fatigue
Participant fatigue will be measured using the FACT-Fatigue questionnaire (FACT-F)
Participant Physical Functioning
Participants physical functioning will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form
Participant Chemotherapy-induced peripheral neuropathy (CIPN)
Participant CIPN will be measured using the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)
Participant Self Reported Exercise - Baseline
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Self Reported Exercise - Follow-up
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Clinicodemographic Characteristics - Baseline
Participant clinicodemographic characteristics including tumor type and cancer stage, chemotherapy type, sex, age, body mass index, race/ethnicity, and marital status will be collected from participants' electronic medical records.
Participant Clinicodemographic Characteristics - Follow-up
Participant clinicodemographic characteristics including tumor type and cancer stage, chemotherapy type, sex, age, body mass index, race/ethnicity, and marital status will be collected from participants' electronic medical records.
Participant Treatment Outcome
Participant relevant treatment outcomes including chemotherapy dose reductions and changes in chemotherapy will be collected from participants' electronic medical records.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2022
Last Updated
October 17, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05664178
Brief Title
Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology
Official Title
Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology (Remote REPS - GI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)

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 a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
Keywords
Gastrointestinal Cancer, Remote Resistance Exercise, GI Cancer Stage III, GI Cancer Stage IV, Tele-Resistance Training

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-Resistance Training (RT)
Arm Type
Experimental
Arm Description
Participants will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week for 12 weeks. Participants will also be encouraged to perform moderate aerobic exercise at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.
Arm Title
Usual Care (UC)
Arm Type
No Intervention
Arm Description
Participants randomized to the Usual Care (UC) arm will be provided with information materials outlining resistance training using body weight or basic equipment. Participants will wear a FitBit fitness watch to monitor aerobic exercise.
Intervention Type
Behavioral
Intervention Name(s)
Tele-Resistance Training
Intervention Description
Tele-Resistance training sessions will be supervised and guided by a certified exercise trainer via smartphone, tablet or laptop. Exercises will be performed using resistance tubes (Bodylastics Resistance Bands Set) and a connectable bar (Bionic Body Workout Bar) that mimics a weighted barbell when tubes are attached. The tubes provide up to 142 pounds of resistance (adjustable in increments between 3-10 pounds) when simultaneously connected to handles or bar, and multiple tubes can be attached simultaneously. Participants will engage in brief warm up exercises lasting 2-3 minutes prior to each RT session and will rest at least 1 minute between sets of the same exercise to aid muscle recovery. Participants will perform at least 2 sets of 12 repetitions for each of 6 exercises. Including warm up, training sets, and rest, sessions will last approximately 30 minutes. RT will include six target exercises focusing on major muscle groups of the upper body, lower body, and core.
Primary Outcome Measure Information:
Title
Percentage of Participants that Enroll and Consent - Enrollment Feasibility
Description
Enrollment will be considered feasible if ≥ 70% of eligible and approached patients actually consent and enroll
Time Frame
Up to 36 Months
Title
Percentage of Participants that Complete Study Assessments - Retention Feasibility
Description
Retention will be considered feasible if ≥ 70% of participants who complete baseline measures also complete followup measures
Time Frame
Up to 3 Months
Title
Exercise Adherence - Feasibility
Description
Exercise adherence will be assessed based on performance of prescribed exercise volume, with tele-RT volumes considered feasible if participants perform ≥ 70% of the volume prescribed.
Time Frame
Up to 6 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 6 Months
Title
Participant Self-Reported Musculoskeletal Injuries - Safety
Description
Participants will be asked to report the following information: type (joint or soft tissue or other), location (specific body part), and cause (description of activity during which injury was incurred). Participants will then rate the injury on a scale of 1-4 (1=not related, 2=unlikely related, 3=likely related, 4=definitely related). The severity of the injury will be rated on a scale of 1-4 (1=mild/no change in daily activity, 2=some limitation of daily activity, 3=major limitation of daily activity, 4=life threatening). The duration for which daily activities were impacted will be rated on a scale from 1-5 (1=no change, 2=1-3 days, 3=4-7 days, 4=1-2 weeks, 5=more than 2 weeks). The numerator of the variable used to determine program safety will be the number of musculoskeletal injuries that were rated at least a 3 for relatedness to RT (likely related or definitely related) and caused at least some limitation of daily activity lasting more than 3 days.
Time Frame
Up to 6 Months
Title
Participant Muscular Strength - Baseline
Description
Muscular strength will be measured using four separate 1-repetition maximum (1RM) lifts: chest press, seated row, leg press, and leg extension performed on resistance training machines. If a particular 1RM lift is contraindicated for a given participant (e.g., limited range of motion for a given joint or osteoporosis), the lift will be skipped, or 5-repetition maximum (5RM) will be measured instead of 1RM, and 1RM will be estimated from 5RM.
Time Frame
At Baseline
Title
Participant Muscular Strength - Follow-up
Description
Muscular strength will be measured using four separate 1-repetition maximum (1RM) lifts: chest press, seated row, leg press, and leg extension performed on resistance training machines. If a particular 1RM lift is contraindicated for a given participant (e.g., limited range of motion for a given joint or osteoporosis), the lift will be skipped, or 5-repetition maximum (5RM) will be measured instead of 1RM, and 1RM will be estimated from 5RM.
Time Frame
Up to 6 Months
Title
Participant Muscular Endurance - Baseline
Description
Muscular endurance will be measured by the maximum number of repetitions a participant can perform at 70% of the baseline 1-repetition maximum (1RM) for the same four lifts
Time Frame
At Baseline
Title
Participant Muscular Endurance - Follow-up
Description
Muscular endurance will be measured by the maximum number of repetitions a participant can perform at 70% of the baseline 1-repetition maximum (1RM) for the same four lifts
Time Frame
Up to 6 Months
Title
Participant Skeletal Muscle Index (SMI) - Baseline
Description
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Time Frame
At Baseline
Title
Participant Skeletal Muscle Index (SMI) - Follow-up
Description
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Time Frame
Up to 6 Months
Title
Participant Skeletal Muscle Density (SMD) - Baseline
Description
Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Time Frame
At Baseline
Title
Participant Skeletal Muscle Density (SMD) - Follow-up
Description
Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Time Frame
Up to 6 Months
Title
Participants Health-Related Quality of Life
Description
Health-related quality of life will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G)
Time Frame
Up to 6 Months
Title
Participant Fatigue
Description
Participant fatigue will be measured using the FACT-Fatigue questionnaire (FACT-F)
Time Frame
Up to 6 Months
Title
Participant Physical Functioning
Description
Participants physical functioning will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form
Time Frame
Up to 6 Months
Title
Participant Chemotherapy-induced peripheral neuropathy (CIPN)
Description
Participant CIPN will be measured using the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)
Time Frame
Up to 6 Months
Title
Participant Self Reported Exercise - Baseline
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
Title
Participant Self Reported Exercise - Follow-up
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
Up to 6 Months
Title
Participant Clinicodemographic Characteristics - Baseline
Description
Participant clinicodemographic characteristics including tumor type and cancer stage, chemotherapy type, sex, age, body mass index, race/ethnicity, and marital status will be collected from participants' electronic medical records.
Time Frame
At Baseline
Title
Participant Clinicodemographic Characteristics - Follow-up
Description
Participant clinicodemographic characteristics including tumor type and cancer stage, chemotherapy type, sex, age, body mass index, race/ethnicity, and marital status will be collected from participants' electronic medical records.
Time Frame
Up to 6 Months
Title
Participant Treatment Outcome
Description
Participant relevant treatment outcomes including chemotherapy dose reductions and changes in chemotherapy will be collected from participants' electronic medical records.
Time Frame
Up to 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Biopsy-proven upper GI cancer, stage III-IV ECOG performance status 0-1 Treatment plan of chemotherapy with planned return to Moffitt Cancer Center for restaging Able to read and speak English fluently Capable of providing informed consent Exclusion Criteria: Regular engagement in RT (2x/week targeting all major muscle groups) Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and Patient-Reported Measurement Information System (PROMIS) screening questions Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV). Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT Numeric pain rating scale of ≥ 7 out of 10 Myopathic or rheumatologic disease that impacts physical function
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan Parker, PhD, MPH
Phone
813-745-0527
Email
Nathan.Parker@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Parker, PhD, MPH
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
Nathan Parker, PhD, MPH
Phone
813-745-0527
Email
Nathan.Parker@moffitt.org
First Name & Middle Initial & Last Name & Degree
Nathan Parker, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Martine Extermann, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rutika Mehta, MD, MPH
First Name & Middle Initial & Last Name & Degree
Pamela Hodul, MD
First Name & Middle Initial & Last Name & Degree
Jose Pimiento, MD
First Name & Middle Initial & Last Name & Degree
Richard Kim, MD
First Name & Middle Initial & Last Name & Degree
Dae Won Kim, MD
First Name & Middle Initial & Last Name & Degree
Mohammed Al-Jumayli, MD
First Name & Middle Initial & Last Name & Degree
Daniel Anaya Saenz, MD
First Name & Middle Initial & Last Name & Degree
Jason Denbo, MD
First Name & Middle Initial & Last Name & Degree
Sean Dineen, MD
First Name & Middle Initial & Last Name & Degree
Andrew Sinnamon, MD
First Name & Middle Initial & Last Name & Degree
Jason Fleming, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=21742
Description
Moffitt Cancer Center Clinical Trials Search

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Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology

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