Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology (Remote REPS - GI)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Gastrointestinal Cancer
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Percentage of Participants that Enroll and Consent - Enrollment Feasibility
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Percentage of Participants that Enroll and Consent - Enrollment Feasibility
Time Frame: Up to 36 Months
Enrollment will be considered feasible if ≥ 70% of eligible and approached patients actually consent and enroll
Participant Muscular Strength - Baseline
Time Frame: At 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 Clinicodemographic Characteristics - Follow-up
Time Frame: Up to 6 Months
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.
Exercise Adherence - Feasibility
Time Frame: Up to 6 Months
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 Self-Reported Musculoskeletal Injuries - Safety
Time Frame: Up to 6 Months
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 Endurance - Follow-up
Time Frame: Up to 6 Months
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
Time Frame: At 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
Time Frame: Up to 6 Months
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) - Follow-up
Time Frame: Up to 6 Months
Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participant Muscular Strength - Follow-up
Time Frame: Up to 6 Months
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 Self Reported Exercise - Baseline
Time Frame: At 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
Time Frame: Up to 6 Months
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Treatment Outcome
Time Frame: Up to 6 Months
Participant relevant treatment outcomes including chemotherapy dose reductions and changes in chemotherapy will be collected from participants' electronic medical records.
Percentage of Participants that Complete Study Assessments - Retention Feasibility
Time Frame: Up to 3 Months
Retention will be considered feasible if ≥ 70% of participants who complete baseline measures also complete followup measures
Participant Skeletal Muscle Density (SMD) - Baseline
Time Frame: At Baseline
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
Time Frame: Up to 6 Months
Health-related quality of life will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G)
Participant Fatigue
Time Frame: Up to 6 Months
Participant fatigue will be measured using the FACT-Fatigue questionnaire (FACT-F)
Participant Chemotherapy-induced peripheral neuropathy (CIPN)
Time Frame: Up to 6 Months
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 Evaluation of Feasibility and Acceptability - Acceptability
Time Frame: Up to 6 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.
Participant Muscular Endurance - Baseline
Time Frame: At 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 Physical Functioning
Time Frame: Up to 6 Months
Participants physical functioning will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form
Participant Clinicodemographic Characteristics - Baseline
Time Frame: At 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.