Remote Resistance Exercise Powering Survivors – Gastrointestinal Oncology

Remote Resistance Exercise Powering Survivors – Gastrointestinal Oncology
  • 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

  • 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

  • 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 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 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 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 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 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 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) – 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.

  • 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.

  • 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 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 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 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 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.

  • 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.

  • 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.

  • Source: View full study details on ClinicalTrials.gov

    The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

    December 25, 2022Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
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