Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer surgery.
Elderly participants with epithelial ovarian cancer (EOC) and pancreatic adenocarcinoma (PDAC) undergoing neoadjuvant chemotherapy (NACT) are often frail and malnourished. Both chemotherapy and disease burden are associated with a decline in muscle mass leading to decrease in physical strength and cardiovascular fitness. Limited efforts have focused on decreasing morbidity at time of chemotherapy and surgery and improving functional capacity. Exercise during chemotherapy has been shown to improve chemotherapy related symptoms and quality of life in participants with breast cancer participants. In surgical patient populations, preoperative rehabilitation (prehabilitation) has been shown to improve walking capacity, decrease hospital length of stay, perioperative complications, and cost. However, whether multimodal prehabilitation improves the functional capacity and perioperative outcomes of EOC and PDAC participants undergoing NACT compared to standard of care is unknown. Investigators aim to evaluate if prehabilitation in participants with EOC and PDAC undergoing NACT improves physical fitness/ functional outcomes, perioperative outcomes, nutritional status, and quality of life compared to standard of care.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Arm 1 | Experimental | Exercise Intervention: Participants will be referred to Langston Hughes Community Center and work with exercise physiologists who will utilize our SmartGym ecosystem in providing exercise assessments, prescriptions, and training. Nitrition Intervention: Participants in the intervention group will be provided with 1-2 bottles of high protein oral nutritional supplements daily (ONS) to ensure that protein needs are met daily. There will be two options of ONS to choose from: one option a high calorie, high protein supplement, and the other option a low fat/low sugar, high protein supplement. Supportive care/Mind-body intervention: Participants will have access to Taussig Cancer Institute Patient Support services that are offered for free. |
|
| Control - Arm 2 | No Intervention | Exercise: Standard of care. Level of activity will be reported and monitored at each visit through study coordinator assessment and patient interview. Nutrition: Participants will be referred to dietitian and will be seen for a baseline evaluation, as needed throughout treatment and post treatment. A full nutrition assessment will be performed, and malnutrition diagnosis will be documented. When no malnutrition is identified participants will be provided general nutrition counseling related to their cancer type, cancer treatment, and recommendations for symptom management as needed. Those participants identified to be malnourished to any degree will receive personalized medical nutrition therapy including nutrition interventions to improve caloric intake. Supportive care/Mind-body intervention: Per standard of care, participants will be offered support services from Taussig Cancer Institute program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Other | Exercise Intervention: SmartGyms, band or smartphone used to scan into the TechnoGym MyWellness kiosk, which controls the TechnoGym Excite Live and Biostrength equipment. The exercise session will consist of a program that adheres to the FITT (Frequency, Intensity, Timing, and Type) exercise prescription in accordance with ACSM 2018 ACSM Roundtable recommendations for Physical Function for combined Aerobic and Resistance training. Nutrition Intervention: 30 gm protein supplement Supportive care/Mind-body intervention: Yoga, mindfulness practices, art therapy, and music therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adherence as calculated by the compliance percentage | Compliance will be defined as completion of at least 2 exercise sessions per week (75%) for the duration of the study. | 6 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test | Rep Max Isokinetic Strength Test measured by BiostrengthTM Maximal Strength | Baseline, 6 weeks post intervention |
| Change in effectiveness of prehabilitation as assessed by Grade Exercise Test Grade Exercise Test measured by Grade Exercise Test. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariam AlHilli, MD | Contact | 216-644-0418 | alhillm@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Mariam AlHilli, MD | Cleveland Clinic Foundation, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Recruiting | Cleveland | Ohio | 44195 | United States |
All IPD that underlie results in publication will be shared with scientific journals during peer-review or at scientific/medical conferences/meetings. All IDP will be anonymized.
The data will become available during the course of the study and indefinitely thereafter.
The data will be available as it pertains to journal publication to the scientific/medical community. This study has no intellectual property data that would require a CDA be in place.
Not provided
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
At baseline, and within the immediate post-exercise recovery, rating of perceived exertion (RPE; Borg scale, 6-20) will be assessed. Peak exercise exhaustion was verified if two or more of the following criteria were met: 1)96 HR within 10 bpm of age-predicted maximum HR (220-age), 2) RPE > 17, and/or 3) a plateau in HR (<3 bpm change over the last two intensity stages). VO2 max will be calculated by ACSM's Treadmill Walking Equation: VO2 [ml/kg/min] = (0.1 x speed) + (1.8 x Speed x Grade) 3.5 ml/kg/min |
| Baseline, 6 weeks post intervention |
| Change in effectiveness of prehabilitation as assessed by timed up and go test | Timed up and go test is one unit of time to measure how fast patients can move | Baseline, 6 weeks post intervention |
| Change in effectiveness of prehabilitation as assessed by grip strength test | Grip strength test measured by handheld dynamometer | Baseline, 6 weeks post intervention |
| Change in effectiveness of prehabilitation as assessed by 30 second sit to stand test | The number of times a patient can rise to a standing position from a seated position without the use of their upper extremities is counted in a thirty second period. | Baseline, 6 weeks post intervention |
| Change in measure of balance as assessed by unipedal stance test | This is a measure of balance and is assessed by asking the participant to stand on one foot (of their choice) with the lifted foot remaining close to their opposite ankle, first with eyes open and then with eyes closed.The amount of time a participant can stand on one foot is recorded. | Baseline, 6 weeks post intervention |
| Effectiveness of prehabilitation as assessed by measuring the change in body mass composition | Body composition measured using contrast-enhanced CT scan | Baseline, 6 weeks post-intervention |
| Effectiveness of prehabilitation as assessed by the change in nutritional status | Assessed for the presence of malnutrition per the Cleveland Clinic organization's standard of care based on American Society for Parenteral and Enteral Nutrition (ASPEN) and the Academy of Nutrition and Dietetics (AND) (ASPEN/AND) guidelines, and by assessing changes in the degree of malnutrition throughout the study period | Baseline, Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1(each cycle is 21 days) and 6 weeks post-intervention |
| Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy) | Functional Assessment of Cancer Therapy(FACT-G7) to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much' | At baseline |
| Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy) | Functional Assessment of Cancer Therapy(FACT-G7) to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much' | Up to 6 weeks post intervention |
| Quality of life as assessed by FACT-O | FACT-O to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much' | At baseline |
| Quality of life as assessed by FACT-O | FACT-O to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much' | Up to 6 weeks post intervention |
| Effectiveness of prehabilitation as assessed by Chemotherapy toxicity | Chemotherapy toxicity as measured by the standard CTCAE v5 grading system | At cycle 2, day 1(each cycle is 21 days) |
| Effectiveness of prehabilitation as assessed by Chemotherapy toxicity | Chemotherapy toxicity as measured by the standard CTCAE v5 grading system | At cycle 3, day 1(each cycle is 21 days) |
| Effectiveness of prehabilitation as assessed by Chemotherapy toxicity | Chemotherapy toxicity as measured by the standard CTCAE v5 grading system | At cycle 4, day 1(each cycle is 21 days) |
| Effectiveness of prehabilitation as assessed by Chemotherapy toxicity | Chemotherapy toxicity as measured by the standard CTCAE v5 grading system | Up to 6 weeks post intervention |
| Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using IAM(Intervention appropriateness measure) | IAM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree. | Up to 6 weeks post intervention |
| Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using FIM(Feasibility of intervention measure) | FIM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree. | Up to 6 weeks post intervention |
| Effectiveness of prehabilitation as assessed by participant acceptability scale | Participant acceptability of anxiety and depression screening as measured by Hospital anxiety and depression scale(HADS) scoring from 0-21 where 0-7 is normal;8-10 is borderline abnormal; 11-21 is abnormal | Baseline |
| Effectiveness of prehabilitation as assessed by participant acceptability scale | Participant acceptability of anxiety and depression screening as measured by Hospital anxiety and depression scale(HADS) scoring from 0-21 where 0-7 is normal;8-10 is borderline abnormal; 11-21 is abnormal | Up to 6 weeks post intervention |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |