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क्लिनिकल ट्रायल NCT06196008 के लिए फेफड़े का कार्सिनोमा वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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कार्ड दृश्य
खोज पर वापस जाएँ

Telephone-based Physical Activity Coaching or Self Monitored Physical Activity to Improve Physical Function in Older Adults Who Are Undergoing Surgery for Lung Cancer and Their Caregivers

भर्ती जारी
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT06196008 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो फेफड़े का कार्सिनोमा से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 5 दिसंबर 2023 को हुई थी, और इसमें कुल 382 प्रतिभागियों के नामांकन की योजना है। सिटी ऑफ़ होप मेडिकल सेंटर इस परीक्षण का नेतृत्व कर रहे हैं और इसके 16 मई 2028 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 16 सितंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This clinical trial compares telephone-based physical activity coaching to self monitored physical activity for improving physical function in older adults who are undergoing surgery for lung cancer and their caregivers. Lung cancer surgery in older adults is associated with functional declines and unique challenges. Performing physical activity around the time of surgery has been shown to improve functional outcomes in patients and exercise programs delivered via telehealth may improve access and convenience for patients and minimize participant burden. Telephone-based physical activity coaching may improve physical functioning for older adults with lung cancer who are undergoing surgery.
विस्तृत विवरण
PRIMARY OBJECTIVE:

I. To compare changes from baseline in objective patient functional capacity as measured by 6 minute walk test (6MWT) at day 30 post-discharge between the two comparators.

SECONDARY OBJECTIVES:

I. To compare the following outcomes between the two comparators:

Ia. 6MWT at 60 and 180 days post discharge; Ib. Short Physical Performance Battery (SPPB) at 30, 60, and 180 days post-discharge; Ic. The following scores at 30, 60, and 180 days post-discharge: a) patient and family caregiver (FCG) reported self-efficacy; b) patient and FCG reported physical function; c) and patient and FCG quality of life (QOL); Id. Patient time at home and away from the hospital through 60 days post-discharge; Ie. Hospital readmissions rate and postoperative complications through 60 days post-discharge.

EXPLORATORY OBJECTIVES:

I. To explore associations between comparators, outcomes, and the following:

Ia. Perioperative, image-based sarcopenia using standard-of care preoperative chest computed tomography (CT) scans; Ib. Pedometer documented daily steps; Ic. Participant demographic and clinical characteristics.

OUTLINE: Patients and their FCG are randomized together to 1 of 2 arms.

ARM I: Patients attend telephone-based coaching sessions over 20-50 minutes once 7-14 days before standard of care surgery, and then at days 7, 14, 21, and 51 post-discharge, for a total of 5 sessions. Patients also receive a personalized physical activity program and set fitness goals. FCGs also receive coaching and serve as a walking buddy for their patient. Patients and FCGs also wear an activity monitor throughout the trial.

ARM II: Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.

After completion of study intervention, patients are followed up at days 60 and 180 post-discharge.

आधिकारिक शीर्षक

SR2204: A Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults With Lung Cancer and Their Family Caregivers

चिकित्सीय स्थितियाँ
फेफड़े का कार्सिनोमा
प्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:
अन्य अध्ययन आईडी
NCT नंबर
NCT06196008
अध्ययन प्रारंभ तिथि (वास्तविक)
2023-12-05
अंतिम अद्यतन प्रकाशित
2025-09-16
अध्ययन की समाप्ति तिथि (अनुमानित)
2028-05-16
नामांकन (अनुमानित)
382
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्राथमिक उद्देश्य
सहायक देखभाल
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुलें लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/हाथहस्तक्षेप/इलाज
प्रयोगात्मकArm I (Telephone-based coaching session)
Patients attend telephone-based coaching sessions over 20-50 minutes once 7-14 days before standard of care surgery, and then at days 7, 14, 21, and 51 post-discharge, for a total of 5 sessions. Patients also receive a personalized physical activity program and set fitness goals. FCGs also receive coaching and serve as a walking buddy for their patient. Patients and FCGs also wear an activity monitor throughout the trial.
शैक्षिक हस्तक्षेप
Attend telephone-based coaching sessions
व्यायाम हस्तक्षेप
Receive a personalized physical activity program, set fitness goals
चिकित्सकीय उपकरण का उपयोग और मूल्यांकन
Wear activity monitor
शारीरिक प्रदर्शन परीक्षण
Ancillary studies
जीवन की गुणवत्ता का मूल्यांकन
Ancillary studies
प्रश्नावली प्रशासन
Ancillary studies
सक्रिय तुलना समूहArm II (Written education)
Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.
शैक्षिक हस्तक्षेप
Receive written educational materials on physical activity and standard preoperative care
चिकित्सकीय उपकरण का उपयोग और मूल्यांकन
Wear activity monitor
शारीरिक प्रदर्शन परीक्षण
Ancillary studies
जीवन की गुणवत्ता का मूल्यांकन
Ancillary studies
प्रश्नावली प्रशासन
Ancillary studies
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Objective patient functional capacity
Measured by the 6 minute walk test (6MWT). Analysis will be a study group comparison via linear regression model.
At 30 days post discharge
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Functional capacity
Measured by 6MWT. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
At 60 and 180 days post discharge
Lower extremity function
Measured by the short physical performance battery. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
At 30, 60 and 180 days post discharge
Patient and caregiver reported self efficacy
Measured by patient reported outcomes measurement information system (PROMIS) self efficacy. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
At 30, 60, and 180 days post discharge
Patient and caregiver reported physical function
Measured by PROMIS physical function. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
At 30, 60 and 180 days post discharge
Patient reported quality of life
Measured by Functional Assessment of Cancer Therapy -Lung for patients. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
At 30, 60 and 180 days post discharge
Caregiver reported quality of life
Measured by City of Hope-Quality of Life-Family Caregiver for caregivers. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
At 30, 60 and 180 days post discharge
Patient time at home and away from the hospital
Will be compared by study arm by linear regression models.
Up to 60 days post discharge
Hospital readmissions
Will be compared by study arm via logistic regression.
Up to 60 days post discharge
Postoperative complications
Will be compared by study arm via logistic regression.
Up to 60 days post discharge
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
स्वस्थ स्वयंसेवकों को स्वीकार करता है
हाँ

  • PATIENT: Documented informed consent of the participant and/or legally authorized representative

  • PATIENT: Agreement to allow the use of preoperative chest CT scan for exploratory analysis, if available

  • PATIENT: Agreement to wear pedometer during study duration

    • If unwilling, exceptions may be granted with study primary investigator (PI) approval

  • PATIENT: Age >= 65 years

  • PATIENT: Ability to read and understand English or Spanish and willingness to complete participant-reported outcomes and assessments

  • PATIENT: Diagnosis of lung cancer or presumed lung cancer (as determined by surgeons) in patient

  • PATIENT: Scheduled to undergo lung surgery for lung cancer or suspected lung cancer with curative intent (neoadjuvant therapy allowed)

  • PATIENT: Adults lacking capacity to consent in the opinion of the attending surgeon will not be enrolled

  • FCG: Documented informed consent of the participant and/or legally authorized representative

  • FCG: Age >= 18

  • FCG: Ability to read and understand English or Spanish and willingness to complete participant-reported outcomes and assessments

  • FCG: Adults lacking capacity to consent in the opinion of the attending surgeon will not be enrolled

  • PATIENT: Lung surgery is scheduled in less than 14 calendar days from the time of registration
  • PATIENT: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including exercise program and compliance issues related to feasibility/logistics)
  • FCG: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including exercise program and compliance issues related to feasibility/logistics)
City of Hope Medical Center logoसिटी ऑफ़ होप मेडिकल सेंटर344 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिए
National Cancer Institute (NCI) logoराष्ट्रीय कैंसर संस्थान, अमेरिका3028 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिए
अध्ययन केंद्रीय संपर्क
संपर्क: Dan Raz, MD, 626-471-7100, [email protected]
13 1 देशों में अध्ययन स्थल

California

University of California, Davis, California, 95616, United States
Lisa Brown, MD, संपर्क, 916-734-3861, [email protected]
Lisa Brown, MD, मुख्य अन्वेषक
अभी भर्ती शुरू नहीं
City of Hope Medical Center, Duarte, California, 91010, United States
Dan Raz, संपर्क, 626-471-7100, [email protected]
Dan Raz, मुख्य अन्वेषक
भर्ती जारी
Standard University, Stanford, California, 94305, United States
Natalie Lui, MD, संपर्क, 415-378-1406, [email protected]
Natalie Lui, MD, मुख्य अन्वेषक
भर्ती जारी
Standford University, Stanford, California, 94305, United States
Natalie Lui, MD, संपर्क, 415-378-1406, natalielui@[email protected]
Natalie Lui, MD, मुख्य अन्वेषक
अभी भर्ती शुरू नहीं

Connecticut

Yale New Haven Medical Center, New Haven, Connecticut, 06510, United States
Justin Blasberg, MD, संपर्क, 646-251-2670, [email protected]
Justin Blasberg, MD, मुख्य अन्वेषक
भर्ती जारी

Florida

Moffitt Cancer Center, Tampa, Florida, 33612, United States
Eric Toloza, MD, PhD, संपर्क, 813-745-7282, [email protected]
Eric Toloza, MD, PhD, मुख्य अन्वेषक
भर्ती जारी

Illinois

Northwestern University, Evanston, Illinois, 60208, United States
Samuel Kim, MD, संपर्क, 312-694-6469, [email protected]
Samuel Kim, MD, मुख्य अन्वेषक
अभी भर्ती शुरू नहीं

Massachusetts

Massachusetts General Hospital (MGH) / Harvard, Boston, Massachusetts, 02114, United States
Chi-Fu J. Yang, MD, संपर्क, 617-726-6826, [email protected]
Chi-Fu J. Yang, MD, मुख्य अन्वेषक
भर्ती जारी

Mississippi

University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States
Jacob Moremen, MD, संपर्क, 601-984-5170, [email protected]
Jacob Moremen, MD, मुख्य अन्वेषक
भर्ती जारी

North Carolina

Duke University, Durham, North Carolina, 27710, United States
Betty Tong, MD, संपर्क, 919-613-4690, [email protected]
Betty Tong, MD, मुख्य अन्वेषक
भर्ती जारी

Ohio

Ohio State University, Columbus, Ohio, 43210, United States
Peter Kneuertz, MD, संपर्क, 614-293-9059, [email protected]
Peter Kneuertz, MD, मुख्य अन्वेषक
अभी भर्ती शुरू नहीं

Tennessee

University of Tennessee Health Science Center, Memphis, Tennessee, 38120, United States
Thomas Ng, MD, संपर्क, 901-226-0458, [email protected]
Thomas Ng, MD, मुख्य अन्वेषक
भर्ती जारी

Texas

MD Anderson Cancer Center, Houston, Texas, 77030, United States
Mara Antonoff, MD, संपर्क, 612-964-6469, [email protected]
Mara Antonoff, MD, मुख्य अन्वेषक
भर्ती जारी