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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Educational Intervention
  Attend telephone-based coaching sessions
• Другое Educational Intervention
  Receive written educational materials on physical activity and standard preoperative care
• Другое Exercise Intervention
  Receive a personalized physical activity program, set fitness goals
• Другое Medical Device Usage and Evaluation
  Wear activity monitor
• Другое Physical Performance Testing
  Ancillary studies
• Другое Quality-of-Life Assessment
  Ancillary studies
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Objective patient functional capacity [Срок оценки: At 30 days post discharge]

Вторичные конечные точки (9)

• Functional capacity [Срок оценки: At 60 and 180 days post discharge]
• Lower extremity function [Срок оценки: At 30, 60 and 180 days post discharge]
• Patient and caregiver reported self efficacy [Срок оценки: At 30, 60, and 180 days post discharge]
• Patient and caregiver reported physical function [Срок оценки: At 30, 60 and 180 days post discharge]
• Patient reported quality of life [Срок оценки: At 30, 60 and 180 days post discharge]
• Caregiver reported quality of life [Срок оценки: At 30, 60 and 180 days post discharge]
• Patient time at home and away from the hospital [Срок оценки: Up to 60 days post discharge]
• Hospital readmissions [Срок оценки: Up to 60 days post discharge]
• Postoperative complications [Срок оценки: Up to 60 days post discharge]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 16 центров

• University of California — Davis
• City of Hope Medical Center — Duarte
• City of Hope at Irvine Lennar — Irvine
• Standard University — Stanford
• City of Hope at Upland — Upland
• Yale New Haven Medical Center — New Haven
• Moffitt Cancer Center — Tampa
• City of Hope at Georgia - Atlanta — Newnan
• … и ещё 8 центров

Публикации

• Sun V, Guthrie KA, Arnold KB, Antonoff M, Erhunmwunsee L, Borondy-Kitts A, Johnson J, Jones L, Ramirez M, Tong BC, Moremen JR, Yang CJ, Ng T, Kim SS, Brown LM, Blasberg JD, Lui NS, Kneuertz PJ, Toloza EM, Kim JY, Raz DJ. Comparative effectiveness of perioperative physical activity in older adults with lung cancer and their family caregivers: design of a multicenter pragmatic randomized trial. BMC PMID 39118035

Идентификаторы

NCT: NCT06196008 · 23317 · NCI-2023-09810 · 23317 · P30CA033572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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