Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial

Обзор

This study aims to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.

Подробное описание

The purpose of this study is to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.

Participants will be randomized into one of two groups: Group A: Interrupted Sedentary Time Intervention vs. Group B: Usual Care Control Group. Randomized means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, assessments of fitness and physical health, blood tests, and questionnaires.

Participation in this research study is expected to last about 3 months.

It is expected that about 24 people will take part in this research study.

Вмешательства

• Поведенческое Interrupted Sedentary Time Intervention
  A 12-week, semi-supervised exercise intervention comprised of reminder prompts, counseling, and activities of walking, cycling, and resistance band exercise for at-home and in-clinic settings. Supervision will be under an exercise trainer. Resistance bands, Libre Pro continuous blood sugar monitor, and Fitbit and ActivPAL trackers will be provided to participants.

Первичные конечные точки

• Intervention Completion Rate (Feasibility) [Срок оценки: 12 weeks]
• Refusal Rate [Срок оценки: 12 weeks]
• Retention Rate [Срок оценки: 13 weeks]
• Acceptability of Intervention Measure (AIM) Scale [Срок оценки: 13 weeks]
• Acceptability Exit Survey [Срок оценки: 13 weeks]

Вторичные конечные точки (2)

• Participant Glucose Level [Срок оценки: Assessed for one week at each timepoint (baseline & post-intervention).]
• Participant Insulin Resistance [Срок оценки: Assessed for one week at each timepoint (baseline & post-intervention).]

Критерии участия

Критерии включения

• Ability to understand and the willingness to sign informed consent prior to any study- related procedures.
• Patients diagnosed with lymphoma.
• Will receive first line R-CHOP or POLA-R-CHP chemotherapy regimens, patients do not need to be within a certain timeframe from diagnosis.
• Aged ≥18 years; due to the rarity of the disease in those <18 years, this age bracket will not be included.
• Engaging in ≤60-minutes of structured moderate or vigorous intensity exercise.
• Have physician clearance to participate in exercise.
• Speak English.
• Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions.
• Access to a phone that can receive text messages.

Критерии исключения

• Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded.
• Participate in more than 60 minutes of structured moderate-to-vigorous exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current interrupted sedentary time intervention.
• Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting lymphoma chemotherapy-related effects.
• Patients currently taking weight loss drugs.
• Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.
• Unable to travel to DFCI Longwood campus for necessary data collection and chemotherapy infusions.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Dana Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT06923397 · 24-765

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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