Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study

Обзор

This research study will compare the impact of virtually supervised and unsupervised home-based exercise and diet programs on cognitive and physical function among cancer survivors and support persons. This study will involve a 6-month home-based virtually supervised or unsupervised exercise and diet intervention. The names of the study interventions involved in this study are: * Virtually supervised exercise and healthy diet care * Unsupervised exercise and healthy diet care

Подробное описание

This is a multi-center, parallel arm, comparative effectiveness trial to compare the impact of supervised and unsupervised home-based exercise and diet programs on cognitive function and physical function among cancer survivors and support persons.

Participants and support persons in this study will be randomly assigned to one of two groups: Group A: Virtually Supervised Care or Group B: Unsupervised Care. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, in-clinic visits, evaluations of fitness, physical health, diet, and cognitive function, surveys, and questionnaires.

Participation in this study is expected to last 12 months.

It is expected about 1528 people will participate in this research study.

Patient Centered Outcomes Research Institute (PCORI) is supporting this research study by providing funding for the study.

Вмешательства

• Поведенческое Supervised Exercise and Diet Program
  A home-based, virtually supervised, moderate-to-vigorous aerobic and resistance exercise intervention with a certified cancer exercise trainer. The exercise sessions will include aerobic exercise on a stationary bicycle and total-body resistance training using resistance bands. Stationary bicycle, resistance bands, activity tracking watch, and Wi-Fi enabled tablet (if needed) will be provided to participants. Dyads will receive remotely delivered nutrition coaching sessions (via telephone or vid
• Поведенческое Unsupervised Exercise and Diet Program
  A home-based, unsupervised moderate-to-vigorous aerobic and resistance exercise intervention. The exercise sessions will include aerobic exercise on a stationary bicycle and total-body resistance training using resistance bands. Stationary bicycle, resistance bands, activity tracking watch will be provided to participants. Dyads will receive Mediterranean eating pattern goals, with an introductory session conducted by research staff. Diet intake will be tracked using the journal feature My Welln

Первичные конечные точки

• Change in Global Cognition [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Change in Cognitive Function [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Change in Physical Function (6-minute walk test) [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Change Physical Function (Short Physical Performance Battery [SPPB]) [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Change in Physical Function (Timed-Up-And-Go (TUG) Test) [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Change in Physical Function (Gait Speed) [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Change in Physical Function (Sit-to-Stand Test) [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Change in Physical Function (Grip Strength) [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Change in Physical Function (Frailty) [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Change in Physical Function (Cardiorespiratory Fitness) [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]

Вторичные конечные точки (6)

• Accelerometer-Captured Physical Activity [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Patient-Reported Outcome: PROMIS-29 Quality of Life Questionnaire [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Patient-Report Outcome: PROMIS Cognitive Function Questionnaire [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Mediterranean Eating Pattern [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Alternate Mediterranean Diet Score (aMED) [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]
• Carotenoid Scan [Срок оценки: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)]

Критерии участия

Inclusion Criteria for Survivor Participants:

• Ability to understand and the willingness to sign informed consent prior to any study- related procedures.
• Older adults (≥65 years of age); cancer survivors who are at higher risk for developing comorbid conditions related to physical and cognitive function due to age declines.
• Completed chemotherapy and/or targeted therapy in the previous 36 months; said treatment exposure negatively impacts cognitive and physical function.
• Diagnosed with breast, lung, prostate, or colorectal cancer which are obesity-related cancers with higher risk for developing comorbid conditions related to physical and cognitive function.
• No detection of dementia as measured by scoring ≥ 23/41 on the Telephone Interview for Cognitive Status (TICS); it may be unsafe for individuals with dementia to participate in the intervention, and they may not be able to experience measurable cognitive improvement. Additionally, scores on cognitive measures could reflect task comprehension failure - not actual cognitive ability - as individuals with dementia may not be able to comprehend or follow the test instructions
• Overweight/obese: BMI ≥25 kg/m2 (calculated using height and weight) or body fat >35% for people assigned female at birth and >25% for people assigned male at birth (estimated by bioelectrical impedance); higher body weight negatively impacts cognitive and physical function.
• Currently participating in <60 minutes of structured moderate-to-vigorous exercise per week (determined by screening questionnaire); sedentary cancer survivors have a higher need and are more likely to benefit from exercise exposure.
• No history of disordered eating; to avoid triggering of past eating disorders with a diet intervention program.
• Reside with an (≥18 years of age) informal support person willing to participate; survivor/support person dyads will participate in the trial together per the goals of the trial and finding mechanism.
• Speak English or Spanish; the study teams will only be able to accommodate for these two languages at this time.
• Willing to travel to the respective site for necessary data collection.

Inclusion Criteria for Support Person:

• Adults ≥18 years of age; the intervention is not designed for adolescent and pediatric populations.
• No detection of dementia as measured by scoring ≥ 23/41 on the Telephone Interview for Cognitive Status (TICS); it may be unsafe for individuals with dementia to participate in the intervention, and they may not be able to experience measurable cognitive improvement. Additionally, scores on cognitive measures could reflect task comprehension failure - not actual cognitive ability - as individuals with dementia may not be able to comprehend or follow the test instructions
• No history of disordered eating; to avoid triggering of past eating disorders with a diet intervention program.
• Speak English or Spanish; the study teams will only be able to accommodate for these two languages at this time.

Exclusion Criteria for Survivor Participants:

• Adult cancer survivors less than 65 years of age.
• Survivors with a TICS score ≤ 22/41
• Survivors with a BMI <25 kg/m2 and body fat <35% for people assigned female at birth and <25% for people assigned male at birth.
• Survivors currently consuming a Mediterranean Diet or meeting 2 or more out of the following 3 Mediterranean eating pattern goals in the prior 6 weeks: ≥3 servings of vegetables per day, ≥ 3 servings of beans and legumes per week, or ≥ 1 serving of nuts per day.
• Survivors with unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Persons with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of participant safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, participants with unstable medical conditions will be excluded. This will be evaluated through the PAR- Q.
• Subjects with severe psychiatric conditions such as Active Major Depression, Bipolar Disorder, significant Suicidal ideation, and an active substance use and/or substance abuse disorder; these conditions can 1) adversely affect important cognitive test measures and 2) the ability to complete certain circumscribed interventions in the study.
• Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
• Survivors receiving treatment for an active malignancy (exceptions are treatment for basal cell carcinoma. They may receive long term treatments for their diagnosed breast, lung, prostate or colorectal cancer including hormone therapy). This study is exclusively targeting survivors post-primary cancer treatment.

Exclusion Criteria for Support Person:

• Support persons less than 18 years of age.
• Support persons with a TICS score ≤ 22/41
• Given the age range of support persons include those in childbearing years, people who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses.
• Support persons with unstable comorbidities that prevent participation in moderate-to- vigorous intensity exercise. Persons with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of participant safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, participants with unstable medical conditions are excluded.
• Support persons with severe psychiatric conditions such as Active Major Depression, Bipolar Disorder, significant Suicidal ideation, and an active substance use and/or substance abuse disorder; these conditions can 1) adversely affect important cognitive test measures and 2) the ability to complete certain circumscribed interventions in the study.
• Support persons receiving treatment for an active malignancy or are less than 10 years from the completion of any cancer treatment (exceptions are treatment for basal cell carcinoma). This is to preserve the "role" of the cancer survivor in the dyad.

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 · 2 центра

• University of Miami Sylvester Comprehensive Cancer Center — Miami
• Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT06623097 · 23-697

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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