Clinical trial NCT06623097: Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
Official title: Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Survivorship
Keywords: Cancer Survivorship
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-10-02
Enrollment: 1528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study will compare the impact of virtually supervised and unsupervised home-based exercise and diet programs on cognitive function 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

Detailed description: 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.

Eligibility criteria: 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 12 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 limiting cognitive impairment as measured by scoring ≥20 on the MoCA; moderate or severe cognitive impairment could impact ability to complete testing and intervention safely.
* Overweight/obese: BMI ≥25 kg/m2 (calculated using height and weight) or body fat \&gt;35% for people assigned female at birth and \&gt;25% for people assigned male at birth (estimated by bioelectrical impedance); higher body weight negatively impacts cognitive and physical function.
* Currently participating in \&lt;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 limiting cognitive impairment as measured by scoring ≥20 on the MoCA; moderate or severe cognitive impairment could impact ability to complete testing and intervention safely.
* 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 MoCA score \&lt;20.
* Survivors with a BMI \&amp;lt; 25 kg/m2 and body fat \&lt;35% for people assigned female at birth and \&lt;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. As a result, we will employ the Mini-International Neuropsychiatric Interview (M.I.N.I.) for the diagnosis of such conditions. For those who exhibit these conditions on the MINI, this will be considered as an exclusionary criterion, and the person will be immediately referred to the local Risk Management office.
* 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 MoCA score \&lt;20.
* 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. As a result, we will employ the Mini-International Neuropsychiatric Interview (M.I.N.I.) for the diagnosis of such conditions. For those who exhibit these conditions on the MINI, this will be considered as an exclusionary criterion, and the person will be immediately referred to the local Risk Management office.
* Support persons receiving treatment for an active malignancy or are \&lt;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.

Primary outcomes:
measure: Change in Global Cognition
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Change in Cognitive Function
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Change in Physical Function (6-minute walk test)
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Change Physical Function (Short Physical Performance Battery [SPPB])
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Change in Physical Function (Timed-Up-And-Go (TUG) Test)
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Change in Physical Function (Gait Speed)
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Change in Physical Function (Sit-to-Stand Test)
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Change in Physical Function (Grip Strength)
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Change in Physical Function (Frailty)
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Change in Physical Function (Cardiorespiratory Fitness)
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Change in Physical Function (Muscular Strength)
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Secondary outcomes:
measure: Accelerometer-Captured Physical Activity
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Patient-Reported Outcome: PROMIS-29 Quality of Life Questionnaire
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Patient-Report Outcome: PROMIS Cognitive Function Questionnaire
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Mediterranean Eating Pattern
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Alternate Mediterranean Diet Score (aMED)
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
measure: Carotenoid Scan
timeFrame: From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina Dieli-Conwright, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: