Exercise and Nutrition for Older Cancer Survivors and The... | NCT06623097

Status Module

Name	Class
Patient-Centered Outcomes Research Institute	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: Virtually Supervised Care Comparator	Experimental	Complete virtually supervised exercise sessions 3x weekly with their study partner. Complete Mediterranean eating program coaching session 1x weekly.	Behavioral: Supervised Exercise and Diet Program
Arm 2: Unsupervised Care	Experimental	Receives exercise and diet intervention recommendations including 3x weekly workouts and healthy eating goals Weekly recorded informative videos 4x weekly supportive text messages Study website access and interventional booklet	Behavioral: Unsupervised Exercise and Diet Program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supervised Exercise and Diet Program	Behavioral	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 video conferencing) with a health coach each week. Mediterranean eating pattern goals will be tracked using the journal feature of the My Wellness Research platform website.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Global Cognition	The Montreal Cognitive Assessment (MOCA) will also be used to assess global cognition.	From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Cognitive Function	Cognitive function will be measured using the National Institutes of Health (NIH) toolbox (www.nihtoolbox.org). Within the NIH toolbox, executive function, immediate recall, memory, attention, working memory, and processing speed will be measured.	From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Physical Function (6-minute walk test)	The 6-minute walk test is also conducted to assess aerobic endurance and capacity. Distance achieved during the 6-minute walk test is recorded in meters.	From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change Physical Function (Short Physical Performance Battery [SPPB])	The SPPB is comprised of three sections: 1) balance with feet together, semi tandem, and full tandem is held for up to 10 seconds with no support (seconds); 2) usual gait speed over four meters is timed (seconds); and 3) chair stand where the time(s) to complete five chair sit-to-stands is recorded.	From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)
Change in Physical Function (Timed-Up-And-Go (TUG) Test)	The TUG test times how fast it takes a participant to stand up from a chair, walk around a cone placed three meters away from a chair where they start, and end in a seated position (seconds).	From baseline (month 0) to month 6 (post-intervention) to month 12 (follow-up)

Secondary Outcomes

Measure	Description	Time Frame
Accelerometer-Captured Physical Activity	Physical activity will be recorded for a week with ActiGraph accelerometer sensor. Physical activity also will be measured by self-report using the modified Godin Leisure-Time Exercise Questionnaire (GLTEQ), a 3-item measure with a score range of less than 14 units to 24 units or more. The higher the weekly total score represents the greater a participant's physical activity. The GLTEQ assesses current participation in any structured exercise and asks the participant how much time they spend exercising in a typical 7-day period.

Eligibility Module

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 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.

Name	Role	Phone	Extension	Email
Christina Dieli-Conwright, PhD, MPH	Contact	617-632-3800		christinam_dieli-conwright@dfci.harvard.edu
Jordan Lane, MSc	Contact	617-582-7494		jordan_lane@dfci.harvard.edu