Cancer-related Fatigue and Its Biological Contributors in Adolescent and Young Adult Brain Tumor Survivors: Effects of a Tele-exercise Intervention

M.D. Anderson Cancer Center75 enrolled

Overview

The goal of this research study is to learn about the effects of the RISE-YA intervention on cancer-related fatigue in young adults who are brain cancer survivors.

Primary Objective: Test the efficacy of RISE-YA to improve CRF Secondary Objectives: 1. Test the efficacy of RISE-YA to improve PA and physical function in fatigued YA brain tumor survivors. 2. Determine A) cross-sectional associations of CRF with oxidative phosphorylation (OxPhos) and with inflammation, and B) the effect of RISE-YA on OxPhos and on inflammation. Exploratory Objective: Assess the effect of our supervised exercise intervention on patient-reported health-related quality of life, muscle mass development (BMI, skinfold and circumferences \[waist, arm, and calf area\]), patient-reported dietary intake, and exercise adherence and progression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cancer Fatigue Brain Tumor Adult

Interventions

Survivorship EducationBEHAVIORAL

Participants will participate in discussions with a trainer via videoconference of any adverse events, resolving technical issues related to the activity tracker, and discussing survivorship topics using the NCI's Facing Forward Life After Cancer Treatment booklet. Participants will receive calls twice weekly during weeks 1-6 and once weekly during weeks 7-12

RISE-YA InterventionBEHAVIORAL

Participants will receive one-on-one energy conservation (EC) counseling, behavior coaching, and individualized, progressive strength and aerobic training exercises with a trainer via videoconference. Participants will receive calls twice weekly during weeks 1-6 and once weekly during weeks 7-12. Each call will last one hour. Participants will also receive prescriptions for self-led exercise sessions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Is currently between the ages of 18-39 years 2. Their primary brain tumor was diagnosed at age 15-39 years 3. Is 6 months to \<5 years post curative treatment 4. Has been treated with chemotherapy and radiation, given most patients receive both therapies. 5. Functional Assessment of Chronic Illness therapy (FACIT)-Fatigue ≤ 43. FACIT-Fatigue will be used as a screener because this 13-item scale can be completed relatively quickly in clinic 6. Currently engage in \<150 minutes of PA and \< 2 sessions of muscle strengthening exercise per week (assessed by Godin Leisure-Time PA Questionnaire) 7. Must be able to speak, write, and read English 8. No exercise contraindication as assessed by screening with the Physical Activity Readiness Questionnaire PAR-Q+. In addition, participants' care teams will be notified of their participation in the study. 9. Must be able to provide informed consent/assent. Exclusion Criteria: 1. Non-English speaking 2. Screen failure for exercise safety 3. Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease 4. Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions 5. History of underlying chronic disease, secondary malignances, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain 6. Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team. 7. Self-report of pregnancy 8. Prisoners 9. Documented developmental disorders (e.g., Autism) or major psychotic illness (e.g., schizophrenia)

Locations (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Cancer Related Fatigue

To compare changes in cancer related fatigue at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: Multi-dimensional Fatigue Inventory. Scores range from 20 to 100, with higher values indicating greater fatigue severity

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Secondary Outcomes

Physical Activity (PS)

To compare changes in PA at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: PA will be measured via a wearable activity tracker (ActiGraph GT3XP), worn on the waist for 7 consecutive days during all waking hours. The daily average of activity volume (incorporating movement along 3 axes vs. 2 axes for steps) will be computed as indicator of lifestyle PA. Greater number (minutes) indicates greater PA.

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Physical Function: Timed up and Go

To compare changes in physical function, as indicated by Timed up and Go test, at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: Time (in seconds) of how long it takes participant to stand up from a chair, walk 3 meters, turn around, return walk, and sit back down. Less time indicates greater function.

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Physical Function: Single Leg Stand

To compare changes in physical function, as indicated by Single leg stand, at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: Time (in seconds) of how long participant can stand with only one foot on the ground. Participants perform the test with eyes open and arms on the hips. Participants must stand unassisted on one leg. The test duration is measured from the moment the foot leaves the ground until participants: (1) touch the raised leg to the ground, (2) touch their legs together, (3) perform excessive trunk or upper body movements, or (4) an arm leaves the hips, (5)or until maximum time of 45 seconds is reached. The test includes two trials per leg, with the best score recorded. Longer time indicates greater function.

Central Contacts

Michael Roth, MD

CONTACT

(713) 792-7751 mroth1@mdanderson.org

Data from ClinicalTrials.gov

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Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Physical Function: 1-minute chair stand

To compare changes in Physical Function, as indicated by 1-minute chair stand, at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: The number of completed sit-to-stand repetitions participant completes in 1 minute. Participant must stand up from a chair using legs only. Larger number indicates greater function.

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Physical Function: 6-minute walk test

To compare changes in physical function, as indicated by the 6-minute walk test, at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: The distance traveled, in meters, the participant can walk in the course of 6 minutes. Larger number indicates greater function.

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Physical Function: handgrip strength

To compare changes in physical function, as indicated by handgrip strength, at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: The maximal isometric strength of the participant's handgrip, in kilograms, as measured by a dynamometer. The test includes three trials on each side, with the best score recorded. Greater number indicates greater function.

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Systemic immune inflammation index

To compare changes in systemic immune inflammation index at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: Systemic immune inflammation index will be calculated by the equation SII=P x N/L, where P is blood platelets, N is neutrophils, and L is lymphocytes (counts/L). Blood cell counts will be completed by an automated hematology analyzer. Lower score indicates lower inflammation.

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

High-sensitivity C-reactive protein (hs-CRP)

To compare changes in hs-CRP at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: hs-CRP concentration will be assayed in participant serum using a commercially available detection kit. Higher concentration indicates greater value of CRP (inflammation).

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Interleukin-6 (IL-6)

To compare changes in IL-6 at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: IL-6 concentration will be assayed in participant serum using a commercially available detection kit. Higher concentration indicates greater value of IL-6 (inflammation).

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Soluble tumor necrosis factor receptor-2 (sTNFR2)

To compare changes in sTNFR2 at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: sTNFR2 concentration will be assayed in participant serum using a commercially available detection kit. Higher concentration indicates greater value of sTNFR2

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Tumor necrosis factor (TNF)

To compare changes in TNF at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: TNF concentration will be assayed in participant serum using a commercially available detection kit. Higher concentration indicates greater value of TNF

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Interleukin-1 receptor alpha (IL-1ra)

To compare changes in IL-1ra at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: IL-1ra concentration will be assayed in participant serum using a commercially available detection kit. Higher concentration indicates greater value of IL-1ra

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Interleukin-10 (IL-10)

To compare changes in IL-10 at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: IL-10 concentration will be assayed in participant serum using a commercially available detection kit. Higher concentration indicates greater value of IL-10 (anti-inflammatory)

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)

Oxidative phosphorylation (OxPhos)

To compare changes in OxPhos at T2 and T3 relative to T1 between participants in the RISE-YA intervention and participants in the attention control. Measure: We will use Seahorse Analyzer technology and a mitochondrial stress kit to measure mitochondrial oxygen consumption rate under different conditions by treating blood cells ex vivo from participants with mitochondrial modulatory agents. Higher values indicate greater OxPhos

Time frame: Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)