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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Is currently between the ages of 18-39 years

Their primary brain tumor was diagnosed at age 15-39 years

Is 6 months to <5 years post curative treatment

Has been treated with chemotherapy and radiation, given most patients receive both therapies.

Disqualifiers

Non-English speaking

Screen failure for exercise safety

Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease

Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions

Trial design

Design model

Single group

Treatments tested in this trial

  • Survivorship Education

    Behavioral

    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 Intervention

    Behavioral

    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.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Participant Group/ArmExperimental treatment 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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)
2

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)
3

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.

Time frame
Measured at T1 (baseline), T2 (12 weeks), and T3 (24 weeks)
4

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)

Other outcomes

Sponsors and contacts

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M.D. Anderson Cancer Center

Lead sponsor

Cancer Prevention Research Institute of Texas

Collaborator

UTHealth School of Medicine

Collaborator