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POWER UP: Participating Online While Exercising to Recover Using Play

Primary Purpose

Exercise, Central Nervous System Tumors, Tumors

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focus Groups
Pilot randomized controlled trial
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

In order to be eligible to participate in Aim 1 of this study, an individual must meet all of the following criteria:

Round 1 focus groups:

  1. Oncologists who are caring for AYA cancer survivors or
  2. Survivorship care providers who actively engage with AYA cancer survivors

Round 2 focus groups:

  1. AYA cancer survivors age 15-39 years old
  2. Self-reported diagnosis of a primary benign or malignant CNS tumor or confirmed diagnosis of primary benign or malignant CNS tumor radiographically or pathologically when available
  3. ≤1-year post surgery and can have other tumor-directed treatment (e.g., radiation and/or chemotherapy)
  4. Participants and/or guardians are willing and able to provide informed consent
  5. Able to speak, read, and understand English
  6. Daily access to the web
  7. Can receive physical therapy because this is part of the standard of care

In order to be eligible to participate in Aim 2 of this study, an individual must meet all of the following criteria:

  1. Age 15-39 years old
  2. Self-reported diagnosis of a primary benign or malignant CNS tumor or confirmed diagnosis of primary benign or malignant CNS tumor radiographically or pathologically when available
  3. ≤1-year post surgery and can have other tumor-directed treatment (e.g., radiation and/or chemotherapy)
  4. Participant is insufficiently active (reports less than 150 minutes of planned moderate-vigorous intensity activity per week in the prior week)
  5. Able to speak, read, and understand English
  6. Daily access to the web
  7. Approval to participate from the oncology care team
  8. Participants and/or guardians are willing and able to provide informed consent
  9. Able to move arms and legs as well as ambulate safely with and without a gait aid
  10. Available space on the smartphone to download required apps
  11. Can receive physical therapy because this is part of the standard of care
  12. Participants and/or guardians are willing and able to provide informed consent for protocol PA18-0130 (Pediatric Energy Balance Data Repository Study), companion protocol for the Fitbit application/assessment.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in Aim 1 of this study:

Round 1 Focus Groups:

1. Do not have access to the internet

Round 2 Focus Groups:

  1. Another member of the household is a participant or staff member on this trial
  2. Do not have access to the internet
  3. In foster care or is incarcerated
  4. Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
  5. Self-reported diagnosis of a metastatic CNS tumor or confirmed diagnosis of a metastatic CNS tumor radiographically or pathologically when available

An individual who meets any of the following criteria will be excluded from participation in Aim 2 of this study:

  1. Currently pregnant
  2. Currently have dementia
  3. Plans to travel for more than 2 weeks at a time during the study period where the participant is not able to sign in to join the videoconferencing sessions
  4. Clinical judgment by the oncology care team concerning safety based on the Physical Activity Readiness Questionnaire for Everyone (2020 PAR-Q+)
  5. Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
  6. Self-reported diagnosis of a metastatic CNS tumor or confirmed diagnosis of a metastatic CNS tumor radiographically or pathologically when available
  7. Currently participating in an organized commercial or research-based exercise program
  8. Another member of the household is a participant or staff member on this trial

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Aim 1. Focus Groups

Aim 2. Pilot randomized controlled trial:

Arm Description

Healthcare providers (n=16-24 participants in 4 focus groups) from MD Anderson Cancer Center (MDACC). AYAs with primary benign or malignant central nervous system tumors (n=16-24 participants in 4 focus groups) treated at MDACC.

AYAs with primary benign or malignant central nervous system tumors (n=80 patients approached, with n= 40 participants consented and randomized to the intervention (n=20) or usual care control group (n=20)) treated at MDACC, any gender and race, who are ≤1-year post-surgery for a central nervous system tumor.

Outcomes

Primary Outcome Measures

Quality of Life Questionnaire
PROMIS 29 includes the following domains Physical Function (5=without any difficulty, 1=unable to do) Anxiety (5=always, 1=never) Depression (5=always, 1=never) Fatigue (5=very much, 1=not at all) Sleep Disturbance (5=very poor, 1=very good) Ability to participate in Social Roles and Activities(5=never, 1=always) Pain Interference (5=very much, 1=not at all) Pain Intensity (10=worst pain imaginable, 0=no pain)

Secondary Outcome Measures

Full Information

First Posted
March 15, 2022
Last Updated
May 25, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05308407
Brief Title
POWER UP: Participating Online While Exercising to Recover Using Play
Official Title
POWER UP: Participating Online While Exercising to Recover Using Play
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
We will conduct a two-phase study. The first phase is to adapt and develop an active video game (AVG)-centered lifestyle physical activity (PA) intervention (POWER UP) for adolescents and young adults (AYA) with central nervous system tumors. The second phase is to test the feasibility and preliminary efficacy of a 12-week virtually delivered, group-based active video game-centered lifestyle physical activity intervention on function and quality of life in AYAs (aged 15-39) who are ≤1-year post-surgery for a central nervous system tumor. This population is at very high-risk for steep functional decline.
Detailed Description
Objective: To develop (Aim 1) and test (Aim2, Primary Objective) the feasibility and acceptability of a virtually delivered, group-based active video game-centered lifestyle physical activity intervention targeting affect to improve function and quality of life in insufficiently active AYAs with central nervous system tumors. Also, (Aim 2, Secondary Objective) in a pilot randomized trial, compare the physical function, quality of live, and physical activity level between intervention and control groups. Primary: Feasibility and acceptability of the POWER UP intervention and assessments. Secondary: Physical function, quality of life (QOL), symptoms, and PA levels as measured at the 12- and 24-week follow ups . Other endpoints relevant to the primary and secondary objectives: BMI status, dietary intake, Fitbit data (days worn and steps), exercise motivation, basic psychological needs at the 12- and 24-week follow-ups

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Central Nervous System Tumors, Tumors

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aim 1. Focus Groups
Arm Type
Other
Arm Description
Healthcare providers (n=16-24 participants in 4 focus groups) from MD Anderson Cancer Center (MDACC). AYAs with primary benign or malignant central nervous system tumors (n=16-24 participants in 4 focus groups) treated at MDACC.
Arm Title
Aim 2. Pilot randomized controlled trial:
Arm Type
Other
Arm Description
AYAs with primary benign or malignant central nervous system tumors (n=80 patients approached, with n= 40 participants consented and randomized to the intervention (n=20) or usual care control group (n=20)) treated at MDACC, any gender and race, who are ≤1-year post-surgery for a central nervous system tumor.
Intervention Type
Other
Intervention Name(s)
Focus Groups
Intervention Description
No intervention involved in this phase of the study
Intervention Type
Other
Intervention Name(s)
Pilot randomized controlled trial
Intervention Description
The intervention is a virtually delivered, 12 weekly group-based active video game-centered lifestyle physical activity intervention (POWER UP) targeting affect to improve function and quality of life in insufficiently active AYAs with central nervous system tumors.
Primary Outcome Measure Information:
Title
Quality of Life Questionnaire
Description
PROMIS 29 includes the following domains Physical Function (5=without any difficulty, 1=unable to do) Anxiety (5=always, 1=never) Depression (5=always, 1=never) Fatigue (5=very much, 1=not at all) Sleep Disturbance (5=very poor, 1=very good) Ability to participate in Social Roles and Activities(5=never, 1=always) Pain Interference (5=very much, 1=not at all) Pain Intensity (10=worst pain imaginable, 0=no pain)
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in Aim 1 of this study, an individual must meet all of the following criteria: Round 1 focus groups: Oncologists who are caring for AYA cancer survivors or Survivorship care providers who actively engage with AYA cancer survivors Round 2 focus groups: AYA cancer survivors age 15-39 years old Self-reported diagnosis of a primary benign or malignant CNS tumor or confirmed diagnosis of primary benign or malignant CNS tumor radiographically or pathologically when available ≤1-year post surgery and can have other tumor-directed treatment (e.g., radiation and/or chemotherapy) Participants and/or guardians are willing and able to provide informed consent Able to speak, read, and understand English Daily access to the web Can receive physical therapy because this is part of the standard of care In order to be eligible to participate in Aim 2 of this study, an individual must meet all of the following criteria: Age 15-39 years old Self-reported diagnosis of a primary benign or malignant CNS tumor or confirmed diagnosis of primary benign or malignant CNS tumor radiographically or pathologically when available ≤1-year post surgery and can have other tumor-directed treatment (e.g., radiation and/or chemotherapy) Participant is insufficiently active (reports less than 150 minutes of planned moderate-vigorous intensity activity per week in the prior week) Able to speak, read, and understand English Daily access to the web Approval to participate from the oncology care team Participants and/or guardians are willing and able to provide informed consent Able to move arms and legs as well as ambulate safely with and without a gait aid Available space on the smartphone to download required apps Can receive physical therapy because this is part of the standard of care Participants and/or guardians are willing and able to provide informed consent for protocol PA18-0130 (Pediatric Energy Balance Data Repository Study), companion protocol for the Fitbit application/assessment. Exclusion Criteria An individual who meets any of the following criteria will be excluded from participation in Aim 1 of this study: Round 1 Focus Groups: 1. Do not have access to the internet Round 2 Focus Groups: Another member of the household is a participant or staff member on this trial Do not have access to the internet In foster care or is incarcerated Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team. Self-reported diagnosis of a metastatic CNS tumor or confirmed diagnosis of a metastatic CNS tumor radiographically or pathologically when available An individual who meets any of the following criteria will be excluded from participation in Aim 2 of this study: Currently pregnant Currently have dementia Plans to travel for more than 2 weeks at a time during the study period where the participant is not able to sign in to join the videoconferencing sessions Clinical judgment by the oncology care team concerning safety based on the Physical Activity Readiness Questionnaire for Everyone (2020 PAR-Q+) Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team. Self-reported diagnosis of a metastatic CNS tumor or confirmed diagnosis of a metastatic CNS tumor radiographically or pathologically when available Currently participating in an organized commercial or research-based exercise program Another member of the household is a participant or staff member on this trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Swartz, MD
Phone
713-745-3763
Email
mchang1@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Swartz, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Swartz, MD
Phone
713-745-3763
Email
mchang1@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Maria Swartz, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

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POWER UP: Participating Online While Exercising to Recover Using Play

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