Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels affect health and quality of life over time.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on physical activity among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines. SECONDARY OBJECTIVES: I. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on biomarkers predictive of cardiometabolic health among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines. II. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on health-related quality of life among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines. OUTLINE: Participants are randomized to 1 of 2 groups. INTERVENTION GROUP: Participants receive educational materials about physical activity. INTENSIVE PHASE (24 WEEKS): Participants wear a physical activity tracker (Fitbit) daily as well as receiving weekly reminders from study staff to wear it. They also receive goal setting sessions each week (by text, phone call, etc.) to set personalized step count goals using the Fitbit application (app). Lastly, participants receive an invitation to follow and post on an online social media peer support group (Instagram), where study staff provide encouraging advice and messages about physical activity 2-3 times per week, announce badges/awards every week, and moderate a forum to discuss physical activity and use of the Fitbit. MAINTENANCE PHASE (24 WEEKS): Participants wear a Fitbit daily but do not receive reminders to wear it. They also set their own step count goals weekly and check in with study staff monthly for assistance with goal setting. Participants take the lead posting content on the Instagram account moderated by the study staff. Study staff only post once per week with general physical activity-related questions and provide no badges. CONTROL GROUP: Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.
Interventions
OTHEREducational Intervention
Receive educational materials
DEVICEFitBit
Wear a Fitbit
OTHERGoal Setting
Set goals
OTHERHealth Promotion and Education
Receive text message about goal setting
OTHERMedia Intervention
Follow Instagram group
BEHAVIORALTelephone-Based Intervention
Receive phone call about goal setting
Sponsors
Children's Oncology Group
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* First diagnosis of malignant neoplasm (International Classification of Diseases for Oncology \[ICD-O\] behavior code of "3") in first and continuous remission at the time of enrollment * Curative cancer treatment must have included chemotherapy (including cellular therapy) and/or radiation (including radioactive iodine) * Note: Childrens Oncology Group (COG) therapeutic trial participation is not required * All cancer treatment must have been completed within 3-36 calendar months prior to enrollment * Patients must have a life expectancy of \> 1 year * Self-report of \< 420 minutes of moderate-to-vigorous physical activity per week as assessed via the study-specific Physical Activity Worksheet * Note: See COG Study Web Page for the Godin-Shephard Leisure Time Physical Activity Questionnaire or link to online calculator * Ambulatory and no known medical contraindications to increasing physical activity * Note: Patients with amputation, rotationplasty, or other prothesis are not automatically excluded as long as they are ambulatory and have no known medical contraindications to increasing physical activity and all other eligibility criteria are satisfied * No known significant physical or cognitive impairment that would prevent use of the electronic devices used for the protocol intervention (e.g. Fitbit, smartphone, tablet, or computer) * Able to read and write English * Note: For patients \< 18 years, consenting parent/legal guardian does not have to be able to read and write English * All patients and/or their parents or legal guardians must sign a written informed consent * Note: Informed consent may be obtained electronically/online if allowed by local site policy and Institutional Review Board (IRB)/Research Ethics Board (REB) of record * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion criteria
* Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded * Note: Pregnancy status can be established by clinical history with patient. Post-menarchal female patients are eligible as long as they agree to use an effective contraceptive method (including abstinence) during study participation * Patients with previous hematopoietic stem cell transplant (HSCT) are excluded * Note: Patients with previous autologous HSCT, chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate as long as all other eligibility criteria are satisfied
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minutes of moderate-to-vigorous physical activity (MVPA) per day | 12 months | Moderate-to-vigorous physical activity (MVPA) will be measured with a research-grade accelerometer which records minutes of MVPA over a 7 day period. This is used to calculate MVPA minutes at baseline and 12 months post-baseline. Total minutes above the moderate-intensity threshold will be divided by the number of valid days to obtain minutes of MVPA per day. Will report the mean difference in average daily minutes of MVPA from baseline to 12 months, by arm, with corresponding 95% confidence intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary fitness | 12 months | Cardiopulmonary fitness is an objective biomarker of exercise capacity and will be assessed by the 2-Minute Step Test. Participants complete the 2-Minute Step Test at baseline and 12 months post-baseline. Steps are counted during the test. Will report the mean difference in steps from baseline to 12 months, by arm, with corresponding 95% confidence intervals. |
| Resting heart rate | 12 months | Resting heart rate will be taken using the Fitbit physical activity tracker heart rate monitor prior to the participant initiating the 2-Minute Step Test at baseline and 12 months. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
| Health-related quality of life (HRQOL) Global Functioning | 12 months | HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Global Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
| Health-related quality of life (HRQOL) Physical Functioning | 12 months | HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Physical Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
| Health-related quality of life (HRQOL) Social Functioning | 12 months | HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Social Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
| Health-related quality of life (HRQOL) Fatigue | 12 months | HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Fatigue score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
| Total cholesterol | 12 months | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. Total cholesterol will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
| High density lipoprotein (HDL) | 12 months | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HDL will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
| Low density lipoprotein (LDL) | 12 months | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. LDL will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
| Triglycerides | 12 months | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. Triglycerides will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
| Insulin (HOMA-IR) | 12 months | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HOMA-IR will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
| Hemoglobin A1c (HbA1c) | 12 months | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HbA1c will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
| High sensitivity C-reactive protein (CRP) | 12 months | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. CRP will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORNina S Kadan-Lottick
Children's Oncology Group
Outcome results
None listed