Trial Title:
A Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention for Improving Physical Activity in Hispanic or Latino/Latina Adolescent and Young Adult Childhood Cancer Survivors, Walking Juntos Study
NCT ID:
NCT06410209
Condition:
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Prevention
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking description:
Investigators and participating site staff are blinded.
Intervention:
Intervention type:
Other
Intervention name:
Goal Setting
Description:
Set physical activity goals
Arm group label:
Stage 1 (Fitbit, interview)
Arm group label:
Stage 2, Group I (Fitbit, goal setting, peer support)
Intervention type:
Other
Intervention name:
Interview
Description:
Participate in a one-on-one interview
Arm group label:
Stage 1 (Fitbit, interview)
Arm group label:
Stage 2, Group I (Fitbit, goal setting, peer support)
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Stage 2, Group I (Fitbit, goal setting, peer support)
Arm group label:
Stage 2, Group II (Fitbit)
Intervention type:
Other
Intervention name:
Media Intervention
Description:
View private social media peer support group content
Arm group label:
Stage 1 (Fitbit, interview)
Arm group label:
Stage 2, Group I (Fitbit, goal setting, peer support)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear a Fitbit physical activity tracker
Arm group label:
Stage 1 (Fitbit, interview)
Arm group label:
Stage 2, Group I (Fitbit, goal setting, peer support)
Arm group label:
Stage 2, Group II (Fitbit)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear a research grade activity measuring device
Arm group label:
Stage 1 (Fitbit, interview)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Stage 1 (Fitbit, interview)
Arm group label:
Stage 2, Group I (Fitbit, goal setting, peer support)
Arm group label:
Stage 2, Group II (Fitbit)
Intervention type:
Other
Intervention name:
Reward
Description:
Receive badges
Arm group label:
Stage 2, Group I (Fitbit, goal setting, peer support)
Intervention type:
Other
Intervention name:
Text Message-Based Navigation Intervention
Description:
Receive text messages
Arm group label:
Stage 1 (Fitbit, interview)
Other name:
Automated Text Message-Based Navigation
Other name:
Text Message-Based Navigation
Intervention type:
Other
Intervention name:
Text Message-Based Navigation Intervention
Description:
Receive reminders
Arm group label:
Stage 2, Group I (Fitbit, goal setting, peer support)
Other name:
Automated Text Message-Based Navigation
Other name:
Text Message-Based Navigation
Summary:
This clinical trial tests the impact of a culturally-tailored home-based physical
activity program on physical fitness in Hispanic or Latino/Latina adolescent and young
adult (AYA) childhood cancer survivors. After treatment for cancer, some AYA survivors
experience long-term effects from the cancer and its treatment including weight gain,
fatigue and decreased physical fitness. Hispanic or Latino/Latina survivors may have a
higher risk of these effects compared to non-Hispanics. Regular physical activity helps
maintain healthy weight, energy levels and overall health. Participating in a
culturally-tailored home-based physical activity program may help increase physical
activity in Hispanic or Latino/Latina AYA childhood cancer survivors.
Detailed description:
PRIMARY OBJECTIVES:
I. Use an iterative approach to develop a culturally-tailored multilevel remote-based
physical activity (PA) intervention among a total of 20 Latinx adolescent and young adult
survivors of childhood cancer (AYA survivors), 8-12 whose preferred language is English
and 8-12 whose preferred language is Spanish, using the StepByStep intervention as a
starting point. (Stage 1) II. Conduct a randomized controlled trial (RCT) to test the
potential efficacy of the culturally-tailored remote-based PA intervention (versus [vs.]
Fitbit only) with respect to the primary outcome of moderate to vigorous physical
activity (MVPA) measured with a research grade accelerometer over 12 weeks among a
separate group of 170 Latinx AYA survivors whose preferred language is Spanish or English
(n=85 per randomization arm) and who do not meet PA guidelines at baseline. (Stage 2)
SECONDARY OBJECTIVES:
I. Among the patients enrolled to the RCT component of the study, evaluate the potential
efficacy of randomization to the intervention relative to control arm with respect to
decreasing sedentary time as assessed by a research accelerometer.
II. Evaluate potential efficacy of randomization to the active intervention arm with
respect to improvement in reported health-related quality of life.
EXPLORATORY OBJECTIVES:
I. Evaluate potential efficacy of randomization to the active intervention arm with
respect to physiological measurements predictive of cardiometabolic health.
II. Determine the acceptability of and guidance on improving the intervention phases in
preparation for a fully powered, long term RCT by conducting two rounds of post-trial
qualitative interviews among selected consenting participants, n=30 for the intensive
intervention phase and n=30 for the maintenance intervention phase.
OUTLINE:
STAGE 1: Patients wear a Fitbit physical activity tracker daily, set physical activity
goals, receive text messages, and view private social media peer support group content
over 7-10 days once every 3 months. Patients also wear a research grade activity
measuring device over 1-3 days and participate in a one-on-one interview once every 3
months for 9 months.
STAGE 2: Patients are randomized to 1 of 2 groups.
GROUP I (INTERVENTION):
INTENSIVE PHASE: Patients wear a Fitbit physical activity tracker daily and receive
weekly reminders to wear the Fitbit for 12 weeks. Patients attend weekly goal setting
sessions, receive individualized physical activity goals, view and post private social
media peer support group content 2-3 times weekly, and receive badges for 12 weeks.
MAINTENANCE PHASE: Patients wear a Fitbit physical activity tracker daily and set their
own physical activity goals weekly for 4 weeks. Patients also receive access to the
social media account and post content for 4 weeks.
GROUP II (CONTROL): Patients wear a Fitbit physical activity tracker daily for 12 weeks.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient must be ≥ 15 years and < 21 years at the time of enrollment
- 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: Children's Oncology
Group (COG) therapeutic trial participation is not required
- Completed all chemotherapy and/or radiation therapy in the last 3-36 months. This
includes completion of all oral (e.g., tyrosine kinase inhibitors) and/or
maintenance chemotherapy
- Self-report of < 420 minutes of moderate-to-vigorous physical activity per week as
assessed and documented via the study-specific Physical Activity Worksheet. Note:
See the case report forms packet on the COG study web page for the study specific
Physical Activity Worksheet
- Ambulatory and no known medical contraindications to increasing physical activity
- 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 Spanish or English
- Self-identify as Hispanic, Latino/Latina/Latinx
Exclusion Criteria:
- Patients with previous allogeneic 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
- 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
- Participants who were enrolled in ALTE2031 (Step by Step) cannot enroll in ALTE2321.
Participants who were enrolled in ALTE2321 Stage 1 (cultural tailoring) cannot
enroll to participate in Stage 2 (RCT)
- 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
Gender:
All
Minimum age:
15 Years
Maximum age:
20 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Saint Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-226-4343
Email:
referralinfo@stjude.org
Investigator:
Last name:
Kirsten K. Ness
Email:
Principal Investigator
Start date:
October 7, 2024
Completion date:
September 15, 2027
Lead sponsor:
Agency:
Children's Oncology Group
Agency class:
Other
Source:
Children's Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06410209
