ACTIVE_NOT_RECRUITING

Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for AYAO (OPT2MOVE)

Conditions

Cancer YACS eHealth physical activity mindfulness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the present study is to utilize Multiphase Optimization Strategy (MOST)1 to test four social support and mindfulness components (e-coaching, buddy, general mindfulness training, and MVPA-specific mindfulness training) in a 12-week mHealth moderate to vigorous intensity physical activity (MVPA) intervention in a sample of young adult cancer survivors (YACS), to improve quality of life (QOL) and decrease adverse effects and symptom burden. PRIMARY AIM To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 12 and 24 weeks SECONDARY AIM To examine how changes in MVPA, as a result of Opt2Move components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent in other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality THIRD AIM To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal setting) and moderators (cancer type, age, gender) of the four intervention components on MVPA.

Official Title

Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for Adolescent and Young Adult Cancer Survivors

Quick Facts

Study Start:2023-07-18

Study Completion:2026-02-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05375162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 39 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of nonmetastatic cancer (except non-melanoma skin cancer) within 5 years from the time of screening / study overview session * Age Diagnosis of cancer between 18-39 years at time of diagnosis and at time of screening / study overview session * Three or more months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies * Score of 0 on two of the Exercise Preparticipation Health Screening Questionnaire items or willingness to obtain medical clearance from a primary care physician or oncologist * Self-report engagement in \<60 minutes total each week of MVPA at time of screening / study overview session * Ownership of a smartphone that is either an iPhone (version 5 or greater) or an Android (version 5.0 or greater) * Internet access * Fluency in spoken and written English * Willingness, at time of screening / study overview session, to find a Buddy (someone who knows about their cancer and participation in this study and who is willing to participate by supporting them during the 6-month study), if assigned to that condition * Friend, co-worker, caregiver or family member of a participating YACS * Age 18 years or older * Score of 0 on the Exercise Preparticipation Health Screening Questionnaire or willingness to obtain medical clearance from a primary care physician * Ownership of a smartphone that is either an iPhone (version 5 or greater) or an Android (version 5.0 or greater) * Internet access * Fluency in spoken and written English * Willingness to share their Fitbit data with the study team	* For YACS: Diagnosis of non-melanoma skin cancer * Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery * Currently pregnant or plans to become pregnant in the next 12 months * Plans to move out of the United States in next 18 months * For YACS: Current enrollment in another dietary or physical activity trial * Inability to provide informed consent * Prisoners or other detained individuals

Inclusion Criteria

Exclusion Criteria

* Diagnosis of nonmetastatic cancer (except non-melanoma skin cancer) within 5 years from the time of screening / study overview session
* Age Diagnosis of cancer between 18-39 years at time of diagnosis and at time of screening / study overview session
* Three or more months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies
* Score of 0 on two of the Exercise Preparticipation Health Screening Questionnaire items or willingness to obtain medical clearance from a primary care physician or oncologist
* Self-report engagement in \<60 minutes total each week of MVPA at time of screening / study overview session
* Ownership of a smartphone that is either an iPhone (version 5 or greater) or an Android (version 5.0 or greater)
* Internet access
* Fluency in spoken and written English
* Willingness, at time of screening / study overview session, to find a Buddy (someone who knows about their cancer and participation in this study and who is willing to participate by supporting them during the 6-month study), if assigned to that condition
* Friend, co-worker, caregiver or family member of a participating YACS
* Age 18 years or older
* Score of 0 on the Exercise Preparticipation Health Screening Questionnaire or willingness to obtain medical clearance from a primary care physician
* Ownership of a smartphone that is either an iPhone (version 5 or greater) or an Android (version 5.0 or greater)
* Internet access
* Fluency in spoken and written English
* Willingness to share their Fitbit data with the study team

* For YACS: Diagnosis of non-melanoma skin cancer
* Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery
* Currently pregnant or plans to become pregnant in the next 12 months
* Plans to move out of the United States in next 18 months
* For YACS: Current enrollment in another dietary or physical activity trial
* Inability to provide informed consent
* Prisoners or other detained individuals

Contacts and Locations

Principal Investigator

Siobhan M Phillips, PhD, MPH

PRINCIPAL_INVESTIGATOR

Northwestern University

David E Victorson, PhD

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60611

United States

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27101

United States

Collaborators and Investigators

Sponsor: Northwestern University

Siobhan M Phillips, PhD, MPH, PRINCIPAL_INVESTIGATOR, Northwestern University
David E Victorson, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-18

Study Completion Date2026-02-22

Study Record Updates

Study Start Date2023-07-18

Study Completion Date2026-02-22

Terms related to this study

Keywords Provided by Researchers

YACS
cancer
eHealth
physical activity
mindfulness

Additional Relevant MeSH Terms

Cancer