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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
interventionNames
Behavioral: Core Intervention
Behavioral: E-Coach
Behavioral: General Mindfulness Training
Behavioral: MVPA-Specific Mindfulness Training
Behavioral: Buddy
type
ACTIVE_COMPARATOR
label
Exp Condition 2
description
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training
interventionNames
Behavioral: Core Intervention
Behavioral: E-Coach
Behavioral: General Mindfulness Training
Behavioral: MVPA-Specific Mindfulness Training
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Maximum age
39 Years
Show eligibility criteria text
Inclusion Criteria:
For YACS
* 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
For "Buddies"
* 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
Exclusion Criteria:
* 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
References
Publications (51)
BACKGROUNDRabin C, Pinto B, Fava J. Randomized Trial of a Physical Activity and Meditation Intervention for Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2016 Mar;5(1):41-7. doi: 10.1089/jayao.2015.0033. Epub 2015 Oct 15. PMID 26812450
BACKGROUNDLiu L, Moke DJ, Tsai KY, Hwang A, Freyer DR, Hamilton AS, Zhang J, Cockburn M, Deapen D. A Reappraisal of Sex-Specific Cancer Survival Trends Among Adolescents and Young Adults in the United States. J Natl Cancer Inst. 2019 May 1;111(5):509-518. doi: 10.1093/jnci/djy140. PMID 30321398
BACKGROUNDMiller KD, Siegel RL, Lin CC, Mariotto AB, Kramer JL, Rowland JH, Stein KD, Alteri R, Jemal A. Cancer treatment and survivorship statistics, 2016. CA Cancer J Clin. 2016 Jul;66(4):271-89. doi: 10.3322/caac.21349. Epub 2016 Jun 2. PMID 27253694
BACKGROUNDBurkart M, Sanford S, Dinner S, Sharp L, Kinahan K. Future health of AYA survivors. Pediatr Blood Cancer. 2019 Feb;66(2):e27516. doi: 10.1002/pbc.27516. Epub 2018 Oct 26. PMID 30362237
BACKGROUNDSalsman JM, Garcia SF, Yanez B, Sanford SD, Snyder MA, Victorson D. Physical, emotional, and social health differences between posttreatment young adults with cancer and matched healthy controls. Cancer. 2014 Aug 1;120(15):2247-54. doi: 10.1002/cncr.28739. Epub 2014 May 28. PMID 24888335
BACKGROUNDNass SJ, Beaupin LK, Demark-Wahnefried W, Fasciano K, Ganz PA, Hayes-Lattin B, Hudson MM, Nevidjon B, Oeffinger KC, Rechis R, Richardson LC, Seibel NL, Smith AW. Identifying and addressing the needs of adolescents and young adults with cancer: summary of an Institute of Medicine workshop. Oncologist. 2015 Feb;20(2):186-95. doi: 10.1634/theoncologist.2014-0265. Epub 2015 Jan 7. PMID 25568146
BACKGROUNDFong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
type
ACTIVE_COMPARATOR
label
Exp Condition 3
description
Research participant receives the Core Intervention + E-Coach + Buddy
interventionNames
Behavioral: Core Intervention
Behavioral: E-Coach
Behavioral: Buddy
type
ACTIVE_COMPARATOR
label
Exp Condition 4
description
Research participant receives the Core Intervention + E-Coach
interventionNames
Behavioral: Core Intervention
Behavioral: E-Coach
type
ACTIVE_COMPARATOR
label
Exp Condition 5
description
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy
interventionNames
Behavioral: Core Intervention
Behavioral: E-Coach
Behavioral: General Mindfulness Training
Behavioral: Buddy
type
ACTIVE_COMPARATOR
label
Exp Condition 6
description
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training
interventionNames
Behavioral: Core Intervention
Behavioral: E-Coach
Behavioral: General Mindfulness Training
type
ACTIVE_COMPARATOR
label
Exp Condition 7
description
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy
interventionNames
Behavioral: Core Intervention
Behavioral: E-Coach
Behavioral: MVPA-Specific Mindfulness Training
Behavioral: Buddy
type
ACTIVE_COMPARATOR
label
Exp Condition 8
description
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training
interventionNames
Behavioral: Core Intervention
Behavioral: E-Coach
Behavioral: MVPA-Specific Mindfulness Training
type
ACTIVE_COMPARATOR
label
Exp Condition 9
description
Research participant receives the Core Intervention + General Mindfulness Training + Buddy
interventionNames
Behavioral: Core Intervention
Behavioral: General Mindfulness Training
Behavioral: Buddy
type
ACTIVE_COMPARATOR
label
Exp Condition 10
description
Research participant receives the Core Intervention + General Mindfulness Training
interventionNames
Behavioral: Core Intervention
Behavioral: General Mindfulness Training
type
ACTIVE_COMPARATOR
label
Exp Condition 11
description
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy
interventionNames
Behavioral: Core Intervention
Behavioral: MVPA-Specific Mindfulness Training
Behavioral: Buddy
type
ACTIVE_COMPARATOR
label
Exp Condition 12
description
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training
interventionNames
Behavioral: Core Intervention
Behavioral: MVPA-Specific Mindfulness Training
type
ACTIVE_COMPARATOR
label
Exp Condition 13
description
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
interventionNames
Behavioral: Core Intervention
Behavioral: General Mindfulness Training
Behavioral: MVPA-Specific Mindfulness Training
Behavioral: Buddy
type
ACTIVE_COMPARATOR
label
Exp Condition 14
description
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training
interventionNames
Behavioral: Core Intervention
Behavioral: General Mindfulness Training
Behavioral: MVPA-Specific Mindfulness Training
type
ACTIVE_COMPARATOR
label
Exp Condition 15
description
Research participant receives the Core Intervention + Buddy
interventionNames
Behavioral: Core Intervention
Behavioral: Buddy
type
ACTIVE_COMPARATOR
label
Exp Condition 16
description
Research participant receives the Core Intervention
interventionNames
Behavioral: Core Intervention
Primary outcomes (1)
measure
Physical Activity before and after the 12-week technology supported physical activity interventions in young adult cancer survivors
timeFrame
24 weeks
description
Physical activity will be measured at baseline and at 12 and 24 weeks.The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
Secondary outcomes (14)
measure
Physical Function in young adult cancer survivors
timeFrame
24 weeks
description
Symptom burden on physical function will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1.
This 4-item scale uses a 5-point Likert scale (5=without any difficulty to 1=unable to do). The minimum value one can score is 4, and the maximum is 20. The higher scores represent better outcome.
measure
Anxiety in young adult cancer survivors
timeFrame
24 weeks
description
Symptom burden of anxiety will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1.
This 4-item scale measures uses a 5-point Likert scale (1=never to 5=always). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
measure
Depression in young adult cancer survivors
timeFrame
24 weeks
description
Symptom burden of depression will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1.
This 4-item scale uses a 5-point Likert scale (1=never to 5=always). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
measure
Fatigue in young adult cancer survivors
timeFrame
24 weeks
description
Symptom burden of fatigue will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1.
This 4-item scale uses a 5-point Likert scale (1=not at all to 5=very much). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
measure
Sleep Disturbance in young adult cancer survivors
timeFrame
24 weeks
description
Symptom burden of sleep disturbance will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1.
This 4-item scale uses a 5-point Likert scale (1=not at all to 5=very much). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
measure
Sleep Impairment in young adult cancer survivors
timeFrame
24 weeks
description
Symptom burden of sleep disturbance will be measured at baseline and 12 and 24 weeks using the PROMIS Sleep-Related Impairment - Short Form 4a.
This 4-item scale uses a 5-point Likert scale (1=not at all to 5=very much). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
measure
Ability to participate in social roles and activities in young adult cancer survivors
timeFrame
24 weeks
description
Ability to participate in social roles and activities will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1.
This 4-item scale uses a 5-point Likert scale (5=never to 1=always). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
measure
Applied Cognition Abilities in young adult cancer survivors
timeFrame
24 weeks
description
Symptom burden on applied cognitive abilities will be measured at baseline and 12 and 24 weeks using the PROMIS Applied Cognition-Abilities-Short Form 4a.
This 4-item scale uses a 5-point Likert scale (1=not at all to 5=very much). The minimum value one can score is 4, and the maximum is 20. The higher scores represent better outcome.
measure
Pain interference in young adult cancer survivors
timeFrame
24 weeks
description
Pain interference will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1.
This 4-item scale uses a 5-point Likert scale (5=never to 1=always). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome..
measure
Pain intensity in young adult cancer survivors
timeFrame
24 weeks
description
Pain intensity will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1.
This 1-item scale uses a 11-point Likert scale (0=no pain to 10=worst pain imaginable). The minimum value one can score is 0, and the maximum is 10. The lower score represents better outcome..
measure
Leisure Time Physical Activity in young adult cancer survivors
timeFrame
24 weeks
description
Leisure time physical activity will be measured at baseline and 12 and 24 weeks using the Godin Leisure Time Exercise Questionnaire Physical Activity.
This is a measure of self-reported physical activity participation. Participants report "times per week" they participate in strenuous (e.g., jogging), moderate (e.g., fast walking), and mild (e.g., easy walking) exercise over the past 7 days and the "average duration each time you exercised (in minutes)" for each of the three activity categories. Weekly minutes of total, light, moderate, and vigorous activity are calculated by multiplying the frequency and time of each activity. This value is divided by 7 to obtain daily averages. The minimum value one can score is 0, and the maximum depends on the number of self-reported minutes of physical activity. Higher scores indicate better outcome.
measure
Light Intensity Physical Activity
timeFrame
24 weeks
description
Light intensity physical activity will be measured at baseline and at 12 and 24 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
measure
Sedentary Time
timeFrame
24 weeks
description
Sedentary time will be measured at baseline and at 12 and 24 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
measure
Sleep Duration
timeFrame
24 weeks
description
Sleep duration will be measured at baseline and at 12 and 24 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days on their wrist while they sleep.
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