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Physical Activity for Adolescent and Young Adult Cancer Survivors

2019. május 29. frissítette: Jennifer Brunet, University of Ottawa

Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention

More adolescents and young adults are surviving cancer than ever before. Many endure negative effects related to their cancer and its treatment, which reduces their quality of life and functioning. Physical activity is one strategy that has been shown to promote quality of life amongst cancer survivors. However, very little research has focused on adolescent and young adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is to explore the feasibility, safety, and potential benefits of a 12-week home-based physical activity intervention in adolescent and young adult cancer survivors.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

17

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Kanada
    • Ontario
      • Ottawa, Ontario, Kanada, K1N 6N5
        • University of Ottawa

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

15 év (Gyermek, Felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

INCLUSION CRITERIA:

  1. Have been diagnosed with cancer for the first time between the ages of 15 and 39 years;
  2. Have completed cancer treatment within 5 years;
  3. Currently between the ages of 15 to 44 years;
  4. Have no current evidence of progressive disease, secondary cancer (i.e., cancer cells that have spread from the primary cancer), or second cancers (i.e., a new different cancer);
  5. Live within 100 km of the University of Ottawa;
  6. Be inactive or insufficiently active as determined by a single item screening question (i.e., participants must respond "no" to the following question: are you currently engaging in moderate physical activity, defined as activity that increases your heart rate and causes you to sweat, on 3 or more days a week?). Screening participants based on their level of physical activity will ensure only those individuals for whom the intervention will have the largest effect are recruited;
  7. Able to read, understand, and provide informed consent in English;
  8. Ready for physical activity as indicated by answering Physical Activity Readiness Questions (PAR-Q). If participants are not ready for physical activity as determined by the PAR-Q they will need to complete a Physical Activity Readiness Medical Examination Form.

EXCLUSION CRITERIA:

  1. Physical impairments precluding participation in physical activity;
  2. Unwilling or unable to sign the Participant Informed Consent Form;
  3. Received a diagnosis of brain cancer or thyroid cancer. Brain cancer survivors will be excluded as a function of the cognitive impairments associated with their diagnosis and treatment and thyroid cancer survivors will be excluded due to the vastly different treatment regimens. That is, both of these cancers may result in different physical, psychological/emotional, and social effects that could impact the outcomes of interest.

Eligible participants who want to participate in the other pre-specified outcome measures to assess cognitive functioning must also meet the following additional inclusion/exclusion criteria.

ADDITIONAL INCLUSION CRITERIA:

  1. Right-handedness, because language is lateralized and has been shown to be left side dominant (for right handers) during fMRI tasks;
  2. Able to read, understand, and provide informed consent in English for the additional assessments.

ADDITIONAL EXCLUSION CRITERIA:

  1. Metal implants (e.g., pacemaker) or metal dental work (aside from fillings) that would preclude scanning;
  2. Claustrophobia;
  3. Poor eyesight (not correctable with contact lenses) that precludes viewing stimuli presented in the scanner;
  4. Lower back pain that would preclude a person from lying relatively still for one hour;
  5. Substance use disorder as assessed by a single item question (i.e., participants must respond "no" to the following question: Have you been told, in the last five years, by your healthcare provider that you have a substance use disorder?).

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Támogató gondoskodás
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Physical Activity
Participants in the experimental arm (i.e., physical activity) will be asked to complete the 12-week home-based physical activity program and to complete all study assessments.
Viselkedési: Physical Activity
Participants will receive a 12-week home-based physical activity program that has been individualized using their baseline assessment results. The program will be comprised of aerobic training (2 days/week) and resistance training (2 days/week). The aerobic training will be performed unsupervised. The resistance training will be performed under the supervision of a study team member (who will visit participants homes) for the first 6 weeks to ensure proper form and safety.
Nincs beavatkozás: Wait-List Control
Participants in the no intervention arm (i.e., wait-list control) will be asked to maintain their usual lifestyle activities and to complete all study assessments. Participants in this arm will be provided with the 12-week home-based physical activity program in the exact same way as participants in the experimental arm (i.e., physical activity) at the end of the study.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Recruitment Rates
Időkeret: Through study completion, an average of 12-24 weeks
The number of eligible participants who enrol in the study out of the number who are referred.
Through study completion, an average of 12-24 weeks
Retention Rates
Időkeret: Through study completion, an average of 12-24 weeks
The number of participants completing the intervention and all scheduled assessments.
Through study completion, an average of 12-24 weeks
Adherence Rates
Időkeret: Through study completion, an average of 12-24 weeks
The number of physical activity sessions engaged in out of the total recommended as part of the intervention.
Through study completion, an average of 12-24 weeks
Number of Participants with Adverse Events
Időkeret: Through study completion, an average of 12-24 weeks
The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the physical activity intervention and/or its assessments.
Through study completion, an average of 12-24 weeks

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Physical Activity Behaviour: Daily Physical Activity Logbook
Időkeret: Through study completion, an average of 12-24 weeks
Change in daily self-reported daily physical activity from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
Through study completion, an average of 12-24 weeks
Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
Change in self-reported physical activity (over the past 7 days) from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
Physical Activity Behaviour: 7-Day Accelerometer Wear (Objective Physical Activity Behaviour)
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
Change in objective levels of physical activity as measured by accelerometers (Actigraph wGT3XP-BT), which will be worn for a 7 day period from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
Resting Heart Rate
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in resting heart rate, as measured by a heart rate monitor (Polar A300), from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Blood Pressure
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in resting blood pressure, using a blood pressure monitor (HealthSmart Digital Blood Pressure Monitor), from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Body Composition: Body Mass Index
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in body mass as determined by a Tanita scale (TBF-310 GS) that uses bioelectrical impedance to assess body composition from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Aerobic Capacity: 6-Minute Walk Test (CSEP, 2013; Irwin, 2012)
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Musculoskeletal Strength: Combined Grip Strength using a Handheld Dynamometer (CSEP, 2013; Irwin, 2012)
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Muscular Endurance: 30-Second Sit to Stand Test (Rikli & Jones, 2001)
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in muscular endurance (i.e., number of times participants can stand from a seated position in 30 seconds) from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Self-Efficacy: Single-Item Version of the Exercise Self-Efficacy Scale (McAuley, 1993)
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported self-efficacy from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Physical Competence and Physical Self-Esteem: Physical Self-Description Questionnaire Short-Form Appearance, Strength, Endurance, Body Fat, and Physical Self-Esteem scales (Marsh, Martin, & Jackson, 2010)
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported physical competence and physical self-esteem from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Global Self-Esteem: Rosenberg Global Self-Esteem Scale (Rosenberg, 1965)
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported global self-esteem from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Body Image: Multidimensional Body-Self Relations Questionnaire Appearance Evaluation and Body Areas Satisfaction scales (Cash, 2000)
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported body image from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Posttraumatic Growth: Posttraumatic Growth Inventory (Tedeschi & Calhoun, 1996)
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported posttraumatic growth from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Quality of Life: Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)
Időkeret: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported quality of life from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Participants Experiences: Qualitative Interviews
Időkeret: Baseline (week 0), post-intervention (week 12)
Participants experiences in the intervention (i.e., with physical activity if in the experimental arm or with engaging in their usual lifestyle if in the wait-list control arm) and subsequent changes, if any, in behavioural, physical, psychological, and quality of life outcomes as explored via qualitative interviews (following an interview schedule containing a series of open-ended questions and probes) from baseline to post-intervention.
Baseline (week 0), post-intervention (week 12)

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Cognitive Functioning: Single Open-Ended Question
Időkeret: Baseline (week 0), post-intervention (week 12), follow-up (week 24)

Change in participants responses to a single open-ended question: "Do you ever feel like you have a hard time thinking and/or remembering?" from baseline, to post-intervention, to follow-up.

NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments.
Baseline (week 0), post-intervention (week 12), follow-up (week 24)
Cognitive Functioning: Magnetic Resonance Imaging (MRI) Scans
Időkeret: Baseline (week 0), post-intervention (week 12), follow-up (week 24)

Change in participants cognitive functioning, as assessed by a structural scan, a resting state functional MRI (fMRI) procedure, four fMRI tasks, and a diffusion tensor imaging sequence (lasting approximately 60 minutes), from baseline, to post-intervention, to follow-up.

NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments.
Baseline (week 0), post-intervention (week 12), follow-up (week 24)
Socio-Demographic and Medical Information Questionnaire
Időkeret: Baseline (week 0)
The socio-demographic and medical information collected will be used to describe the sample.
Baseline (week 0)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

University of Ottawa

Nyomozók

  • Kutatásvezető: Jennifer Brunet, PhD, University of Ottawa

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2017. szeptember 11.

Elsődleges befejezés (Tényleges)

2019. április 16.

A tanulmány befejezése (Tényleges)

2019. május 5.

Tanulmányi regisztráció dátumai

Először benyújtva

2016. december 24.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2017. január 6.

Első közzététel (Becslés)

2017. január 11.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2019. május 31.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2019. május 29.

Utolsó ellenőrzés

2019. május 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

Egyéb vizsgálati azonosító számok

  • Ottawa

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

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