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Physical Activity for Adolescent and Young Adult Cancer Survivors

29 mei 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

17

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

15 jaar tot 44 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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?).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recruitment Rates
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical Activity Behaviour: Daily Physical Activity Logbook
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cognitive Functioning: Single Open-Ended Question
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline (week 0)
The socio-demographic and medical information collected will be used to describe the sample.
Baseline (week 0)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Ottawa

Onderzoekers

  • Hoofdonderzoeker: Jennifer Brunet, PhD, University of Ottawa

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 september 2017

Primaire voltooiing (Werkelijk)

16 april 2019

Studie voltooiing (Werkelijk)

5 mei 2019

Studieregistratiedata

Eerst ingediend

24 december 2016

Eerst ingediend dat voldeed aan de QC-criteria

6 januari 2017

Eerst geplaatst (Schatting)

11 januari 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 mei 2019

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2019

Laatst geverifieerd

1 mei 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • Ottawa

Plan Individuele Deelnemersgegevens (IPD)

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ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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