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Alberta Cancer Exercise Pilot Randomized Trial (ACE)

11. oktober 2018 oppdatert av: Margie McNeely, University of Alberta

Alberta Cancer Exercise Community-based Program: A Pilot Randomized Controlled Trial

The purpose of the study is to examine the benefit and specific outcomes of a community-based exercise program that is designed to address the needs of individuals who are receiving or recovering from cancer treatment.

Eighty cancer survivors from Edmonton and Calgary will take part in the 24-week long study. Survivors will be randomly assigned to one of two groups. The first group will take part in an 8-week supervised exercise program followed by 8 weeks of self-directed or home-based exercise (early exercise group). The other 40 participants will continue with their normal activities for 16 weeks (delayed exercise group). After the 16 week period, participants in the delayed exercise group will take part in the 8-week supervised exercise program.

Exercise sessions will take place at selected YMCAs in Edmonton and Calgary. Exercise sessions will be supervised by specially trained exercise specialists who have received special training in exercise and cancer.

Outcomes of the study will include feasibility, physical fitness measures, cancer-related symptoms and quality of life.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Purpose: The primary purpose of this proposed study is to pilot test the planned Alberta Cancer Exercise (ACE) program evaluation components at the level of the individual cancer survivor. These components include program reach as well as effectiveness as determined by outcomes of physical fitness, symptoms, and quality of life. This proposed study will enable us to formalize an evaluation strategy to inform effectiveness and implementation of the ACE program.

Methods: A randomized controlled trial (RCT) design will be utilized to examine the short-term effectiveness of the proposed community-based cancer exercise program designed for cancer survivors. The study will take place at the Cross Cancer Institute/University of Alberta and Tom Baker Cancer Centre/ University of Calgary as well as in selected YMCA community fitness centres in Edmonton and Calgary. The exercise intervention will be delivered by specially trained exercise professionals who have completed the formal cancer exercise education course. Eighty participants will be randomized to early (intervention group) or delayed community-based exercise programming (standard care group). Participants randomized to the intervention group will undertake the ACE Program at a selected Edmonton and Calgary YMCA for an 8-week period. Following the 8-week supervised intervention period, participants will have the option to continue on a 'fee for service' basis or to continue with self-directed exercise at home. Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period. The standard care group will be offered participation in the 8-week ACE program at the completion of the 16-week follow-up period.

Outcomes: The primary outcome is program feasibility: recruitment, completion and adherence rates. For the purposes of the proposed study and the length of follow-up of 24 weeks, the RE-AIM components of Reach, Effectiveness and Implementation at the level of the individual will be evaluated as potential outcome indicators for the ACE program. Outcomes will include measures of health-related physical fitness, cancer-related symptoms and quality of life.

Summary: ACE is an active living initiative, encouraging cancer survivors in Alberta to take a role in their own wellbeing by supporting participation in cancer-specific community-based exercise programs.

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary/ Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6J4P9
        • University of Alberta/ Cross Cancer Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Within 18 months of a diagnosis of any type of cancer
  2. Receiving or have received curative cancer treatment (e.g., surgery, chemotherapy, radiation therapy)
  3. Cleared for unrestricted physical activity by their treating oncologist

Exclusion Criteria:

  1. Presence of metastatic disease
  2. Any uncontrolled or serious comorbid conditions that would preclude participation in exercise testing and training
  3. Women who are pregnant

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Standard Care
Participants in this group will receive standard education on the importance of physical activity in the recovery from cancer and how to become more active. Participants assigned to this group will have the option to participate in the exercise program after the 16-week follow-up assessment.
Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period.
Eksperimentell: Supervised Community-based Exercise
Participants in this group will take part in an 8-week supervised exercise program at the YMCA. Following the 8-week intervention, participants will have the option to continue for an additional 8-weeks at the YMCA (fee for service) or follow an 8-week self-directed program.
Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period.
The participant exercise sessions will be conducted in small groups of 5 to 10 participants under the direct supervision of the community-based exercise specialist. Participants will have the choice between taking part in a bridging exercise class (e.g., Beauty program and Bridging to Fitness - Cancer) or group-based supervised fitness centre exercise training.
Andre navn:
  • Fysisk aktivitet

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility: number of participants completing the objective outcome measurements for the study
Tidsramme: 24 weeks
Proportion of subjects completing the physical fitness tests including aerobic capacity, musculoskeletal fitness and body composition measurements.
24 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Aerobic Capacity
Tidsramme: 8 weeks
Change in submaximal aerobic exercise capacity (treadmill, bike or 6 minute walk test)
8 weeks
Health-related Quality of Life
Tidsramme: 8 weeks
Change in quality of life: Functional Assessment of Cancer Therapy General Questionnaire
8 weeks
Symptom Assessment
Tidsramme: 8 weeks
Change in symptoms: Memorial Symptom Assessment Scale
8 weeks
Adherence to exercise
Tidsramme: 24 weeks
Attendance at supervised exercise sessions
24 weeks
Recruitment rate
Tidsramme: 18 months
Number of participants consenting to the study divided by the number of eligible participants
18 months
Upper Extremity Muscular Strength (optional)
Tidsramme: 8 weeks
Change in 8 repetition maximum strength of chest press
8 weeks
Upper Extremity Grip Strength (optional)
Tidsramme: 8 weeks
Hand Grip strength
8 weeks
Lower Extremity Muscular Strength (optional)
Tidsramme: 8 weeks
Change in 8 repetition maximum strength of leg press
8 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adverse Events rate
Tidsramme: 24 weeks
Number of serious and minor adverse events
24 weeks
Program Costs
Tidsramme: 24 months
Costs related to study personnel, fitness centre costs and participant related costs
24 months
Body composition
Tidsramme: 8 weeks
Body mass index
8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2015

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

30. juni 2018

Datoer for studieregistrering

Først innsendt

30. desember 2014

Først innsendt som oppfylte QC-kriteriene

2. januar 2015

Først lagt ut (Anslag)

5. januar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. oktober 2018

Sist bekreftet

1. april 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • HREBA-CC-14-0153

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No plan in place

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