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Alberta Cancer Exercise Pilot Randomized Trial (ACE)

11. Oktober 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Verhalten: Education
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.
Experimental: 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.
Verhalten: Education
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.
Verhalten: Exercise
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.
Andere Namen:
  • Physische Aktivität

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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

Andere Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Alberta

Mitarbeiter

AHS Cancer Control Alberta
University of Calgary

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. April 2015

Primärer Abschluss (Tatsächlich)

1. Dezember 2016

Studienabschluss (Tatsächlich)

30. Juni 2018

Studienanmeldedaten

Zuerst eingereicht

30. Dezember 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Januar 2015

Zuerst gepostet (Schätzen)

5. Januar 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Oktober 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Oktober 2018

Zuletzt verifiziert

1. April 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • HREBA-CC-14-0153

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

No plan in place

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