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PEACH Trial: Prescribed Exercise After Chemotherapy (PEACH)

12 augustus 2011 bijgewerkt door: University of Dublin, Trinity College

Individually Prescribed Exercise Versus Usual Care in a Heterogeneous Cancer Survivor Population: A Pragmatic Randomized Controlled Trial

Many cancer survivors suffer symptoms such as fatigue and dyspnea which may persist for years or months after their chemotherapy has finished. Despite the known benefits of exercise and its potential to address many of the symptoms after cancer, the type of practical exercise programme which best suits this population is not known.

Many exercise programmes performed in cancer survivors take place over many weeks or months and include people with specific types of cancer. Such programmes may therefore not be suitable for the majority of cancer survivors and would pose serious practical difficulties with high drop-out rates and expensive resource consumption if they were extended into clinical practice.

We propose to run an 8-week exercise intervention in a mixed cancer population.

Hypothesis: A brief, individually tailored 8-week intervention will increase fitness and improve other physical symptoms in a mixed cancer survivor population after chemotherapy.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Background: Many cancer survivors suffer a range of physical and psychological symptoms with may persist for years or months after treatment finishes. Despite the known benefits of exercise and its potential to address many of these adverse effects of treatment, the role of exercise as well as its optimum duration, frequency, and intensity in this population has yet to be fully elucidated. Many cancer rehabilitation programmes presented in the literature are very long, have tight eligibility criteria and are not likely to be practical in the majority of cancer survivors. We plan to investigate a novel brief 8-week intervention which aims to increase physical fitness, and address other physical symptoms in a heterogeneous cancer survivor population.

Methods/design: Approximately 60 cancer survivors 2-6 months after completion of chemotherapy, usually adjuvant, with curative intent will be recruited through oncology clinics in a single institution and randomised to usual care or an exercise intervention. The exercise intervention consists of two specifically tailored, supervised, moderate intensity aerobic exercise sessions per week for 8 weeks. All participants will be assessed at baseline (0 weeks), post intervention (8 weeks), and at 3-month follow-up. The primary outcome measure is fitness, and secondary patient-related outcome measures include fatigue, quality of life, and morphological outcomes. A further secondary outcome is process evaluation including adherence to and compliance with the exercise program.

Discussion: This study will provide valuable information about the physical outcomes of this 8-week supervised aerobic programme. Additional process information and economic evaluation will inform the feasibility of implementing this program in a heterogeneous population after chemotherapy treatment with curative intent.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

43

Fase

  • Fase 3

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

  • Ierland
      • Dublin, Ierland, 8
        • Medical Oncology Department, St. James's Hospital

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

21 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Diagnosis of solid tumour and completion of adjuvant chemotherapy (and/or radiotherapy) with curative intent within the preceding 2-6 months. (Patients who have received neoadjuvant chemotherapy or chemoradiotherapy followed by surgery will also be eligible. In addition, patients continuing onto adjuvant hormone therapy and anti-Her2 directed therapy are eligible).
  • Ability to understand English
  • Willing to be randomised
  • Medical clearance to exercise
  • Age 21-69
  • Fitness level average, fair or poor according to certain pre-determined cut-off points for age and gender(Fletcher et al., 2001)
  • Willing and able to attend supervised exercise sessions twice weekly for a period of 8 weeks, with an intention of achieving > 90% attendance
  • LVEF > 50% and not < 20% worse than baseline in applicable patients

Exclusion Criteria:

  • Evidence of active cancer
  • Chronic medical and orthopaedic conditions that would preclude exercise (eg uncontrolled congestive heart failure or angina, recent MI, breathing difficulties requiring oxygen use or hospitalization)
  • On beta-blocker medication
  • Prior history of another cancer in previous 5 years (exception: non-melanoma skin cancer and non-invasive cancer of the cervix)
  • Confirmed pregnancy
  • Dementia or psychiatric illness that would preclude ability to participate in study
  • Incomplete haematological recovery after chemotherapy (WCC< 3, Hb < 10 or Platelets < 100)
  • BMI > 35
  • LVEF post chemotherapy < 50% or > 20% deterioration of baseline pre-systemic treatment. LVEF criteria are applicable in patients who have received chemotherapy deemed in normal clinical practice to have a potential effect LVEF and in whom the LVEF will have been measured before systemic treatment and at end of chemotherapy

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: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Exercise Programme
This will consist of an 8-week exercise programme, performed twice per week.
Gedragsmatig: Exercise programme
Moderate intensity exercise
Placebo-vergelijker: Usual Care
Standard practice including opportunistic exercise advice and patients' self-directed physical activity
Gedragsmatig: Exercise programme
Moderate intensity exercise

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Modified Bruce Treadmill Test (Fitness)
Tijdsspanne: 0, 8 weeks, 3 months
0, 8 weeks, 3 months

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
FACT-G scale (Quality of life-overall)
Tijdsspanne: 0, 8 weeks, 3 months
0, 8 weeks, 3 months
FACT-F (Fatigue)
Tijdsspanne: 0, 8 weeks, 3 months
0, 8 weeks, 3 months
RT3 Accelerometry (Activity level)
Tijdsspanne: 0, 8 weeks, 3 months
0, 8 weeks, 3 months
Tanita Body Fat Assessment (% fat)
Tijdsspanne: 0, 8 weeks, 3 months
0, 8 weeks, 3 months
SF-36v2 (Quality of life-functional aspects)
Tijdsspanne: 0, 8 weeks and 3 months
0, 8 weeks and 3 months

Medewerkers en onderzoekers

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

Sponsor

University of Dublin, Trinity College

Medewerkers

Health Research Board, Ireland

Onderzoekers

  • Hoofdonderzoeker: Dearbhaile O' Donnell, MD, St. James's Hospital, Dublin, Ireland
  • Hoofdonderzoeker: Juliette Hussey, PhD, Trinity College Dublin, Ireland
  • Hoofdonderzoeker: Julie M Walsh, MSc, University of Dublin, Trinity College

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

Nuttige links

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

1 januari 2010

Primaire voltooiing (Werkelijk)

1 augustus 2011

Studie voltooiing (Werkelijk)

1 augustus 2011

Studieregistratiedata

Eerst ingediend

11 december 2009

Eerst ingediend dat voldeed aan de QC-criteria

11 december 2009

Eerst geplaatst (Schatting)

14 december 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

15 augustus 2011

Laatste update ingediend die voldeed aan QC-criteria

12 augustus 2011

Laatst geverifieerd

1 november 2009

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • CTPF/2008/12

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