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Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight

21 februari 2017 uppdaterad av: Duke University

RENEW: Reach Out to Enhance Wellness in Older Survivors

RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

OBJECTIVES:

Primary

  • Compare the physical function over 1 year of overweight older long-term cancer survivors assigned to immediate vs delayed exercise and dietary counseling.

Secondary

  • Compare physical activity, saturated fat and vegetable and fruit intake, body mass index, depression, and general health and well being of experimental arm patients vs control arm patients.
  • Evaluate self-efficacy, social support, comorbidity, cancer-type, and gender as factors associated with program efficacy.
  • Determine the functional decline over a 2-year period in patients who undergo immediate vs delayed intervention.
  • Characterize the mathematical form, over a 2-year period, of physical functioning trajectories among older cancer survivors, including determining if the intervention effects are durable in those who receive the intervention initially and whether "catch-up" is possible in the delayed intervention arm.

OUTLINE: This is a randomized study. Patients are stratified according to cancer type (colorectal vs breast or prostate), sex, age (65-74 years vs 75 years and over), and race (white vs non-white). Patients are randomized to 1 of 2 intervention arms.

  • Arm I (immediate intervention): Patients receive a personalized notebook of diet and exercise information, exercise equipment, and logbooks to record food intake and exercise behaviors. Patients undergo 20-minute telephone discussions with a health counselor once weekly for 3 weeks, every 2 weeks for 2 months, and then monthly for up to 1 year for a total of 15 sessions. Patients also undergo a 5-minute telephone survey to assess health every 3 months.
  • Arm II (delayed intervention): Patients undergo intervention as in arm I after a 1-year waiting period.

After completion of study intervention, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 640 patients will be accrued for this study.

Studietyp

Interventionell

Inskrivning (Faktisk)

641

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27705
        • Veterans Affairs Medical Center - Durham
      • Durham, North Carolina, Förenta staterna, 27710
        • Duke Comprehensive Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år till 120 år (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

DISEASE CHARACTERISTICS:

  • Diagnosed colorectal, prostate, or female breast cancer

    • At least 5 years beyond date of diagnosis with no clinical evidence of progressive disease or second primaries
  • Body mass index ≥ 25 kg/m^2 and < 40 kg/m^2
  • Currently exercising < 150 minutes/week
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified

  • No serious intercurrent medical condition or disability that could preclude study treatment, including any of the following:

    • Severe orthopedic condition or scheduled hip or knee replacement within the next 6 months
    • Paralysis
    • End-stage renal disease
    • Dementia
    • Unstable angina
    • Heart attack, congestive heart failure, or pulmonary condition that required oxygen or hospitalization within the past 6 months
  • Ability to read, write, and speak English

PRIOR CONCURRENT THERAPY:

  • No concurrent warfarin

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Wait-list control
Wait-list control received diet & exercise counseling during year 2 as a courtesy
Experimentell: Lifestyle counseling
subjects randomized to receive diet & exercise counseling for one year
Beteende: behavioral dietary and exercise intervention

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion
Tidsram: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion
Tidsram: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Physical activity as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) at baseline and years 1 and 2 following study completion
Tidsram: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion
Tidsram: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion
Tidsram: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion
Tidsram: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Self-efficacy for exercise and dietary change assessed by self-efficacy algorithms at baseline and years 1 and 2 following study completion
Tidsram: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Stage of readiness for exercise and dietary change as assessed by the stage of change algorithms at baseline and years 1 and 2 following study completion
Tidsram: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Duke University

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Studiestol: Wendy Demark-Wahnefried, PhD, Duke Cancer Institute

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2003

Primärt slutförande (Faktisk)

1 juni 2008

Avslutad studie (Faktisk)

1 maj 2009

Studieregistreringsdatum

Först inskickad

15 mars 2006

Först inskickad som uppfyllde QC-kriterierna

15 mars 2006

Första postat (Uppskatta)

17 mars 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 februari 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 februari 2017

Senast verifierad

1 februari 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pro00012963
  • DUMC-5477-03-12R0ER
  • DUMC-5477-04-12R1ER
  • CDR0000460231 (Annan identifierare: NCI)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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