Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight
21. februar 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
641
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, Forenede Stater, 27710
- Duke Comprehensive Cancer Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år til 120 år (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Wait-list control
Wait-list control received diet & exercise counseling during year 2 as a courtesy
|
|
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Eksperimentel: Lifestyle counseling
subjects randomized to receive diet & exercise counseling for one year
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: one year
|
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
|
one year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: one year
|
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
|
one year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Wendy Demark-Wahnefried, PhD, Duke Cancer Institute
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Cohen HJ. Promoting healthy lifestyles in older cancer survivors to improve health and preserve function. J Am Geriatr Soc. 2009 Nov;57 Suppl 2(Suppl 2):S262-4. doi: 10.1111/j.1532-5415.2009.02507.x.
- Morey MC, Blair CK, Sloane R, Cohen HJ, Snyder DC, Demark-Wahnefried W. Group trajectory analysis helps to identify older cancer survivors who benefit from distance-based lifestyle interventions. Cancer. 2015 Dec 15;121(24):4433-40. doi: 10.1002/cncr.29684. Epub 2015 Oct 29.
- Mosher CE, Sloane R, Morey MC, Snyder DC, Cohen HJ, Miller PE, Demark-Wahnefried W. Associations between lifestyle factors and quality of life among older long-term breast, prostate, and colorectal cancer survivors. Cancer. 2009 Sep 1;115(17):4001-9. doi: 10.1002/cncr.24436.
- Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Miller PE, Hartman TJ, Cohen HJ. Reach out to enhance wellness home-based diet-exercise intervention promotes reproducible and sustainable long-term improvements in health behaviors, body weight, and physical functioning in older, overweight/obese cancer survivors. J Clin Oncol. 2012 Jul 1;30(19):2354-61. doi: 10.1200/JCO.2011.40.0895. Epub 2012 May 21.
- Miller PE, Morey MC, Hartman TJ, Snyder DC, Sloane R, Cohen HJ, Demark-Wahnefried W. Dietary patterns differ between urban and rural older, long-term survivors of breast, prostate, and colorectal cancer and are associated with body mass index. J Acad Nutr Diet. 2012 Jun;112(6):824-31, 831.e1. doi: 10.1016/j.jand.2012.02.021.
- Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
- Snyder DC, Morey MC, Sloane R, Stull V, Cohen HJ, Peterson B, Pieper C, Hartman TJ, Miller PE, Mitchell DC, Demark-Wahnefried W. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009 Apr;18(4):429-39. doi: 10.1002/pon.1491.
- Winger JG, Mosher CE, Rand KL, Morey MC, Snyder DC, Demark-Wahnefried W. Diet and exercise intervention adherence and health-related outcomes among older long-term breast, prostate, and colorectal cancer survivors. Ann Behav Med. 2014 Oct;48(2):235-45. doi: 10.1007/s12160-014-9598-7.
- Blair CK, Morey MC, Desmond RA, Cohen HJ, Sloane R, Snyder DC, Demark-Wahnefried W. Light-intensity activity attenuates functional decline in older cancer survivors. Med Sci Sports Exerc. 2014 Jul;46(7):1375-83. doi: 10.1249/MSS.0000000000000241.
- Miller P, Demark-Wahnefried W, Snyder DC, Sloane R, Morey MC, Cohen H, Kranz S, Mitchell DC, Hartman TJ. Dietary supplement use among elderly, long-term cancer survivors. J Cancer Surviv. 2008 Sep;2(3):138-48. doi: 10.1007/s11764-008-0060-3. Epub 2008 Jul 11.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2003
Primær færdiggørelse (Faktiske)
1. juni 2008
Studieafslutning (Faktiske)
1. maj 2009
Datoer for studieregistrering
Først indsendt
15. marts 2006
Først indsendt, der opfyldte QC-kriterier
15. marts 2006
Først opslået (Skøn)
17. marts 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. februar 2017
Sidst verificeret
1. februar 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- stadium IV brystkræft
- stadium IIIA brystkræft
- tilbagevendende brystkræft
- stadium IIIB brystkræft
- stadium III prostatacancer
- stadium IV prostatacancer
- tilbagevendende prostatakræft
- stadium IV endetarmskræft
- stadium IV tyktarmskræft
- tilbagevendende tyktarmskræft
- tilbagevendende endetarmskræft
- stadium III tyktarmskræft
- stadium II brystkræft
- stadium IIIC brystkræft
- stadium I brystkræft
- stadium I prostatakræft
- stadium IIB prostatacancer
- stadium IIA prostatacancer
- stadium II endetarmskræft
- stadium III endetarmskræft
- stadium II tyktarmskræft
- stadium I endetarmskræft
- stadium I tyktarmskræft
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00012963
- DUMC-5477-03-12R0ER
- DUMC-5477-04-12R1ER
- CDR0000460231 (Anden identifikator: NCI)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .