Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight
21 febbraio 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
641
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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North Carolina
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Durham, North Carolina, Stati Uniti, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, Stati Uniti, 27710
- Duke Comprehensive Cancer Center
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 65 anni a 120 anni (Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Wait-list control
Wait-list control received diet & exercise counseling during year 2 as a courtesy
|
|
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Sperimentale: Lifestyle counseling
subjects randomized to receive diet & exercise counseling for one year
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: one year
|
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
|
one year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: one year
|
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
|
one year
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Wendy Demark-Wahnefried, PhD, Duke Cancer Institute
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 dicembre 2003
Completamento primario (Effettivo)
1 giugno 2008
Completamento dello studio (Effettivo)
1 maggio 2009
Date di iscrizione allo studio
Primo inviato
15 marzo 2006
Primo inviato che soddisfa i criteri di controllo qualità
15 marzo 2006
Primo Inserito (Stima)
17 marzo 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 febbraio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 febbraio 2017
Ultimo verificato
1 febbraio 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- carcinoma mammario in stadio IV
- carcinoma mammario in stadio IIIA
- carcinoma mammario ricorrente
- carcinoma mammario in stadio IIIB
- cancro alla prostata in stadio III
- cancro alla prostata in stadio IV
- carcinoma prostatico ricorrente
- cancro del retto in stadio IV
- carcinoma del colon in stadio IV
- tumore al colon ricorrente
- carcinoma rettale ricorrente
- cancro al colon in stadio III
- carcinoma mammario in stadio II
- carcinoma mammario in stadio IIIC
- cancro al seno in stadio I
- cancro alla prostata in stadio I
- cancro alla prostata in stadio IIB
- carcinoma della prostata in stadio IIA
- carcinoma del retto in stadio II
- carcinoma del retto in stadio III
- cancro al colon in stadio II
- cancro del retto in stadio I
- cancro al colon in stadio I
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro00012963
- DUMC-5477-03-12R0ER
- DUMC-5477-04-12R1ER
- CDR0000460231 (Altro identificatore: NCI)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .