IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Rationale, design and methods.
Black or African American
/ education
Aged
Breast Neoplasms
/ ethnology
Cancer Survivors
/ education
Exercise
Female
Health Education
/ organization & administration
Health Status
Humans
Physical Functional Performance
Quality of Life
Research Design
Self-Help Groups
Socioeconomic Factors
White People
/ education
Randomized Controlled Trials as Topic
African American
Cancer exercise
Older breast
socioeconomic status-disadvantaged
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
received:
18
11
2019
revised:
24
03
2020
accepted:
13
04
2020
pubmed:
19
4
2020
medline:
5
8
2021
entrez:
19
4
2020
Statut:
ppublish
Résumé
African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS) are more likely to experience poor functional and health outcomes. However, few studies have evaluated the putative beneficial effects of exercise on these outcomes in older racial minority and SES-disadvantaged BCS. This is a mixed-methods study that includes a randomized-controlled trial, "IMPROVE", to evaluate a group-based exercise intervention compared to a support group program in older BCS, followed by post-intervention semi-structured interviews to evaluate the intervention. The trial aims to recruit 220 BCS with 55 in each of four strata defined by race (AA versus Non-Hispanic Whites) and SES (disadvantaged vs. non-disadvantaged). Participants are ≥65 years old and within five years of treatment completion for stage I-III breast cancer. Participants are randomized to a 52-week, three sessions/week, one-hour/session, moderate intensity aerobic and resistance group exercise intervention, (n = 110) or a 52-week, one hour/week, support group intervention [attention-control arm], (n = 110). The first 20 weeks of both programs are supervised and the last 32 weeks, unsupervised. The primary outcome is the change in Short Physical Performance Battery (SPPB) Scores at 20 weeks from baseline, between the two arms. Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms. Results of the trial may contribute to a better understanding of factors associated with recruitment, and acceptability, and will inform future exercise programs to optimally improve health outcomes for older BCS.
Sections du résumé
BACKGROUND
African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS) are more likely to experience poor functional and health outcomes. However, few studies have evaluated the putative beneficial effects of exercise on these outcomes in older racial minority and SES-disadvantaged BCS.
METHODS
This is a mixed-methods study that includes a randomized-controlled trial, "IMPROVE", to evaluate a group-based exercise intervention compared to a support group program in older BCS, followed by post-intervention semi-structured interviews to evaluate the intervention. The trial aims to recruit 220 BCS with 55 in each of four strata defined by race (AA versus Non-Hispanic Whites) and SES (disadvantaged vs. non-disadvantaged). Participants are ≥65 years old and within five years of treatment completion for stage I-III breast cancer. Participants are randomized to a 52-week, three sessions/week, one-hour/session, moderate intensity aerobic and resistance group exercise intervention, (n = 110) or a 52-week, one hour/week, support group intervention [attention-control arm], (n = 110). The first 20 weeks of both programs are supervised and the last 32 weeks, unsupervised. The primary outcome is the change in Short Physical Performance Battery (SPPB) Scores at 20 weeks from baseline, between the two arms. Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms.
DISCUSSION
Results of the trial may contribute to a better understanding of factors associated with recruitment, and acceptability, and will inform future exercise programs to optimally improve health outcomes for older BCS.
Identifiants
pubmed: 32304828
pii: S1551-7144(20)30079-3
doi: 10.1016/j.cct.2020.106001
pmc: PMC7325580
mid: NIHMS1585824
pii:
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106001Subventions
Organisme : NIMHD NIH HHS
ID : R01 MD009699
Pays : United States
Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
Références
J Clin Epidemiol. 2004 Jun;57(6):571-9
pubmed: 15246125
Nurs Res. 2012 Sep-Oct;61(5):342-52
pubmed: 22699941
J Am Geriatr Soc. 2003 Mar;51(3):314-22
pubmed: 12588574
Am Psychol. 1992 Sep;47(9):1102-14
pubmed: 1329589
Support Care Cancer. 2012 Oct;20(10):2511-21
pubmed: 22252545
Psychopharmacol Bull. 1988;24(4):609-14
pubmed: 3074322
J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31
pubmed: 10811152
Diabetes Care. 2000 Jan;23(1):57-63
pubmed: 10857969
J Gerontol. 1988 Sep;43(5):S153-61
pubmed: 2971088
J Clin Oncol. 2012 Jul 1;30(19):2354-61
pubmed: 22614994
Chest. 1996 Aug;110(2):325-32
pubmed: 8697828
J Clin Oncol. 2011 Dec 10;29(35):4647-53
pubmed: 22067407
Psychooncology. 2009 Apr;18(4):429-39
pubmed: 19117329
J Pain Symptom Manage. 1997 Feb;13(2):63-74
pubmed: 9095563
Phys Ther. 2001 Jun;81(6):1192-205
pubmed: 11380275
J Psychiatr Res. 1975 Nov;12(3):189-98
pubmed: 1202204
JAMA. 2010 Dec 22;304(24):2699-705
pubmed: 21148134
Am J Med. 2003 Feb 15;114(3):180-7
pubmed: 12637131
J Biopharm Stat. 2001 Feb-May;11(1-2):9-21
pubmed: 11459446
Aging (Milano). 1999 Dec;11(6):367-72
pubmed: 10738851
Med Sci Sports Exerc. 2010 Jul;42(7):1409-26
pubmed: 20559064
Cancer. 2014 Jul 15;120(14):2174-82
pubmed: 24911404
Med Sci Sports Exerc. 1997 Jun;29(6 Suppl):S1-205
pubmed: 9243481
JAMA. 1993 May 12;269(18):2386-91
pubmed: 8479064
Am J Public Health. 2002 Aug;92(8):1244-5
pubmed: 12144976
JAMA. 1963 Sep 21;185:914-9
pubmed: 14044222
J Hand Ther. 2005 Oct-Dec;18(4):426-7, quiz 428
pubmed: 16271690
J Am Geriatr Soc. 2008 Nov;56(11):2045-52
pubmed: 19016938
J Am Geriatr Soc. 2005 May;53(5):762-70
pubmed: 15877550
J Am Geriatr Soc. 2009 Nov;57 Suppl 2:S289-92
pubmed: 20122020
J Am Geriatr Soc. 2009 Nov;57(11):2070-6
pubmed: 19793154
J Clin Epidemiol. 2002 Sep;55(9):916-21
pubmed: 12393080
J Clin Oncol. 2016 Feb 20;34(6):611-35
pubmed: 26644543
J Psychosoc Oncol. 2019 Jul-Aug;37(4):413-426
pubmed: 30614422
J Cancer Surviv. 2013 Mar;7(1):20-31
pubmed: 23232922
J Am Geriatr Soc. 2019 May;67(5):920-927
pubmed: 30146695
Cancer. 2016 Aug 15;122(16):2579-86
pubmed: 27348765
Ann Behav Med. 2001 Fall;23(4):229-46
pubmed: 11761340
JAMA Surg. 2018 Dec 1;153(12):1090-1096
pubmed: 30167636
Gerontologist. 2004 Jun;44(3):401-7
pubmed: 15197294
Surg Gynecol Obstet. 1989 Oct;169(4):349-51
pubmed: 2781451
Breast Cancer Res Treat. 2015 Sep;153(2):253-61
pubmed: 26303657
Health Psychol. 2005 May;24(3):235-45
pubmed: 15898858
JAMA. 2013 Jul 24;310(4):389-97
pubmed: 23917289
J Clin Oncol. 1997 Mar;15(3):974-86
pubmed: 9060536
CA Cancer J Clin. 2017 Sep;67(5):378-397
pubmed: 28763097
Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7
pubmed: 12091180
J Consult Clin Psychol. 1983 Jun;51(3):390-5
pubmed: 6863699
Res Q Exerc Sport. 2004 Mar;75(1):92-101
pubmed: 15532365
Cancer Causes Control. 2011 Mar;22(3):427-35
pubmed: 21184262
Med Sci Sports Exerc. 2004 May;36(5):868-75
pubmed: 15126723
Res Q Exerc Sport. 1992 Mar;63(1):60-6
pubmed: 1574662
Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1153-61
pubmed: 23576689
J Chronic Dis. 1987;40(5):373-83
pubmed: 3558716
J Natl Cancer Inst. 2012 Jun 6;104(11):815-40
pubmed: 22570317
Med Sci Sports Exerc. 1982;14(5):377-81
pubmed: 7154893
J Geriatr Oncol. 2018 May;9(3):235-242
pubmed: 29306608
CA Cancer J Clin. 2019 Sep;69(5):363-385
pubmed: 31184787
Med Sci Sports Exerc. 2014 Jul;46(7):1375-83
pubmed: 24389524
MMWR Morb Mortal Wkly Rep. 2013 May 3;62(17):326-30
pubmed: 23636025
Am J Health Promot. 1997 Sep-Oct;12(1):38-48
pubmed: 10170434
J Obstet Gynecol Neonatal Nurs. 2008 Mar-Apr;37(2):203-13
pubmed: 18336444
Diabetes Care. 2007 Feb;30(2):318-24
pubmed: 17259501
Cancer. 2013 Nov 1;119(21):3839-46
pubmed: 24114615
Am J Epidemiol. 1985 Jan;121(1):91-106
pubmed: 3964995
Psychooncology. 2015 Jan;24(1):40-6
pubmed: 24839264
Stat Med. 2006 Jan 15;25(1):143-63
pubmed: 16025541
J Geriatr Oncol. 2018 Nov;9(6):613-619
pubmed: 29699938
Am J Health Promot. 1995 Jul-Aug;9(6):430-2
pubmed: 10150534
Exerc Sport Sci Rev. 2009 Oct;37(4):165-70
pubmed: 19955865
Res Q Exerc Sport. 2004 Jun;75(2):186-96
pubmed: 15209337
CA Cancer J Clin. 2019 May;69(3):211-233
pubmed: 30762872
J Gerontol. 1993 May;48(3):S94-101
pubmed: 8482831
J Geriatr Oncol. 2017 Sep;8(5):356-362
pubmed: 28743505
Cancer Epidemiol Biomarkers Prev. 2018 Feb;27(2):146-153
pubmed: 29141853
Psychopharmacol Bull. 1988;24(4):709-11
pubmed: 3249773
Res Nurs Health. 1994 Feb;17(1):3-13
pubmed: 8134609
J Am Geriatr Soc. 2006 Mar;54(3):507-11
pubmed: 16551321
J Gerontol A Biol Sci Med Sci. 2000 Dec;55(12):M750-6
pubmed: 11129398
Cancer Prev Res (Phila). 2011 Apr;4(4):522-9
pubmed: 21464032
Breast Cancer Res Treat. 2012 Jan;131(2):637-43
pubmed: 21935600
JAMA. 2009 May 13;301(18):1883-91
pubmed: 19436015
Arch Intern Med. 2001 Nov 26;161(21):2602-7
pubmed: 11718592
J Psychosom Res. 1998 Jul;45(1):5-13
pubmed: 9720850
Am J Epidemiol. 1985 Nov;122(5):794-804
pubmed: 3876763
Health Psychol. 1992;11(6):386-95
pubmed: 1286658
Contemp Clin Trials. 2009 May;30(3):233-45
pubmed: 19171204
Med Sci Sports Exerc. 2004 Sep;36(9):1484-91
pubmed: 15354027
Sleep Med. 2012 Jan;13(1):36-42
pubmed: 22033120
Lymphology. 2010 Sep;43(3):118-27
pubmed: 21226414
Diabet Med. 2002 Jul;19(7):527-34
pubmed: 12099954
Med Oncol. 2011 Sep;28(3):753-65
pubmed: 20411366