TY - JOUR
T1 - Baseline characteristics and recruitment for SWOG S1820
T2 - altering intake, managing bowel symptoms in survivors of rectal cancer (AIMS-RC)
AU - Sun, Virginia
AU - Thomson, Cynthia A.
AU - Crane, Tracy E.
AU - Arnold, Kathryn B.
AU - Guthrie, Katherine A.
AU - Freylersythe, Sarah G.
AU - Braun-Inglis, Christa
AU - Jones, Lee
AU - Carmichael, Joseph C.
AU - Messick, Craig
AU - Flaherty, Devin
AU - Ambrale, Samir
AU - Cohen, Stacey A.
AU - Krouse, Robert S.
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/6
Y1 - 2024/6
N2 - Purpose: Many survivors of rectal cancer experience persistent bowel dysfunction. There are few evidence-based symptom management interventions to improve bowel control. The purpose of this study is to describe recruitment and pre-randomization baseline sociodemographic, health status, and clinical characteristics for SWOG S1820, a trial of the Altering Intake, Managing Symptoms in Rectal Cancer (AIMS-RC) intervention. Methods: SWOG S1820 aimed to determine the preliminary efficacy, feasibility, and acceptability of AIMS-RC, a symptom management intervention for bowel health, comparing intervention to attention control. Survivors with a history of cancers of the rectosigmoid colon or rectum, within 6–24 months of primary treatment completion, with a post-surgical permanent ostomy or anastomosis, and over 18 years of age were enrolled. Outcomes included total bowel function, low anterior resection syndrome, quality of life, motivation for managing bowel health, self-efficacy for managing symptoms, positive and negative affect, and study feasibility and acceptability. Results: The trial completed accrual over a 29-month period and enrolled 117 participants from 34 institutions across 17 states and one US Pacific territory. At baseline, most enrolled participants reported self-imposed diet adjustments after surgery, persistent dietary intolerances, and bowel discomfort post-treatment, with high levels of constipation and diarrhea (grades 1–4). Conclusions: SWOG S1820 was able to recruit, in a timely manner, a study cohort that is demographically representative of US survivors of rectal cancer. Baseline characteristics illustrate the connection between diet/eating and bowel symptoms post-treatment, with many participants reporting diet adjustments and persistent inability to be comfortable with dietary intake. ClinicalTrials.gov registration date: 12/19/2019. ClinicalTrials.gov Identifier: NCT#04205955.
AB - Purpose: Many survivors of rectal cancer experience persistent bowel dysfunction. There are few evidence-based symptom management interventions to improve bowel control. The purpose of this study is to describe recruitment and pre-randomization baseline sociodemographic, health status, and clinical characteristics for SWOG S1820, a trial of the Altering Intake, Managing Symptoms in Rectal Cancer (AIMS-RC) intervention. Methods: SWOG S1820 aimed to determine the preliminary efficacy, feasibility, and acceptability of AIMS-RC, a symptom management intervention for bowel health, comparing intervention to attention control. Survivors with a history of cancers of the rectosigmoid colon or rectum, within 6–24 months of primary treatment completion, with a post-surgical permanent ostomy or anastomosis, and over 18 years of age were enrolled. Outcomes included total bowel function, low anterior resection syndrome, quality of life, motivation for managing bowel health, self-efficacy for managing symptoms, positive and negative affect, and study feasibility and acceptability. Results: The trial completed accrual over a 29-month period and enrolled 117 participants from 34 institutions across 17 states and one US Pacific territory. At baseline, most enrolled participants reported self-imposed diet adjustments after surgery, persistent dietary intolerances, and bowel discomfort post-treatment, with high levels of constipation and diarrhea (grades 1–4). Conclusions: SWOG S1820 was able to recruit, in a timely manner, a study cohort that is demographically representative of US survivors of rectal cancer. Baseline characteristics illustrate the connection between diet/eating and bowel symptoms post-treatment, with many participants reporting diet adjustments and persistent inability to be comfortable with dietary intake. ClinicalTrials.gov registration date: 12/19/2019. ClinicalTrials.gov Identifier: NCT#04205955.
KW - Bowel dysfunction
KW - Diet modification
KW - Intervention
KW - Quality of life
KW - Self-management
UR - http://www.scopus.com/inward/record.url?scp=85194018771&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85194018771&partnerID=8YFLogxK
U2 - 10.1007/s00520-024-08527-x
DO - 10.1007/s00520-024-08527-x
M3 - Article
C2 - 38775966
AN - SCOPUS:85194018771
SN - 0941-4355
VL - 32
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
IS - 6
M1 - 371
ER -