SWOG S1820: Altering Intake, Managing Symptoms for bowel dysfunction in survivors of Rectal Cancer (The AIMS-RC intervention trial).
Contemp Clin Trials Commun
; 22: 100768, 2021 Jun.
Article
em En
| MEDLINE
| ID: mdl-33997460
ABSTRACT
OBJECTIVE:
To describe the study protocol of SWOG S1820, a trial of the Altering Intake, Managing Symptoms intervention for bowel dysfunction in survivors of Rectal Cancer (AIMS-RC).DESIGN:
SWOG S1820 is a multi-site, randomized trial of 94 post-treatment survivors of rectal cancer, comparing the intervention and attention control arms.SETTING:
Affiliated institutions of the National Cancer Institute (NCI)-supported National Community Oncology Research Program (NCORP) and the National Clinical Trial Network (NCTN).PARTICIPANTS:
Survivors of rectal cancer who are between 6 and 24 months after treatment completion. INTERVENTION AIMS-RC is a 17-week, 10 session telephone coaching program to help survivors of rectal cancer track their symptoms and improve their diets for better health and bowel function. It includes telephone-based coaching, resource manual, and personalized text/email messaging for motivation in between the telephone sessions. MAIN OUTCOMEMEASURES:
Bowel function, low anterior resection syndrome score, quality of life (QOL), dietary quality, motivation, self-efficacy, positive/negative affect, feasibility, adherence, retention, acceptability.ANALYSIS:
Thirty-seven participants per arm (74 total) provide 80% power to detect this 0.5 standard deviation effect size, based on a two-sample t-test with a 1-sided alpha = 0.1. A total of 94 randomized participants will be accrued to account for 7% ineligibility and 15% attrition at 6 months.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Guideline
Aspecto:
Patient_preference
Idioma:
En
Revista:
Contemp Clin Trials Commun
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Estados Unidos