The overall purpose of this proposal is to conduct a Phase II randomized controlled trial (RCT) of a telephone- based, multimodal diet modification intervention (Altering Intake, Managing Symptoms ? AIMS) to manage bowel dysfunction and improve QOL in 88 rectal cancer survivors, comparing intervention and attention control arms. This research is critical because bowel dysfunction is the most common and feared survival related side effect for rectal cancer survivors, and bowel symptoms result in reduced social activities, poor social well- being, and decrements in quality of life (QOL). Importantly, bowel symptoms are modifiable; however, there is a lack of knowledge on empirically-based interventions to manage bowel dysfunction. Based on the Motivation and Problem-Solving (MAPS) approach of skills training and motivational interviewing, AIMS is a telephone- based symptom management model for rectal cancer survivorship. The intervention incorporates social cognitive theory of behavior change that is operationalized through motivational interviewing techniques to deliver behavior-based, dietary interventions for symptom management. The intervention includes ten telephone sessions (20-40 minutes each) and a resource manual. It is administered to survivors who are 6-24 months after treatment completion. We will pilot test the intervention using a two-group, randomized Phase II design to pursue the following specific aims:
Specific Aim 1 : Assess the feasibility, retention, and satisfaction of the AIMS intervention as measured by the percentage of survivors who a) agree to participate; b) complete ?80% of the intervention; and c) report satisfaction with the intervention (structured exit interviews);
Specific Aim 2 : Determine the preliminary efficacy of AIMS on survivor outcomes;
and Specific Aim 3 : Evaluate sex as a biological variable through analysis of sex differences in study enrollment, retention, and satisfaction as well as change in bowel function, QOL and diet quality score. This proposal is innovative because it promotes symptom science through personalized behavior change strategies and collaborative, innovative, interdisciplinary symptom science research. We will conduct this R21 in SWOG, a National Cancer Institute (NCI)-supported National Clinical Trial Network (NCTN) and National Community Oncology Research Program (NCORP) base. We will use the findings from this R21 to further refine and develop the design, infrastructure, and implementation strategy of a future Phase III trial. Our long-term objective is to conduct a multi-site, Phase III trial of the intervention to establish effectiveness.
The overall purpose of this study is to pilot test a telephone-based, multimodal dietary intervention to manage bowel dysfunction and improve QOL for rectal cancer survivors. This research is needed because bowel dysfunction is one of the most common and feared side effect of rectal cancer treatment, and it leads to poor quality of life for survivors. The ultimate goal of the study is improve the quality of long-term survivorship for rectal cancer survivors.
