SWOG S1820: A pilot randomized trial of the Altering Intake, Managing Bowel Symptoms Intervention in Survivors of Rectal Cancer.

BACKGROUND: Survivors of rectal cancer experience persistent bowel dysfunction after treatments. Dietary interventions may be an effective approach for symptom management and posttreatment diet quality. SWOG S1820 was a pilot randomized trial of the Altering Intake, Managing Symptoms in Rectal Cancer (AIMS-RC) intervention for bowel dysfunction in survivors of rectal cancer. METHODS: Ninety-three posttreatment survivors were randomized to the AIMS-RC group (N = 47) or the Healthy Living Education attention control group (N = 46) after informed consent and completion of a prerandomization run-in. Outcome measures were completed at baseline and at 18 and 26 weeks postrandomization. The primary end point was total bowel function score, and exploratory end points included low anterior resection syndrome (LARS) score, quality of life, dietary quality, motivation, self-efficacy, and positive/negative affect. RESULTS: Most participants were White and college educated, with a mean age of 55.2 years and median time since surgery of 13.1 months. There were no statistically significant differences in total bowel function score by group, with the AIMS-RC group demonstrating statistically significant improvements in the exploratory end points of LARS (p = .01) and the frequency subscale of the bowel function index (p = .03). The AIMS-RC group reported significantly higher acceptability of the study. CONCLUSIONS: SWOG S1820 did not provide evidence of benefit from the AIMS-RC intervention relative to the attention control. Select secondary end points did demonstrate improvements. The study was highly feasible and acceptable for participants in the National Cancer Institute Community Oncology Research Program. Findings provide strong support for further refinement and effectiveness testing of the AIMS-RC intervention.

Baseline characteristics and recruitment for SWOG S1820: altering intake, managing bowel symptoms in survivors of rectal cancer (AIMS-RC).

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. GOV REGISTRATION DATE: 12/19/2019. GOV IDENTIFIER: NCT#04205955.

Methodology for Analyzing Qualitative Data in Multiple Languages.

BACKGROUND: Translation strategies are commonly used for qualitative interview data to bridge language barriers. Inconsistent translation of interviews can lead to conceptual inequivalence, where meanings of participants' experiences are distorted, threatening scientific rigor. OBJECTIVES: Our objective is to describe a systematic method developed to analyze multilingual, qualitative interview data while maintaining the original language of the transcripts. METHODS: A literature review of translation strategies, cross-language, and multilingual qualitative research was conducted. Combined with criteria for qualitative content analysis and trustworthiness, the methodology was developed and used for a qualitative descriptive study. RESULTS: The study had interview data in both English and Spanish. The research team consisted of both native Spanish and English speakers, who were grouped based on language. Verbatim transcription of data occurred in the original languages. All codes were kept in English, allowing the research team to view the data set as a whole. Two researchers within each group coded each transcript independently before reaching a consensus. The entire research team discussed all transcripts, and finally, major themes were determined. Participants' quotes remained in the original language for publication, with an English translation included when needed. DISCUSSION: Analyzing transcripts in the original language brought forth cultural themes that otherwise may have been overlooked. This methodology promotes conceptual equivalence and trustworthiness that is paramount in cultural, linguistic, and social determinants of health research to advance health equity.

Barriers and facilitators for adopting a healthy lifestyle among Latina cancer survivors: A qualitative descriptive study.

PURPOSE: Cancer is the leading cause of death among Hispanics/Latinos in the USA. Latina cancer survivors experience higher symptom burden than other cancer survivors. A healthy lifestyle can decrease recurrent cancer risk, increase well-being, and may decrease symptom burden in cancer survivors. The purpose of this study was to explore the barriers and facilitators for adopting healthy lifestyle behaviors among Latina cancer survivors. METHODS: Using the Health Belief Model as the theoretical framework, qualitative descriptive methodology was used for secondary analysis of data from a previously conducted randomized clinical trial. Transcripts from the telephone health coaching calls, analyzed in the original language (English or Spanish), were used for this qualitative analysis. RESULTS: Intervention telephone call transcript data from Latina cancer survivors (n = 14) were analyzed. Major themes were as follows: Perceived susceptibility to other chronic illnesses, perceived benefits of a healthy lifestyle, and perceived barriers and facilitators of adopting a healthy lifestyle. Lack of knowledge about healthy lifestyle behaviors could prevent participants from adopting a healthy lifestyle; gaining new knowledge about healthy lifestyle behaviors was a facilitator for changing lifestyle. Family responsibility and wearable technology could both prevent and motivate the participants to adopt a healthy lifestyle. CONCLUSION: Developing culturally appropriate interventions for Latina cancer survivors is vital to decrease symptom burden and health risks, as well as improve health outcomes in this population.

Exercise and nutrition to improve cancer Treatment-Related outcomes (ENICTO).

Chemotherapy treatment-related side-effects are common and increase the risk of suboptimal outcomes. Exercise interventions during cancer treatment improve self-reported physical functioning, fatigue, anxiety, and depression, but it is unclear whether these interventions improve important clinical outcomes, such as chemotherapy relative dose intensity (RDI). The National Cancer Institute funded the Exercise and Nutrition to Improve Cancer Treatment-Related Outcomes (ENICTO) Consortium, to address this knowledge gap. This paper describes the mechanisms hypothesized to underpin intervention effects on clinically-relevant treatment outcomes, briefly outlines each project's distinct research aims, summarizes the scope and organizational structure of ENICTO, and provides an overview of the integrated common data elements used to pursue research questions collectively. In addition, the paper includes a description of consortium-wide activities and broader research community opportunities for collaborative research. Findings from the ENICTO Consortium have the potential to accelerate a paradigm shift in oncology care such that cancer patients could receive exercise and nutrition programming as the standard of care in tandem with chemotherapy to improve RDI for a curative outcome.

Feasibility and Acceptability of a Text Message Intervention to Promote Adherence to Nutrition and Physical Activity Guidelines in a Predominantly Hispanic Sample of Cancer Survivors and Their Informal Caregivers: Results from a Pilot Intervention Trial.

Hispanic cancer survivors face unique barriers to meeting American Cancer Society (ACS) nutrition and physical activity guidelines, which reduce the risk of cancer recurrence and mortality and improve quality of life. This pilot intervention trial evaluated the feasibility and acceptability of a two-week ACS guideline-based nutrition and physical activity text message intervention in a predominantly Hispanic sample of cancer survivors and their informal caregivers. A mixed methods approach was used to assess feasibility and acceptability of the intervention. Feasibility and acceptability were measured by meeting a-priori cut-offs of >80% for recruitment, retention, and text message response rate. Participants also completed a semi-structured exit interview by telephone that assessed intervention components. Thirteen cancer survivors and six caregivers (n = 19) participated in this pilot study; 78% self-identified as Hispanic. Mean time since treatment completion for survivors was 11.9 years (SD 8.4), and 67% had breast cancer. Cancer survivors had a higher acceptability rate for physical activity (94%) compared to nutrition messages (86%), whereas equal acceptability rates were observed for both types of messages among caregivers (91%). Texting interventions are a feasible, acceptable, and a cost-effective strategy that have the potential to promote lifestyle behavior change among Hispanic cancer survivors and caregivers.

Altering Intake and Managing Symptoms: Feasibility of a Diet Modification Intervention for Post-Treatment Bowel Dysfunction in Rectal Cancer.

BACKGROUND: Bowel dysfunction is a common long-term effect of rectal cancer treatment that affects a survivor's quality of life, with few empirically based interventions for symptom management. OBJECTIVES: The objective was to determine the acceptability of diet modification for bowel dysfunction in postsurgical rectal cancer survivors. METHODS: 11 rectal cancer survivors who were at least six months post-treatment and reported moderate to severe bowel symptoms completed 10 telephone coaching sessions focusing on diet and symptom management over four months. Feasibility was assessed by study enrollment rate and intervention completion rate. FINDINGS: Diet modification coaching for bowel symptom management is feasible for post-treatment rectal cancer survivors. The intervention can be evaluated for efficacy because of potential to serve as a scalable and accessible approach for effective bowel symptom management.

Design and implementation of a health messaging protocol employed for use within a COVID-19 health dissemination platform.

Introduction: AZCOVIDTXT, a bilingual, two-way information sharing platform was created in April of 2020 in response to rising COVID-19 cases in Arizona. The aim of this paper is to delineate the protocol and processes used to develop and disseminate health messaging to serve as guidance for other groups, universities, or public health programs in the implementation or enhancement of health communication services. Methods: Health messaging formats included website articles, published on the system's website (azcovidtxt.org), infographics posted on social media, and SMS. Social media and SMS infographics were intended to highlight and augment the topics covered in the weekly website articles, to create a seamless multimodal source of reliable COVID-19 information for AZCOVIDTXT enrollees and the broader public. All health messaging information, text message and social media content was planned and reviewed collaboratively by the AZCOVIDTXT team topic experts for accuracy, efficacy, and content consistency. Results: As of July 2021, AZCOVIDTXT provided weekly COVID-19-related health communication to 3,747 participating households located across 225 Arizona zip codes. AZCOVIDTXT has developed and sent 446 unique, bilingual SMS for a total of 271,977 contact points. The team has produced and published 179 website articles, which averaged a combined 7,000-page views per month, and 173 social media posts were made available to 268 followers across three platforms. Discussion: Several programmatic aspects were deemed essential to the success of AZCOVIDTXT. These included (1) addressing community specific needs, (2) creating timely and relevant content, (3) developing an adaptable system, and (4) prioritizing system automation where possible, (5) having an interdisciplinary team approach to identifying and crafting key messages.

SWOG S1820: Altering Intake, Managing Symptoms for bowel dysfunction in survivors of Rectal Cancer (The AIMS-RC intervention trial).

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 OUTCOME MEASURES: 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.

Lifestyle intervention for Latina cancer survivors and caregivers: the Nuestra Salud randomized pilot trial.

PURPOSE: Assess feasibility, acceptability, and preliminary efficacy of an integrated symptom management and lifestyle intervention (SMLI) to improve adherence to the American Cancer Society's (ACS) Guidelines on Nutrition and Physical Activity in Latina cancer survivors and their informal caregivers (dyads). METHODS: Forty-five dyads were randomized to a 12-week telephone-delivered intervention or attention control. Intervention effects on nutrition, physical activity, symptom burden, and self-efficacy for symptom management were estimated using Cohen's ds. RESULTS: Mean age was 64 for survivors and 53 for caregivers. Feasibility was demonstrated by the 63% consent rate out of approached dyads. The SMLI was acceptable for 98% of dyads. Among survivors, medium-to-large effect sizes were found for increased servings of total fruits and vegetables (d = 0.55), vegetables (d = 0.72), and decreased sugar intake (d = - 0.51) and medium clinically significant effect sizes for total minutes of physical activity per week (d = 0.42) and grams of fiber intake per day (d = 0.40) for intervention versus attention control. Additionally, medium-to-large intervention effects were found for the reduction of symptom burden (d = 0.74). For caregivers, medium-to-large intervention effects were found for reduced total sugar intake (d = - 0.60) and sugar intake from sugar-sweetened beverages (d = - 0.65); vegetable intake was increased with a medium effect size (d = 0.41). CONCLUSION: SMLI was feasible and acceptable for both dyadic members. A larger, well-powered trial is needed to formally evaluate SMLI effectiveness. IMPLICATIONS FOR CANCER SURVIVORS: Integrating symptom management with lifestyle behavior interventions may increase adherence to the ACS guidelines on nutrition and physical activity to prevent new and recurrent cancers.