A randomized prospective trial of an ostomy telehealth intervention for cancer survivors.

BACKGROUND: Cancer survivors with ostomies face complex challenges. This study compared the Ostomy Self-Management Telehealth program (OSMT) versus attention control usual care (UC). METHODS: Three academic centers randomized participants. OSMT group sessions were led by ostomy nurses and peer ostomates (three for ostomates-only, one for support persons, and one review session for both). Surveys at baseline, OSMT completion, and 6 months were primary outcome patient activation (PAM), self-efficacy (SE), City of Hope quality of life-Ostomy (COH-O), and Hospital Anxiety and Depression Scale (HADS). Surveys were scored per guidelines for those completing at least two surveys. Linear mixed effects models were used to select potential covariates for the final model and to test the impact of OSMT within each timeframe. RESULTS: A total of 90 OSMT and 101 UC fulfilled analysis criteria. Arms were well-matched but types of tumors were unevenly distributed (p = .023). The OSMT arm had a nonsignificant improvement in PAM (confidence interval [CI], -3.65 to 5.3]; 4.0 vs. 2.9) at 6 months. There were no significant differences in other surveys. There was a significant OSMT benefit for urinary tumors (four SE domains). Higher OSMT session attendance was associated with post-session improvements in five SE domains (p < .05), two COH-O domains (p < .05), and HADS anxiety (p = .01). At 6 months, there remained improvements in one SE domain (p < .05), one COH-O domain (p < .05), and HADS anxiety (p < .01). CONCLUSIONS: No clear benefit was seen for the OSMT intervention, although there may be an advantage based on type of tumor. Benefit with greater session attendance was also encouraging. PLAIN LANGUAGE SUMMARY: Cancer patients with ostomies have many challenges. We tested a telehealth curriculum compared to usual care. There are indications of benefit for the program for those that attend more sessions and those with urostomies.

Intimacy and survivors of cancer with ostomies: findings from the Ostomy Self-management Training trial.

BACKGROUND: Many people with abdominal or pelvic cancers require an ostomy during surgical treatment, which can cause significant issues with physical and emotional intimacy in relationships. AIM: To evaluate the effect of a telehealth-based education program on intimacy over time for survivors of cancer with ostomies. METHODS: We performed a secondary analysis of our multicenter randomized controlled trial to determine intimacy outcomes and to compare the effects of the Ostomy Self-management Training (OSMT) program vs usual care. Partnered patients were included who provided answers to the City of Hope Quality of Life-Ostomy survey for at least 2 time points during the study. We evaluated the effect of baseline information, such as gender on intimacy. OUTCOMES: The primary outcome was intimacy, estimated by a composite score created from questions within the City of Hope Quality of Life-Ostomy survey. RESULTS: Of 216 enrolled volunteers, 131 had a partner: 68 in the OSMT arm and 63 in the usual care arm. Of these, 48 were women and 83 were men. The tumor types represented in this study were colorectal (n = 69), urinary (n = 45), gynecologic (n = 10), and other (n = 7; eg, melanoma, liposarcoma). From the cohort, 87 answered the 5 composite intimacy score questions at 2 time points, including baseline. There was significant improvement over time in composite intimacy scores for participants in the OSMT arm vs the usual care arm. CLINICAL IMPLICATIONS: Our OSMT intervention had a positive effect on factors that contribute to intimacy for survivors of cancer with ostomies, suggesting that a survivorship curriculum can improve their experiences after ostomy surgery. STRENGTHS AND LIMITATIONS: OSMT allowed for discussion of intimacy and other sensitive topics, which can be challenging. These discussions demonstrate benefit to participants and can serve as frameworks for cancer treatment providers. The focus of this work on partnered participants provides insight into the interpersonal challenges of a life with an ostomy, but it may overlook the important perspectives of nonpartnered participants and the partners themselves. Furthermore, limited power prevented us from conducting subgroup analyses exploring the effects of factors such as gender and tumor type on intimacy. CONCLUSION: At 6-month follow-up, the novel intimacy composite score indicated improvement for participants completing the OSMT intervention. Future research studies with higher power will validate this intimacy measurement and identify intimacy differences in similar populations based on tumor type.

Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial.

BACKGROUND: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. METHODS: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450. FINDINGS: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). INTERPRETATION: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. FUNDING: Agency for Healthcare Research and Quality and the National Cancer Institute. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Clinical and Demographic Differences Among Cancer Survivors With Ostomies With and Without Informal Caregivers.

Informal caregivers have an essential role for cancer survivors (CS). There may be important clinical and demographic differences between CS with ostomies based on caregiver status. Our aim was to identify items that may lead to future recommendations and interventions for CS with ostomies. This is a secondary analysis of 216 CS with ostomies that were enrolled in a clinical trial. Baseline data collected included demographics, clinical characteristics, and surveys (patient activation, self-efficacy, City of Hope Quality of Life - Ostomy). These factors were compared based on caregiver status using chi-squared analysis and t-tests. Logistic regression was used to examine the factors that affect the likelihood of having a caregiver. Most participants had an identified caregiver (57%; 124/216). There was no difference in age based on caregiver status (mean 64.4 and 62.0 for those with and without a caregiver, respectively). Of those with a caregiver, 66.9% were males, 79.0% were partnered, and 87.1% were white. Those with caregivers had a higher prevalence of diabetes (p < 0.001), heart disease (p = 0.002), and mobility issues (p = 0.002). Survivors with caregivers had both higher incomes (p = 0.012) and levels of education (p = 0.049). The only difference in survey measures was those with a caregiver were more successful at getting help when needed (p = .045). Differences in gender and comorbidities of CS with caregivers demand further investigation. Interventions such as encouraging CS without caregivers to utilize available sources of social support, including other survivors with ostomies, may improve their care and quality of life.

Self-management goals of cancer survivors with an ostomy.

OBJECTIVES: Ostomies due to cancer surgery impose complex and enduring care challenges that necessitate cancer survivors" self-management. The objective of this analysis is to evaluate ostomates' self- management goals using a qualitative approach. METHODS: A multi-site randomized controlled trial testing the Ostomy Self-Management Training program (OSMT) was delivered via telehealth to a group of cancer survivors with an ostomy randomized to either the OSMT program with goal setting or usual care (UC), without goal setting. Goals were classified by type and frequency according to a modified City of Hope Health-Related Quality of Life framework (physical, psychological, social, spiritual, ostomy-specific, and healthcare quality domains), using a directed and systematic content analysis approach. RESULTS: The 524 self-management goals analyzed by domain frequencies physical (29.4%), ostomy specific (29.0%) and social well-being (25.0%) were predominant. Managing other health issues (7.6%), psychological issues (6.0%), and spiritual well-being issues (3.0%) were next. Common self-management themes were ostomy care independence (87.5%), handling cancer-related issues (62.5%), achieving acceptance (56.2%), resuming physical activity (43.0%), and maintaining fluid/diet balance (43.0%). DISCUSSION/CONCLUSION: Goal-setting offers insights into self-management concerns of cancer survivors with ostomies. Results demonstrate the broad aspects of self-management ostomates face. PRACTICE IMPLICATIONS: Self-management training with patient goal-setting may be used to help ostomates with cancer and their health care providers identify areas for needed education and support.

Adapting to the burdens of care: a telehealth program for cancer survivors with ostomies.

PURPOSE: An ostomy introduces to cancer survivors new demands for self-care and healthcare resource use. A curriculum that teaches ostomates self-management skills may affect survivors' use of resources. METHODS: A prospective randomized trial comparing usual care (UC) with an Ostomy Self-Management Training (OSMT) program delivered by telehealth was conducted in patients with ostomies due to cancer. The intervention occurred over 5 weeks with survey administration at baseline, program completion, and 6 months after completion. Quantitative data were analyzed using a mixed-effects logistic model to predict mean values of resource and service use. Responses to the open-ended question were coded and analyzed with directed content analysis. RESULTS: One hundred and sixty-seven subjects (89 in the OSMT arm and 78 in the UC arm) completed the questionnaire at all time points. The changes in likelihoods of emptying one's ostomy bag > 8 times/week and of incurring any out-of-pocket costs on accessories were 14% greater for the intervention group (p = .029 and p = .063, respectively). Qualitative analysis reveals among the OSMT arm an increase in the proportion of ostomy-specific comments and a decrease in the same metric among the UC arm. Common themes included learning to work with equipment, dealing with gas build-up and finding well-fitting clothing. CONCLUSIONS: There are some indications that participants in this structured telehealth program are more active in ostomy self-care. The reported ostomy self-care activities, healthcare consumables, and healthcare services reported by both groups illustrate the complexity of survivorship care following ostomy surgery. National Clinical Trial Identifier: NCT02974634.

Stakeholder engagement and participation in the design, delivery, and dissemination of the ostomy self-management telehealth (OSMT) program.

PURPOSE: Stakeholder engagement is increasingly integrated into clinical research processes. We conducted a mixed methods analysis to describe stakeholders' (peer ostomates, ostomy nurses, telehealth engineers) perceptions of their engagement and participation in a multisite, randomized trial of a telehealth-delivered curriculum for cancer survivors with ostomies. METHODS: Stakeholder notes were analyzed using narrative analysis. We constructed a 15-item survey that assessed the following areas: adherence to stakeholder engagement principles, engagement/influence throughout the study process, impact on perceived well-being, and satisfaction. Stakeholders were invited to complete the survey anonymously. Quantitative survey data were tabulated through summary statistics. RESULTS: Across intervention sessions, an average of 7.7 ± 1.4 stakeholders attended and 2.6 ± 1.4 submitted a note per session. The survey response rate was 73% (11/15). Stakeholders reported high agreement that the study adhered to engagement principles (91% reciprocal relationships, 100% co-learning, partnership, and transparency/honesty/trust). They felt highly engaged (18% moderate, 73% great deal) and that they had influence on study initiation (27% moderate, 55% great deal), intervention delivery (9% moderate, 82% great deal), fidelity assessment (18% moderate, 73% great deal), analysis and interpretation (55% moderate, 27% great deal), and dissemination (45% moderate, 45% great deal). They reported high overall satisfaction with roles (91% great deal), believed the program was helpful for participants (91%), and that serving on study team benefited their own well-being (100%). CONCLUSIONS: Our strategy of stakeholder inclusion led to high engagement, input, satisfaction, and belief in success of program, which could be mirrored in other trials.

Stoma location and ostomy-related quality of life among cancer survivors with ostomies: A pooled analysis.

INTRODUCTION: We sought to explore how stoma location may affect self-care events and health-related quality of life (HRQOL) in cancer survivors with ostomies. METHODS: A pooled dataset was obtained from three multi-site studies that used the City of Hope Quality of Life-Ostomy questionnaire. Predicted means for HRQOL and individual items were generated adjusting for sex, ostomy type, and body mass index. RESULTS: Among 607 cancer survivors, abdominal quadrant groups were: 138 (23%) upper left, 298 (49%) lower left, 51 (8%) upper right, and 120 (20%) lower right. Survivors with lower right side ostomies more frequently reported weight gain after ostomy surgery (p < 0.001). Stoma on the right side of the abdomen was associated with lower scores for issues with the skin surrounding the ostomy (p = 0.03) and satisfaction with appearance (p = 0.008). DISCUSSION: Stoma location is associated with HRQOL and difficulties adjusting to the ostomy.

Cancer survivors' greatest challenges of living with an ostomy: findings from the Ostomy Self-Management Telehealth (OSMT) randomized trial.

OBJECTIVES: An ostomy results in lifelong quality of life changes for a cancer survivor. We describe the greatest challenges reported from a randomized trial of cancer survivors with stomas (ostomies). METHODS: Cancer survivors with ostomies participating in a multi-site randomized prospective trial of an Ostomy Self-Management Telehealth (OSMT) program versus usual care (UC) were surveyed at six months post accrual. An open-ended question requested greatest challenges after ostomy surgery. Quantitative descriptive and qualitative analyses were used to examine greatest challenges reported. RESULTS: A total of 118 trial participants identified greatest challenges with 55 in the OSMT and 63 in the UC. Six conceptual domains were used to code comments-physical, psychological, social, and spiritual quality of life; ostomy-specific issues, and healthcare issues. The OSMT contributed 187 comments, and UC contributed 235 comments. Ostomy specific issues and social well-being had the most comments overall with UC contributing more comments in all domains except physical well-being. Word Clouds revealed post-operative and treatment-related issues and going out in public as the most common challenges in both groups. Word Clouds compared types of ostomies revealing bowel function challenges (colostomy group), difficulties going out in public (ileostomy group), and positive support (urostomy group). CONCLUSIONS: Fewer challenges submitted by the OSMT group provide the beginning evidence of the OSMT program impact. Dominant challenges across both groups were social well-being and ostomy care. Challenges varied by type of ostomy. Findings support long-term care and support for all cancer survivors with ostomies. TRIAL REGISTRATION: NCT02974634.

Programmatic Costs of the Telehealth Ostomy Self-Management Training: An Application of Time-Driven Activity-Based Costing.

OBJECTIVES: Programmatic cost assessment of novel clinical interventions can inform their widespread dissemination and implementation. This study aimed to determine the programmatic costs of a telehealth Ostomy Self-Management Training (OSMT) intervention for cancer survivors using Time-Driven Activity-Based Costing (TDABC) methodology. METHODS: We demonstrated a step-by-step application of TDABC based on a process map with core OSMT intervention activities and associated procedures and determined resource use and costs, per unit procedure. We also assessed per-patient costs from a payer perspective and provided estimates of total hours and costs by personnel, activity, and procedure. RESULTS: The per-patient cost of the OSMT was $1758. Personnel time accounted for 91% of the total cost. Site supervisor and information technology technician time were the most expensive personnel resources. Telehealth technical and communication equipment accounted for 8% of the total cost. Intervention coordination and monitoring efforts represented most of the total time cost (62%), followed by the intervention delivery (35%). The procedures with the highest cost were communication via phone or virtual meetings (24%), email exchanges (18%), and telehealth session delivery (18%). CONCLUSIONS: Future efforts to replicate, disseminate, and implement the OSMT intervention should anticipate funding for nonclinical components of the intervention, including coordination and monitoring, and consider how these activities can be performed most efficiently. For institutions without established telemedicine programs, selection of videoconferencing platforms and adequate staffing for participant technical support should be considered. Our step-by-step application of TDABC serves as a case study demonstrating how interventionists can gather data on resource use and costs of intervention activities concurrently with their collection of trial data.

An Ostomy Self-management Telehealth Intervention for Cancer Survivors: Technology-Related Findings From a Randomized Controlled Trial.

BACKGROUND: An Ostomy Self-management Telehealth (OSMT) intervention by nurse educators and peer ostomates can equip new ostomates with critical knowledge regarding ostomy care. A telehealth technology assessment aim was to measure telehealth engineer support requirements for telehealth technology-related (TTR) incidents encountered during OSMT intervention sessions held via a secure cloud-based videoconferencing service, Zoom for Healthcare. OBJECTIVE: This paper examines technology-related challenges, issues, and opportunities encountered in the use of telehealth in a randomized controlled trial intervention for cancer survivors living with a permanent ostomy. METHODS: The Arizona Telemedicine Program provided telehealth engineering support for 105 OSMT sessions, scheduled for 90 to 120 minutes each, over a 2-year period. The OSMT groups included up to 15 participants, comprising 4-6 ostomates, 4-6 peer ostomates, 2 nurse educators, and 1 telehealth engineer. OSMT-session TTR incidents were recorded contemporaneously in detailed notes by the research staff. TTR incidents were categorized and tallied. RESULTS: A total of 97.1% (102/105) OSMT sessions were completed as scheduled. In total, 3 OSMT sessions were not held owing to non-technology-related reasons. Of the 93 ostomates who participated in OSMT sessions, 80 (86%) completed their OSMT curriculum. TTR incidents occurred in 36.3% (37/102) of the completed sessions with varying disruptive impacts. No sessions were canceled or rescheduled because of TTR incidents. Disruptions from TTR incidents were minimized by following the TTR incident prevention and incident response plans. CONCLUSIONS: Telehealth videoconferencing technology can enable ostomates to participate in ostomy self-management education by incorporating dedicated telehealth engineering support. Potentially, OSMT greatly expands the availability of ostomy self-management education for new ostomates. TRIAL REGISTRATION: ClinicalTrials.gov NCT02974634; https://clinicaltrials.gov/ct2/show/NCT02974634.

Adaptation of the City of Hope-Quality of Life-Ostomy Questionnaire From English to Brazilian Portuguese: A Validation Study.

PURPOSE: To culturally adapt the City of Hope-Quality of Life-Ostomy Questionnaire (COH-QOL-OQ) from English to Brazilian Portuguese and evaluate psychometric properties of the adapted instrument (internal consistency and construct validity). DESIGN: Methodological study to establish reliability and validity. SUBJECTS AND SETTING: The sample comprised 215 persons with stomas of any etiology who attended 1 of 3 specialized outpatient care center and 2 associations for persons with ostomies. Participants were residents of the state of Rio Grande do Sul, located in southeastern Brazil. METHODS: Techniques for cultural adaptation were carried out based on recommendations from the literature. We then evaluated the instrument's psychometric properties. Specifically, we evaluated construct (convergent and discriminant) validity and concurrent criterion validity via comparison of the adapted version of COH-QOL-OQ versus the WHOQOL-Bref (World Health Organization Quality of Life instrument). We also evaluated the internal consistency of the adapted COH-QOL-OQ, a measure of reliability. RESULTS: The internal consistency of the items was high with a Cronbach α of 0.92 for the total score and values ranging from 0.79 to 0.86 for the various domains of the COH-QOL-OQ. Confirmatory factorial analysis identified adjustment indexes to the acceptable model of adjustment for the COH-QOL-OQ model. Strong correlations between the COH-QOL-OQ and WHOQOL-Bref instrument domains confirmed the validity of the convergent construct. For the analysis of the concurrent criterion validity, the correlation coefficients between the score of item 16 and the other domains of COH-QOL-OQ ranged from 0.26 to 0.66. Analysis of the discriminate validity indicated that it was possible to isolate groups based on the temporal character of the stoma and time since ostomy surgery. CONCLUSIONS: The adapted version of COH-QOL-OQ demonstrates construct (convergent and discriminant) validity, concurrent criterion validity, and internal consistency (a measure of reliability) for evaluating health-related quality of life of persons with ostomies living in Brazil.

Healthy behaviors are associated with positive outcomes for cancer survivors with ostomies: a cross-sectional study.

BACKGROUND: Cancer survivors (CS) with ostomies may face challenges in sustaining physical activity (PA) levels and maintaining healthy diets. This analysis describes lifestyle behaviors and their relationships with health-related quality of life (HRQOL) in CS with ostomies. METHODS: This is a cross-sectional, secondary analysis of a multisite randomized self-management education trial for CS with ostomies. The baseline self-reported measures were queried on aerobic PA and diet using the City of Hope Quality of Life Ostomy measure, and the Self-Efficacy to Perform Self-Management Behaviors questionnaire (SE). PA was compared against the American Cancer Society PA guidelines for CS. Relationships between PA and HRQOL were evaluated using multiple linear regression, stratified by BMI. RESULTS: Among 200 responders, fewer than 20% met or exceeded the PA guideline for cancer survivors; overall, confidence in the ability to perform gentle or aerobic PA was moderate (6/10 on the SE). Overall HRQOL (p = 0.038), psychological well-being (p = 0.017), and physical strength (p = 0.025) were associated with increased PA. Almost half (48.7%) of CS reported a special diet. CS with urostomies were less likely to report diet adjustments after their ostomy surgeries (OR: 0.16, 95% CI [0.08-0.38]) than CS with fecal ostomies. CONCLUSIONS: Better HRQOL is associated with PA guideline achievement among CS with ostomies. Additionally, diet adjustments were reported more frequently in CS with fecal ostomies. Our findings bear clinical relevance for designing ostomy self-management and lifestyle recommendations for CS with ostomies. IMPLICATIONS FOR CANCER SURVIVORS: The evaluation of lifestyle behaviors may be an especially important focus for CS with ostomies.

Intellectual Equipoise and Challenges: Accruing Patients With Advanced Cancer to a Trial Randomizing to Surgical or Nonsurgical Management (SWOG S1316).

BACKGROUND: Prospective, randomized trials are needed to determine optimal treatment approaches for palliative care problems such as malignant bowel obstruction (MBO). Randomization poses unique issues for such studies, especially with divergent treatment approaches and varying levels of equipoise. We report our experience accruing randomized patients to the Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (SWOG S1316) study, comparing surgical and nonsurgical management of MBO. METHODS: Patients with MBO who were surgical candidates and had treatment equipoise were accrued and offered randomization to surgical or nonsurgical management. Patients choosing nonrandomization were offered prospective observation. Trial details are listed on www.clinicaltrials.gov (NCT #02270450). An accrual algorithm was developed to enhance enrollment. RESULTS: Accrual is ongoing with 176 patients enrolled. Most (89%) patients chose nonrandomization, opting for nonsurgical management. Of 25 sites that have accrued to this study, 6 enrolled patients on the randomization arm. Approximately 59% (20/34) of the randomization accrual goal has been achieved. Patient-related factors and clinician bias have been the most prevalent reasons for lack of randomization. An algorithm was developed from clinician experience to aid randomization. Using principles in this tool, repeated physician conversations discussing treatment options and goals of care, and a supportive team-approach has helped increase accrual. CONCLUSIONS: Experience gained from the S1316 study can aid future palliative care trials. Although difficult, it is possible to randomize patients to palliative studies by giving clinicians clear recommendations utilizing an algorithm of conversation, allotment of necessary time to discuss the trial, and encouragement to overcome internal bias.

Cancer Survivorship at the Intersections of Care and Personhood.

Surviving colorectal cancer following ostomy surgery with an intestinal stoma presents numerous challenges to the cultural category of full adult personhood. The foremost is managing unpredictable bowel activity. The technical management of the ostomy facilitated by biomedical specialists, is essential for personhood realignment. This article focuses on how some female long-term cancer survivors manage and adapt to this new fecal habitus by mobilizing various assemblages of care - receiving care, continuing to provide particular gendered forms of care, and returning to caregiving roles. These interdependent practices of care realign personhood, or at the very least, minimize the assaults that having an ostomy presents to the cultural category of full adult personhood.

The effect of multiple recruitment contacts on response rates and patterns of missing data in a survey of bladder cancer survivors 6 months after cystectomy.

PURPOSE: The Bladder Cancer Quality of Life Study collected detailed and sensitive patient-reported outcomes from bladder cancer survivors in the period after bladder removal surgery, when participation in survey research may present a burden. This paper describes the study recruitment methods and examines the response rates and patterns of missing data. METHODS: Detailed surveys focusing on quality of life, healthcare decision-making, and healthcare expenses were mailed to patients 5-7 months after cystectomy. We conducted up to 10 follow-up recruitment calls. We analyzed survey completion rates following each contact in relation to demographic and clinical characteristics, and patterns of missing data across survey content areas. RESULTS: The overall response rate was 71% (n = 269/379). This was consistent across patient clinical characteristics; response rates were significantly higher among patients over age 70 and significantly lower among racial and ethnic minority patients compared to non-Hispanic white patients. Each follow-up contact resulted in marginal survey completion rates of at least 10%. Rates of missing data were low across most content areas, even for potentially sensitive questions. Rates of missing data differed significantly by sex, age, and race/ethnicity. CONCLUSIONS: Despite the effort required to participate in research, this population of cancer survivors showed willingness to share detailed information about quality of life, health care decision-making, and expenses, soon after major cancer surgery. Additional contacts were effective at increasing participation. Response patterns differed by race/ethnicity and other demographic factors. Our data collection methods show that it is feasible to gather detailed patient-reported outcomes during this challenging period.

Cancer survivors' challenges with ostomy appliances and self-management: a qualitative analysis.

PURPOSE: An ostomy poses significant health-related quality of life (HRQOL) issues for cancer survivors. Survivors must learn to manage pouching appliances and adjust to the psychosocial consequences of living with an ostomy. We explored, through qualitative analysis, the challenges with self-management and ostomy appliances reported by cancer survivors. METHODS: Pooled data from two studies with a question on the greatest challenge of living with an ostomy and intervention session notes were analyzed using content analysis approach. The themes were reviewed and agreed upon by the research team, and counts were tallied for each theme based on the number of times they were mentioned by participants. RESULTS: Of the 928 greatest challenge responses and session notes, a total of 106 mentions (11%) were focused on ostomy appliances, associated repercussions, and time taken for ostomy care. Eight themes emerged: bleeding, pain, leakage, skin problems/irritation/rash, wafer-related issues, materials getting under the wafer, time to care for ostomy, and solutions to clean the stoma. Challenges described included poor wafer adherence, allergic reactions to adhesives, and pain around the stoma site. These challenges resulted in anxiety related to leakage, odor, and/or skin irritation, which negatively impacted on participation in social activities and self-confidence with ostomy care. CONCLUSIONS: Cancer survivors living with an ostomy experience multiple obstacles with ostomy appliances and caring for their ostomy. Continued innovation in ostomy appliance design and technology is needed to help cancer survivors with successfully managing ostomy care.

The City of Hope Quality of Life Stoma Questionnaire: Malayalam Translation and Validation.

BACKGROUND: Malayalam is the language spoken by 38.5 million people worldwide. There is no specific instrument to measure stoma-related quality of life (QOL) in Malayalam language. AIM: This study was designed to translate and validate the city of hope QOL (COH-QOL) Ostomy Questionnaire, which is a robust tool developed in English language. MATERIALS AND METHODS: The instrument was translated to Malayalam, abiding by internationally accepted translation methodology. Trained interviewer (first author) administered the questionnaire to patients with stoma, who were visiting the stoma clinic. The reliability of the subscales and the total scores were established by calculating correlation coefficients. Convergent and divergent validity were evaluated by calculating Pearson's correlations of each item with its own scale and other scales. RESULTS: Cronbach's alpha coefficients for all subscales were 0.70 or more. Similarly, split-half coefficients also were more than 0.70, which were acceptable. All subscales met the minimum acceptable standards of convergent and discriminant validity. Discriminant validity of all scores was less than convergent validity which suggests that there was no overlap between various constructs in measuring the same traits. The validation study of Malayalam translation of COH stoma questionnaire has shown that the tool is valid and reliable. CONCLUSION: The validation study of Malayalam translation of City of Hope Stoma questionnaire has shown the tool is valid and reliable.

Using the RE-AIM framework for dissemination and implementation of psychosocial distress screening.

OBJECTIVE: To evaluate the RE-AIM framework's effect on retention of participants and implementation outcomes of a 5-year cancer research education programme on psychosocial distress screening in cancer centres across the United States. METHODS: A one-group pre-/post-test design was used to evaluate the programme on participant retention and implementation outcomes at 6, 12 and 24 months after enrolling in the programme (baseline) and analysed using descriptive statistics. RESULTS: Seventy-two cancer centres participated in four cohorts. Participant retention was 100%. At baseline and 24 months, respectively, 52 (72%) and 64 (88%) of the cancer centres had formulated a psychosocial distress screening policy; 51 (71%) and 70 (98%) had started screening in more than one clinic/population; 15 (21%) and 45 (63%) had started auditing health records for documentation of screening. Each outcome rate improved at the cancer-centre level over the 24 months. CONCLUSION: RE-AIM can be used as a framework for cancer research education programmes. Future research is needed on the use of a randomised adaptive design to test the optimal support for implementation of quality care standards according to cancer centres' needs.

Using the Dermatology Life Quality Index to Assess How Breast Radiodermatitis Affects Patients' Quality of Life.

PURPOSE: The purpose of this study is to report the initial validation process for using the Dermatology Life Quality Index (DLQI) for radiodermatitis of the breast. METHODS: This is an additional analysis of a study designed to report a longitudinal study in skin-related and global quality of life in women with breast radiodermatitis. A total of 40 participants completed the DLQI instrument weekly while receiving external radiotherapy of the female breast. At week 5 on treatment, 31 (78%) participants provided narrative feedback on how each DLQI item affected her life. Agreement between participant DLQI numerical ratings and narrative feedback on items was assessed. Construct validity was estimated using principal component analysis (PCA). Internal consistency of the DLQI was assessed using Cronbach alpha. RESULTS: Percentage of agreement between participant DLQI ratings and narratives ranged from 71% to 98%. Each participant responded "no" to the work and study item leading to zero variance and removal from our analyses. Principal component analysis supported the inclusion of all of the remaining items. The DLQI with nine remaining items demonstrated moderately good internal consistency (α = .69). CONCLUSIONS: The results of our examination of the DLQI when used for breast radiodermatitis are promising. Next steps include additional larger studies among more diverse populations.