E-Health self-management intervention for oral and oropharyngeal cancer survivors: design and single-arm pilot study of empowered survivor.
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ABSTRACT: Background
Self-management regimens for oral and oropharyngeal cancer survivors can be complex and challenging. Effective self-management skills can foster better outcomes. We report on the development, feasibility, and pilot testing of a web-based self-management tool called "Empowered Survivor" (ES) for survivors of oral and oropharyngeal cancer.Methods
ES content was developed in two phases, with modules focusing on oral care, swallowing and muscle strength, and long-term follow-up. This single-arm pilot study consisted of a pre-, 2-month, and a 6-month postintervention survey.Results
Enrollment rates were relatively low. Once enrolled, data collected from the ES website indicated that 81.8% viewed ES. Participants provided positive evaluations of ES. Preliminary results indicate that ES had a beneficial impact on self-management self-efficacy, preparedness for survivorship care, and quality of life. ES improved survivors' engagement in oral self-exams and head and neck strengthening exercises, improved ability to address barriers, and decreased information and support needs.Conclusions
This study provides preliminary evidence of engagement, acceptability, and beneficial impact of ES, which should be evaluated in a larger controlled clinical trial.
SUBMITTER: Manne S
PROVIDER: S-EPMC9247862 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundSurvivors of oral cavity and oropharyngeal cancer frequently experience difficulties in swallowing; tasting; speaking; chewing; and maintaining comfortable movements of the head, neck, and shoulder. Engagement in regular self-care can reduce further loss of function and mitigate late effects. Despite the substantial self-care requirements, there are no empirically based interventions to enhance the skills and confidence of these survivors in managing their ongoing care.ObjectiveThe aim of this study is to describe the rationale and methodology for a randomized controlled trial evaluating Empowered Survivor (ES) versus Springboard Beyond Cancer, a general web-based program for cancer survivors, on self-efficacy in managing care, preparedness for managing survivorship, and health-related quality of life (QOL).MethodsThis study will recruit a total of 600 individuals who were diagnosed with oral cavity or oropharyngeal cancer in the past 3 years and are currently cancer free primarily from state cancer registries; these individuals will be randomly assigned to either the ES or Springboard Beyond Cancer condition. The participants complete measures of self-efficacy in managing care, preparedness for survivorship, health-related QOL, and engagement in oral self-examination and head and neck strengthening and flexibility exercises at baseline and 2 and 6 months after baseline. The primary aim of this study is to evaluate the impact of ES versus Springboard Beyond Cancer on self-efficacy, preparedness, and health-related QOL. The secondary aim is to examine the mediators and moderators of ES's impact on self-efficacy in managing care, preparedness, and health-related QOL at 6 months. The exploratory aim is to conduct a process evaluation of ES to identify potential oncology or community settings for future implementation.ResultsMultilevel modeling will be used to examine whether there are significant differences between the ES and Springboard Beyond Cancer interventions over time. Mediational models will evaluate the indirect effects of ES on outcomes. Quantitative analyses will evaluate the predictors of ES use, and qualitative analyses will evaluate the preferred timing and settings for the implementation of ES.ConclusionsThis randomized controlled trial evaluates a completely web-based intervention, ES, versus a general web-based program for cancer survivors, Springboard Beyond Cancer, on self-efficacy in managing care, preparedness for managing survivorship, and health-related QOL and identifies the putative mediators and moderators of the intervention's effects. If an effect on the primary outcomes is illustrated, the next step could be an implementation trial to evaluate the intervention's uptake in and impact on an oncology care setting or nonprofit organizations.Trial registrationClincalTrials.gov NCT04713449; https://clinicaltrials.gov/ct2/show/NCT04713449.International registered report identifier (irrid)DERR1-10.2196/39996.
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Project description:This pilot study evaluated the feasibility, acceptability, and potential efficacy of a 4-week hypnosis audio-recording intervention in cancer survivors with chronic pain. Forty participants were randomly assigned to treatment (n = 21) or wait-list (n = 19) conditions. Pain intensity ratings were lower at Week 4 for both groups. The effect size for pain reduction in the treatment group was d = 0.25 from baseline to 4 weeks, and the interaction effect (Time x Group) was F = .024; η2p = .001. The small interaction effect may be due to the availability of only one recording and large variability in dose. Qualitative data indicated that the intervention's benefits included participation in self-care, improved relaxation, and an opportunity to focus on oneself in a positive way. Further efficacy testing of an audio-recording intervention in a fully powered clinical trial is warranted.
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Project description:ObjectiveApply the National Institutes of Health (NIH) Stage Model to design and test an intervention to prevent depression in breast cancer patients at risk for depression.MethodsWe identified mindful emotion awareness, along with approach and avoidance strategies for cancer-related coping and emotion regulation, as targets for a preventive intervention adapted from the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Patients' preferences for individual, in-person, and time-efficient sessions informed the design. Patients at risk for depression received a 6-week, 5-hour intervention with daily exercises. Intervention targets were assessed at baseline, before each session, and 4-weeks post intervention. Mixed effects analysis of variance (ANOVA) assessed change over the follow-up period, controlling for age, partnered status, and disease stage.ResultsFifty-five percent (40/72) of women screened within 6 months of diagnosis had elevated depression risk. Of these, 24 (60%) signed consent. Sixteen received intervention after five were excluded for current depressive disorder, cognitive impairment, or death. Three dropped out. Ninety-eight percent attendance and 77% practice days indicated feasibility. Effect sizes (Cohen's d) corrected for regression to the mean (RTM) were 0.82 for cancer-related acceptance coping, 0.65 for cancer-related emotional expression, and 0.32 and 0.42 for decreased cancer-related avoidance coping and depressive symptoms, respectively. Effect sizes for variables lacking data to correct for RTM were 1.0, 0.7, and 0.5 for decreased rumination, experiential avoidance, and fear of depression, respectively, and 1.3, 0.6, and 0.4 for increased cognitive flexibility, distress tolerance, and describing/not judging emotions, respectively.ConclusionsThe feasibility of this intervention and malleability of its targets support its further investigation.
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Project description:BackgroundAs of 2016, almost 16 million individuals were cancer survivors, including over 3.5 million survivors of breast cancer. Because cancer survivors are living longer and have unique health care needs, the Institute of Medicine proposed a survivor care plan as a way to alleviate the many medical, emotional, and care coordination problems of survivors.ObjectiveThis pilot study for breast cancer survivors was undertaken to: (1) examine self-reported changes in knowledge, confidence, and activation from before receipt to after receipt of a survivor care plan; and (2) describe survivor preferences for, and satisfaction with, a technology-based survivor care plan.MethodsA single group pretest-posttest design was used to study breast cancer survivors in an academic cancer center and a community cancer center during their medical visit after they completed chemotherapy. The intervention was a technology-based survivor care plan. Measures were taken before, immediately after, and 1 month after receipt of the survivor care plan.ResultsA total of 38 breast cancer survivors agreed to participate in the study. Compared to baseline levels before receipt of the survivor care plan, participants reported increased knowledge both immediately after its receipt at the academic center (P<.001) and the community center (P<.001) as well as one month later at the academic center (P=.002) and the community center (P<.001). Participants also reported increased confidence immediately following receipt of the survivor care plan at the academic center (P=.63) and the community center (P=.003) and one month later at both the academic center (P=.63) and the community center (P<.001). Activation was increased from baseline to post-survivor care plan at both the academic center (P=.05) and community center (P<.001) as well as from baseline to 1-month follow-up at the academic center (P=.56) and the community center (P<.001). Overall, community center participants had lower knowledge, confidence, and activation at baseline compared with academic center participants. Overall, 22/38 (58%) participants chose the fully functional electronic survivor care plan. However, 12/23 (52%) in the community center group chose the paper version compared to 4/15 (27%) in the academic center group. Satisfaction with the format (38/38 participants) and the content (37/38 participants) of the survivor care plan was high for both groups.ConclusionsThis study provides evidence that knowledge, confidence, and activation of survivors were associated with implementation of the survivor care plan. This research agrees with previous research showing that cancer survivors found the technology-based survivor care plan to be acceptable. More research is needed to determine the optimal approach to survivor care planning to ensure that all cancer survivors can benefit from it.
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Project description:PurposeChildhood cancer survivors are at increased risk for underinsurance and health insurance-related financial burden. Interventions targeting health insurance literacy (HIL) to improve the ability to understand and use health insurance are needed.MethodsWe codeveloped a four-session health insurance navigation tools (HINT) intervention, delivered synchronously by a patient navigator, and a corresponding booklet. We conducted a randomized pilot trial with survivors from the Childhood Cancer Survivor Study comparing HINT with enhanced usual care (EUC; booklet). We assessed feasibility, acceptability, and preliminary efficacy (HIL, primary outcome; knowledge and confidence with health insurance terms and activity) on a 5-month survey and exit interviews.ResultsAmong 231 invited, 82 (32.5%) survivors enrolled (53.7% female; median age 39 years, 75.6% had employer-sponsored insurance). Baseline HIL scores were low (mean = 28.5; 16-64; lower scores better); many lacked knowledge of Affordable Care Act (ACA) provisions. 80.5% completed four HINT sessions, and 93.9% completed the follow-up survey. Participants rated HINT's helpfulness a mean of 8.9 (0-10). Exit interviews confirmed HINT's acceptability, specifically its virtual and personalized delivery and helpfulness in building confidence in understanding one's coverage. Compared with EUC, HINT significantly improved HIL (effect size = 0.94. P < .001), ACA provisions knowledge (effect size = 0.73, P = .003), psychological financial hardship (effect size = 0.64, P < .006), and health insurance satisfaction (effect size = 0.55, P = .03).ConclusionResults support the feasibility and acceptability of a virtual health insurance navigation program targeted for childhood survivors to improve HIL. Randomized trials to assess the efficacy and sustainability of health insurance navigation on HIL and financial burden are needed.
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Project description:BackgroundAdvanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. This single-arm preliminary pilot study aims to explore the effects of a six-month early intervention program following reconstructive surgery in oral cancer survivors.MethodsA total of 65 participants were analyzed following reconstructive surgery. Outcome measurements were taken during the first visit, and at one, three and six months after reconstructive surgery.ResultsScapular muscle strength and shoulder range of motion progressively improved during the 6-month follow-up. The mean Disability of the Arms, Shoulder and Hand (DASH) score showed significant improvement at 1 month (p < .001). Health related QoL showed significant differences between baseline and 6-months post-surgery scores on global health and on most of the function and symptom scales. The predicted return-to-work rate was 80% at one year after the operation. Return-to-work rate differs in different vocational types, with a higher rate of return in the skilled or semi-skilled (87.5%) and self-employed (86.7%).ConclusionsWe suggest that early integrated intervention program with a follow-up of at least six months following reconstructive surgery may help develop and identify intervention guidelines and goals in the initial six months of treatment following neck dissection in oral cancer survivors.
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Project description:BackgroundHealth behavior and weight management interventions for cancer survivors have the potential to prevent future cancer recurrence and improve long-term health; however, their translation can be limited if the intervention is complex and involves high participant burden. Mobile health (mHealth) offers a delivery modality to integrate interventions into daily life routines.ObjectiveThe objective of this study was to evaluate the effects of a one-group trial with a pre-post evaluation design on engagement (use and acceptability), physiological (weight), behavioral (diet and physical activity), and other secondary outcomes.MethodsThe 10-week intervention consisted of mHealth components (self-monitoring of selected diet behaviors via daily text messages, wireless devices to automatically track weight and steps) and 4 motivational interviewing-based technology-assisted phone sessions with a nonprofessionally trained counselor. Participants were overweight breast cancer survivors who had completed treatment and owned a smartphone. Weight was measured objectively; diet and physical activity were measured with brief self-reported questionnaires.ResultsTen women participated; they had a mean age of 59 years (SD 6), 50% belonged to a racial or ethnic minority group, 50% had some college or less, and 40% reported using Medicaid health insurance. Engagement was high: out of 70 days in total, the mean number of days recording steps via the wristband pedometer was 64 (SD 7), recording a weight via the scale was 45 (SD 24), and responding to text messages was 60 (SD 13); 100% of participants completed all 4 calls with the counselor. Most (90%) were very likely to participate again and recommend the program to others. Mean weight in pounds decreased (182.5 to 179.1, mean change -3.38 [SD 7.67]), fruit and vegetable daily servings increased (2.89 to 4.42, mean change 1.53 [SD 2.82]), and self-reported moderate physical activity increased in metabolic equivalent of task (MET) minutes per week (2791 to 3336, mean change 545 [SD 1694]).ConclusionsFindings support the conduct of a fully powered trial to evaluate the efficacy of mHealth as a feasible intervention modality for breast cancer survivors. Future research should employ accelerometer-based physical activity assessment and consider development of an all-in-one app to integrate devices, messaging, and educational content and other mHealth approaches to support behavioral counselors conducting weight management interventions.Trial registrationClinicalTrials.gov NCT02387671; https://clinicaltrials.gov/ct2/show/NCT02387671 (Archived by WebCite at http://www.webcitation.org/6hGEuttbZ).
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