Dataset Information

Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial.

ABSTRACT:

Purpose

Determine the feasibility of a remotely delivered mobile health (mHealth)-supported intervention to improve diet and physical activity in hematologic malignancy survivors.

Methods

Pilot randomized controlled trial of a 16-week intervention for improving diet and physical activity: individualized goal-setting (daily steps, sodium, saturated fat, added sugar intake) per feedback from mHealth trackers (Fitbit for activity; Healthwatch360 for diet), supplemented by a Facebook peer support group. Controls accessed the trackers without goal-setting or peer support. Everyone received standardized survivorship counseling with tailored advice from a clinician. Actigraphy and food frequency questionnaires assessed activity and diet at baseline and follow-up.

Results

Forty-one participants (51.2% male; median age 45.1 years; 7.0 years from treatment) were randomized (24 intervention; 17 control). Fitbit and Healthwatch360 use were more common among intervention versus control participants (75.0% versus 70.6% and 50.0% versus 17.7% of eligible days, respectively). Most intervention participants (66.7%) engaged with Facebook; overall, 91.7% interacted with the study's mHealth applications. While no comparisons in activity or dietary outcomes between intervention versus control group met statistical significance, the intervention was associated with greater reductions in the targeted dietary factors and improvements in Healthy Eating Index-2015 score, moderate-vigorous physical activity time, and daily steps. Participant retention at 6 months was 90.2%.

Conclusions

An intervention for cardiovascular risk reduction based on individualized goal-setting enhanced by mHealth and social media peer support was feasible and acceptable among cancer survivors.

Implications for cancer survivors

Effective and easily disseminated strategies that improve diet and physical activity in this population are needed.

Trial registration

Registered in ClinicalTrials.gov (NCT03574012) on June 29, 2018.

SUBMITTER: Chow EJ

PROVIDER: S-EPMC8035343 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Publications

Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial.

Chow Eric J EJ Doody David R DR Di Chongzhi C Armenian Saro H SH Baker K Scott KS Bricker Jonathan B JB Gopal Ajay K AK Hagen Anna M AM Ketterl Tyler G TG Lee Stephanie J SJ Reding Kerryn W KW Schenk Jeannette M JM Syrjala Karen L KL Taylor Sarah A SA Wang Guangxing G Neuhouser Marian L ML Mendoza Jason A JA

Journal of cancer survivorship : research and practice 20201010 4

<h4>Purpose</h4>Determine the feasibility of a remotely delivered mobile health (mHealth)-supported intervention to improve diet and physical activity in hematologic malignancy survivors.<h4>Methods</h4>Pilot randomized controlled trial of a 16-week intervention for improving diet and physical activity: individualized goal-setting (daily steps, sodium, saturated fat, added sugar intake) per feedback from mHealth trackers (Fitbit for activity; Healthwatch360 for diet), supplemented by a Facebook ...[more]

PMID: 33037989

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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).

Project description:BackgroundSedentary behavior among breast cancer survivors is associated with increased risk of poor physical function and worse quality of life. While moderate to vigorous physical activity can improve outcomes for cancer survivors, many are unable to engage in that intensity of physical activity. Decreasing sitting time may be a more feasible behavioral target to potentially mitigate the impact of cancer and its treatments.ObjectiveThe purpose of this study was to investigate the feasibility and preliminary impact of an intervention to reduce sitting time on changes to physical function and quality of life in breast cancer survivors, from baseline to a 3-month follow-up.MethodsFemale breast cancer survivors with self-reported difficulties with physical function received one-on-one, in-person personalized health coaching sessions aimed at reducing sitting time. At baseline and follow-up, participants wore the activPAL (thigh-worn accelerometer; PAL Technologies) for 3 months and completed physical function tests (4-Meter Walk Test, Timed Up and Go, and 30-Second Chair Stand) and Patient-Reported Outcomes Measurement Information System (PROMIS) self-reported outcomes. Changes in physical function and sedentary behavior outcomes were assessed by linear mixed models.ResultsOn average, participants (n=20) were aged 64.5 (SD 9.4) years; had a BMI of 30.4 (SD 4.5) kg/m2; and identified as Black or African American (n=3, 15%), Hispanic or Latina (n=4, 20%), and non-Hispanic White (n=14, 55%). Average time since diagnosis was 5.8 (SD 2.2) years with participants receiving chemotherapy (n=8, 40%), radiotherapy (n=18, 90%), or endocrine therapy (n=17, 85%). The intervention led to significant reductions in sitting time: activPAL average daily sitting time decreased from 645.7 (SD 72.4) to 532.7 (SD 142.1; β=-112.9; P=.001) minutes and average daily long sitting bouts (bout length ≥20 min) decreased from 468.3 (SD 94.9) to 366.9 (SD 150.4; β=-101.4; P=.002) minutes. All physical function tests had significant improvements: on average, 4-Meter Walk Test performance decreased from 4.23 (SD 0.95) to 3.61 (SD 2.53; β=-.63; P=.002) seconds, Timed Up and Go performance decreased from 10.30 (SD 3.32) to 8.84 (SD 1.58; β=-1.46; P=.003) seconds, and 30-Second Chair Stand performance increased from 9.75 (SD 2.81) to 13.20 completions (SD 2.53; β=3.45; P<.001). PROMIS self-reported physical function score improved from 44.59 (SD 4.40) to 47.12 (SD 5.68; β=2.53; P=.05) and average fatigue decreased from 52.51 (SD 10.38) to 47.73 (SD 8.43; β=-4.78; P=.02).ConclusionsThis 3-month pilot study suggests that decreasing time spent sitting may be helpful for breast cancer survivors experiencing difficulties with physical function and fatigue. Reducing sitting time is a novel and potentially more feasible approach to improving health and quality of life in cancer survivors.

Project description:BackgroundIn the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences.MethodsTo develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of a well-known PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences.ResultsA total of 496 authors were invited to take part in the three-round Delphi survey (round 1, N = 46; round 2, N = 24; round 3, N = 22). A set of twenty considerations, broadly categorized into six themes (intervention design, study design, conduct of trial, implementation of intervention, statistical analysis, and reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading.ConclusionWe leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.

Project description:BACKGROUND:Psychological distress is a major issue among survivors of women's cancer who face numerous barriers to accessing in-person mental health treatments. Mobile phone app-based interventions are scalable and have the potential to increase access to mental health care among survivors of women's cancer worldwide. OBJECTIVE:This study aimed to evaluate the acceptability and preliminary efficacy of a novel app-based intervention with phone coaching in a sample of survivors of women's cancer. METHODS:In a single-group, pre-post, 6-week pilot study in the United States, 28 survivors of women's cancer used iCanThrive, a novel app intervention that teaches skills for coping with stress and enhancing well-being, with added phone coaching. The primary outcome was self-reported symptoms of depression (Center for Epidemiologic Studies Depression Scale). Emotional self-efficacy and sleep disruption were also assessed at baseline, 6-week postintervention, and 4 weeks after the intervention period. Feedback obtained at the end of the study focused on user experience of the intervention. RESULTS:There were significant decreases in symptoms of depression and sleep disruption from baseline to postintervention. Sleep disruption remained significantly lower at 4-week postintervention compared with baseline. The iCanThrive app was launched a median of 20.5 times over the intervention period. The median length of use was 2.1 min. Of the individuals who initiated the intervention, 87% (20/23) completed the 6-week intervention. CONCLUSIONS:This pilot study provides support for the acceptability and preliminary efficacy of the iCanThrive intervention. Future work should validate the intervention in a larger randomized controlled study. It is important to develop scalable interventions that meet the psychosocial needs of different cancer populations. The modular structure of the iCanThrive app and phone coaching could impact a large population of survivors of women's cancer.

Project description:BackgroundMental illness is one of the top causes of preventable pregnancy-related deaths in the United States. There are many barriers that interfere with the ability of perinatal individuals to access traditional mental health care. Digital health interventions, including app-based programs, have the potential to increase access to useful tools for these individuals. Although numerous mental health apps exist, there is little research on developing programs to address the unique needs of perinatal individuals. In an effort to fill this gap, a multidisciplinary team of experts in psychology, psychiatry, obstetrics, and pediatric primary care collaborated to develop the novel Perinatal Skills Program within Maya, a flexible and customizable cognitive-behavioral skills app. Maya-Perinatal Skills Program (M-PSP) uses evidence-based strategies to help individuals manage their mood and anxiety symptoms during pregnancy and post partum.ObjectiveThis pilot study aims to assess the feasibility, acceptability, and usability of M-PSP and explore links between program use and symptoms of anxiety and low mood.MethodsThis single-arm trial will recruit 50 pregnant or postpartum individuals with mild-to-moderate anxiety or mood symptoms. Participants will be recruited from a variety of public and private insurance-based psychiatry, obstetrics, and primary care clinics at a large academic medical center located in New York City. Participants will complete all sessions of M-PSP and provide feedback. Outcome measures will include qualitative and quantitative assessments of feasibility, acceptability, and usability, passively collected program usage data, and symptom measures assessing mood, anxiety, and trauma. Planned data analysis includes the use of the grounded theory approach to identify common themes in qualitative feedback, as well as an exploration of possible associations between quantitative data regarding program use and symptoms.ResultsThe recruitment began on August 2023. As of October 2024, a total of 32 participants have been enrolled. The recruitment will continue until 50 participants have been enrolled.ConclusionsDigital health interventions, like M-PSP, have the potential to create new pathways to reach individuals struggling with their mental health. The results of this study will be the groundwork for future iterations of M-PSP in the hopes of providing an accessible and helpful tool for pregnant and postpartum individuals.Trial registrationClinicalTrials.gov NCT05897619; https://classic.clinicaltrials.gov/ct2/show/NCT05897619.International registered report identifier (irrid)PRR1-10.2196/59461.

Project description:BackgroundYouth homelessness is a substantial issue, and many youths experiencing homelessness have mental health issues as both a cause and consequence of homelessness. These youths face many barriers to receiving traditional mental health services, and as a result, only a few youths experiencing homelessness receive any form of mental health care.ObjectiveThis project aimed to develop and determine the feasibility and acceptability of engaging young adults (ie, individuals aged 18-24 years) experiencing homelessness in a remotely delivered mental health intervention. This intervention provided brief emotional support and coping skills, drawing from cognitive behavioral principles as an introduction into psychosocial support. The intervention was piloted in a homeless shelter network.MethodsA total of 35 young adults experiencing homelessness participated in a single-arm feasibility pilot trial. Participants received a mobile phone, a service and data plan, and 1 month of support from a coach consisting of up to 3 brief phone sessions, text messaging, and mobile mental health apps. We evaluated feasibility by looking at completion of sessions as well as the overall program and acceptability with satisfaction ratings. We also collected clinical symptoms at baseline and the end of the 1-month support period. We used validity items to identify participants who might be responding inappropriately and thus only report satisfaction ratings and clinical outcomes from valid responses.ResultsMost participants (20/35, 57%) completed all 3 of their phone sessions, with an average of 2.09 sessions (SD 1.22) completed by each participant. Participants sent an average of 15.06 text messages (SD 12.62) and received an average of 19.34 messages (SD 12.70). We found higher rates of satisfaction among the participants with valid responses, with 100% (23/23) of such participants indicating that they would recommend participation to someone else and 52% (12/23) reporting that they were very or extremely satisfied with their participation. We found very little change from pre- to posttreatment on measures of depression (d=0.27), post-traumatic stress disorder (d=0.17), and emotion regulation (d=0.10).ConclusionsThis study demonstrated that it was feasible to engage homeless young adults in mental health services in this technology-based intervention with high rates of satisfaction. We did not find changes in clinical outcomes; however, we had a small sample size and a brief intervention. Technology might be an important avenue to reach young adults experiencing homelessness, but additional work could explore proper interventions to deliver with such a platform.Trial registrationClinicalTrials.gov NCT03620682; https://clinicaltrials.gov/ct2/show/NCT03620682.

Dataset Information

Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial.

Purpose

Methods

Results

Conclusions

Implications for cancer survivors

Trial registration

Publications

Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial.

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