CancerNCT05459168
Development of Calm for Cancer Prototype Mobile App
A study testing Calm Meditation Smartphone App Feedback, Cancer-Specific Meditation App Prototype Design and Cancer-Specific Meditation App Prototype in people with Cancer, run by Calm.com, Inc. at 1 site in United States.
Trial summary
Using the IDEAS (Integrate, Design, Assess, and Share) framework, the investigators will conduct the following aims: Specific Aim 1: Using two focus groups, the investigators will INTEGRATE formative work, the social cognitive theory, and perspectives from the experienced-user advisory committee (N=20) who will use… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Calm Meditation Smartphone App Feedback, Cancer-Specific Meditation App Prototype Design and Cancer-Specific Meditation App Prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Interested cancer patients/survivors (Aim 3) will be asked to complete an eligibility survey via a REDCap survey link. Eligibility criteria is as follows:
Patients/survivors will be eligible if they are:
- at least 18 years of age
- able to read and understand English
- identify as a cancer patient (i.e., currently receiving treatment) or a survivor (i.e., prior patient no longer receiving treatment)
- willing to download the cancer-specific app prototype to their phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leveraging an Academic-Industry Partnership to Develop a Cancer-Specific Mobile Meditation App
Using the IDEAS (Integrate, Design, Assess, and Share) framework, the investigators will conduct the following aims:
Specific Aim 1: Using two focus groups, the investigators will INTEGRATE formative work, the social cognitive theory, and perspectives from the experienced-user advisory committee (N=20) who will use the current Calm platform to identify design content and features for a standalone cancer-specific app prototype leveraging the commercial infrastructure of the Calm platform. The advisory committee will consist of both cancer patients/survivors (n=10; 5 of each) and health care providers (n=10).
Read more
Specific Aim 2: DESIGN a meditation app prototype tailored to cancer patients/survivors unique needs including content related to cancer-related experiences, emotions, symptoms, physical and psychological needs, cancer-specific symptom self monitoring, social support and sense of belonging within the app and through Facebook.
Specific Aim 3: ASSESS (i.e., beta-test) the prototype's form and function with cancer patients/survivors (N=30). The investigators will use Bowen's feasibility model to determine via surveys and interviews: (a) acceptability (satisfaction, perceived appropriateness, perceived positive/negative effects); (b) demand (use of the app, interest or intention to use); (c) practicality (how it makes them feel, ease of use); (d) adaptation (suggestions for modifications to improve performance for cancer patients/survivors); and (e) integration (how can the app be integrated into the cancer "system") Feasibility benchmarks: >80% of cancer patients/survivors will accept the prototype, demand the prototype for themselves and other cancer patients/survivors, and find it practical. Data from Aim 3 will guide refinement of the prototype to be tested in a fully powered RCT to establish long term engagement (Phase 2). This work will result in an evidence based, cancer-specific meditation app through a commercial platform that can be scaled and sold at discounted costs to clinic providers and directly to patients (SHARE; Phase 3).
Read the detailed description
This STTR consists of three aims, each of which are conducted in successive order, with the end result being a cancer-specific meditation app prototype ready for efficacy testing (Phase 2) and direct marketing to the consumer (Phase 3).
Aim 1: Using the IDEAS framework, the investigators will INTEGRATE a) perspectives from an informed advisory committee (N=20) about the current Calm platform and b) strategies from the social cognitive theory to design a cancer-specific meditation app prototype. The meaning of the IDEAS stage INTEGRATE is to uncover deeper needs, values, and motivations, engaging key stakeholders (i.e., patients and providers) and use behavioral theory to inspire solutions that are more relevant and acceptable to the target population. Procedures: The advisory committee will consist of informed cancer patients, survivors (n=10; 5 of each) and healthcare providers (n=10; physicians, oncology nurses, cancer care coordinators, directors of integrative programs in cancer centers, and not-for-profit partners; See Support Letters). The advisory committee members are drawn from partnerships with Mays Cancer Center at UT Health San Antonio, MD Anderson, the Mayo Clinic in Scottsdale, AZ and Rochester, NY, University of Arizona, Wake Forest, Leukemia and Lymphoma Society, and the American Cancer Society. Both patients/survivors and providers are included on the advisory committee because providers play a key role in recommending mobile tools to patients to self-manage their symptoms, providers are often uninvolved stakeholders related to app design, and integrating apps into scalable interventions requires support of both patients/survivors and providers. The selection criteria prioritizes the cancer patient and survivor experience, but also includes members who see and hear the preferences, points of reluctance, stated and unstated barriers, and behavioral choices of those they serve in a variety of capacities (medical, ancillary, and direct provision of in-person meditation options).
The advisory committee will be asked to: (1) use the Calm app for at least 10 minutes a day for seven days to explore its content and features, (2) keep an informal journal of (a) time of day and time spent using Calm, (b) responses to app options and what motivated them to make certain choices, (c) their experiences during the guided meditations, and (d) ideas about life experiences of a cancer patient to include in prototype, (e) responses to prompts related to strategies from SCT, (e.g., in what ways might the content or features of the app support a sense of social modeling from other cancer patients or providers? How might goal setting and rewards be incorporated appropriately?) and (f) if not a cancer patient or survivor, to reflect upon the perspective of those they treat or serve, and (3) participate in a virtual focus group to provide informed, meaningful and specific input for the prototype. Focus groups have a long history in industry and marketing when the goal is to evaluate responses to products or ideas under development. Considering Coronavirus 2019, virtual focus groups will be conducted based on best-practice guidelines for internet-based qualitative research. One developer from Calm will listen to the focus groups for practical guidance and to meet target needs in the prototype design (Aim 2). The investigators will use Bowen's feasibility framework to explore specific domains of design (acceptability, demand, practicality, adaptation, and integration) (examples are open-ended experiential and cancer-referenced content explorations). The investigators believe this informed-user stage will strengthen the advisory committees' ability to direct the following design and assessment stages where they will be advisors not users. These informed-user focus groups will direct the DESIGN stage in Aim 2, by developing a list of the content and features, prioritized by numbers of mentions and importance emphasized. Milestone for Aim 1: Prioritize a list of 10-12 key content and feature issues to use in designing the prototype and promoting continued engagement.
Aim 2: Using the IDEAS framework, the investigators will DESIGN a cancer-specific meditation app prototype. IDEAS framework suggests prototyping leads to objectively stronger final products. The process includes understanding the most frequent requests, deciding on goals and non-goals, and writing out how users should interact with specific features. The investigators will use findings from Aim 1 to rapidly develop server-side Application Programming Interface (APIs) and an app for iOS. Themes and feedback from the feasibility focus groups (e.g., how to cultivate acceptance, demand, practicality, etc.) will be used to extend the current Calm design, APIs, and app so that the content, layout, and features in the app will address specific cancer-related long-term needs.
Design: The first step is to mock up user experience, user interface flows, and screens in the mobile app that fit with the values and user requirements from the focus groups. The investigators will mock and create wireframes of potential flow and solutions. The designs will be iterated based on feedback. Once the investigators have clear wireframes and specifications, they will create high-fidelity build mock ups.
API and mobile application development: The investigators will build out an interactive prototype by extending Calm's API. The API is a web interface that will help facilitate communication between the mobile application (front-end) and the software running on the server (back-end). It will allow the app to extend its functionalities by making use of other software subroutines running remotely on a server. The APIs will be REST-based and developed in JavaScript using a web framework known as Node.js with a Postgres database. The current Calm system is deployed using Kubernetes, provisioned with Terraform and hosted on Amazon Web Services. All API communication between the servers and clients is done through HTTPS (Hypertext Transfer Protocol Secure) for secure communication. The servers will handle the logic of what, where, when, and how information should be displayed. This will allow the front-end team to move more quickly, focus on user experience, user interface and beautiful animations rather than duplicating the complex business logic. The investigators can move very quickly to automatically change the way content is displayed on the server without user app updates. The API handles authentication, identity management, content, session history, subscriptions, AB test enrollment, assets, surveys and polls, onboarding flows, and scenes. The investigators also have admin endpoints that are deployed inside the virtual private cloud and are not publicly accessible. These routes power the internal tools, which support scene and program uploading, user management, admin activity logs and notes, and debugging. Thus, all aspects of the existing Calm app, from meditation tracks and content to the specific visual and selection paths, even to the inner structural workings of the app can be adapted with recommendations from Aim 1. After specifying the API changes, the investigators will change the API code and front-end app to speak to the API. This results in the prototype app specifically targeting cancer patients and survivors to be used in Aim 3. All data will be encrypted and the patient will use a password to access the app. Security and compliance standards will meet the requirements as a business associate of a healthcare provider, including HIPAA policies and procedures.
Aim 3: Using the IDEAS framework, the investigators will ASSESS (i.e., beta-test) the feasibility of the cancer-specific meditation app prototype with a sample of cancer patients/survivors (N=30). The investigators will recruit cancer patients/survivors with varying cancer types and stages, race/ethnicity, rural/urban geographic settings, and genders via social media. The investigators have 100 letters of support from cancer patients/survivors supporting the development of a cancer-specific Calm app. Studies suggest 5-10 participants are sufficient to establish feasibility and detect technical difficulties. The sample size is not to establish efficacy, but the multiple components of feasibility. The investigators have included a larger number to ensure a variety of cancer-related experiences. Beta-test participants will be asked to use the prototype for four weeks (free access) for at least 10 minutes per day, but will be encouraged to use it as much as they would like, mimicking how a new paying member would use the existing Calm app. Participation (meditations completed, time of day, length of time, components used) will be tracked (provided by Calm) over the four weeks. The 4-week period is not to establish efficacy but is an appropriate time to test feasibility. To determine acceptability, demand, and practicality, participants will be asked to complete weekly satisfaction questionnaires in addition to a final overall study satisfaction questionnaire immediately post-intervention using REDCap. Following the 4-week beta-test, and in addition to a satisfaction questionnaire the investigators will ask participants to volunteer for a semi-structured interview to determine, using Bowen's feasibility model, acceptability, demand, practicality, adaptation and integration to optimize potential for uptake, engagement and continued use at recommended levels (i.e., at least 10 min/day). Themes and findings from the interviews will be shared with the advisory committee and used to translate findings into app-relevant recommendations (i.e., further revisions if necessary) for efficacy testing (Phase 2). This approach is similar to methods used in other studies designing and developing mobile apps. Due to COVID-19, the investigators will conduct interviews virtually, based on best-practice guidelines for internet-based qualitative research.
- Conditions
- Cancer
- Being tested
- Calm Meditation Smartphone App Feedback, Cancer-Specific Meditation App Prototype Design, Cancer-Specific Meditation App Prototype
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm Meditation Smartphone App FeedbackOther
Advisory committee members will be asked to use the current Calm meditation app platform for a full week and to keep an informal journal prior to participating in focus groups in which they will provide feedback about the app.
Cancer-Specific Meditation App Prototype DesignOther
Findings from Aim 1 will inform the development of a cancer-specific meditation app prototype to be tested in Aim 3.
Cancer-Specific Meditation App PrototypeDevice
Recruited cancer patients/survivors will be asked to beta-test the cancer-specific app prototype for four weeks. The prototype will be developed in Aim 2 and informed by qualitative findings of Aim 1.
| Study group | Role | What they receive |
|---|---|---|
| Calm Meditation Smartphone App Feedback (Aim 1) | Other | Advisory committee members will be asked to use the current Calm meditation app platform for a full week and to keep an informal journal prior to participating in focus groups in which they will provide feedback about the app. Receives: Other: Calm Meditation Smartphone App Feedback |
| Cancer-Specific Meditation App Prototype Design (Aim 2) | Other | Findings from Aim 1 will inform the development of a cancer-specific meditation app prototype to be tested in Aim 3. Receives: Other: Cancer-Specific Meditation App Prototype Design |
| Cancer-Specific Meditation App Prototype (Aim 3) | Other | Recruited cancer patients/survivors will be asked to beta-test the cancer-specific app prototype for four weeks. The prototype will be developed in Aim 2 and informed by qualitative findings of Aim 1. Receives: Device: Cancer-Specific Meditation App Prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Feasibility: Acceptability as assessed with focus groups
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Measured: Questions asked at one week of use of the current Calm platform
Feasibility: Demand as assessed with focus groups
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Measured: Questions asked at one week of use of the current Calm platform
Aim 1: Feasibility: Practicality as assessed with focus groups
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Measured: Questions asked at one week of use of the current Calm platform
Aim 1: Feasibility: Adaptation as assessed with focus groups
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Measured: Questions asked at one week of use of the current Calm platform
Aim 1: Feasibility: Integration as assessed with focus groups
Integration is defined as Integration degree of execution, amount and type of resources needed to implement, factors affecting ease of implementation according to Bowen and colleagues feasibility criteria.
Measured: Questions asked at one week of use of the current Calm platform
Aim 3: Feasibility: Acceptability as assessed with survey
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 1
Aim 3: Feasibility: Acceptability as assessed with survey
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 2
Aim 3: Feasibility: Acceptability as assessed with survey
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 3
Aim 3: Feasibility: Acceptability as assessed with survey
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 4
Aim 3: Feasibility: Acceptability as assessed with survey
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a post-intervention (week 4) satisfaction survey
Aim 3: Feasibility: Acceptability as assessed with interview
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a post-intervention (week 4) structured interview
Aim 3: Feasibility: Demand as assessed with survey
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 1
Aim 3: Feasibility: Demand as assessed with survey
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 2
Aim 3: Feasibility: Demand as assessed with survey
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 3
Aim 3: Feasibility: Demand as assessed with survey
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 4
Aim 3: Feasibility: Demand as assessed with survey
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a post-intervention (week 4) survey
Aim 3: Feasibility: Demand as assessed with interview
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a post-intervention (week 4) structured interview
Aim 3: Feasibility: Demand captured via Calm-provided data
Calm will track weekly minutes of meditation participation for each participant.
Measured: Calm-provided data capturing meditation participation at post-intervention (week 4)
Aim 3: Feasibility: Practicality as assessed with survey
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 1
Aim 3: Feasibility: Practicality as assessed with survey
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 2
Aim 3: Feasibility: Practicality as assessed with survey
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 3
Aim 3: Feasibility: Practicality as assessed with survey
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 4
Aim 3: Feasibility: Practicality as assessed with survey
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a post-intervention (week 4) survey
Aim 3: Feasibility: Practicality as assessed with interview
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a post-intervention (week 4) structured interview
Aim 3: Feasibility: Adaptation as assessed with survey
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a weekly satisfaction survey (week 1 to week 4)
Aim 3: Feasibility: Adaptation as assessed with survey
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 1
Aim 3: Feasibility: Adaptation as assessed with survey
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 2
Aim 3: Feasibility: Adaptation as assessed with survey
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 3
Aim 3: Feasibility: Adaptation as assessed with survey
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a satisfaction survey after week 4
Aim 3: Feasibility: Adaptation as assessed with interview
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a post-intervention (week 4) structured interview
Aim 3: Feasibility: Integration as assessed with survey
Integration is defined as Integration degree of execution, amount and type of resources needed to implement, factors affecting ease of implementation according to Bowen and colleagues feasibility criteria.
Measured: Questions will be asked with a post-intervention (week 4) survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Mar 2021
- Primary completion28 Feb 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This study consists of multiple phases/aims, but within each phase/aim (excluding Aim 2 as this is just app development), there is a single group assignment. The intervention model layout described herein was the most appropriate method to describe each of the involved phases and steps.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calm.com, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459168
- Sponsor's protocol ID
- STUDY00013029
- Status last verified
- May 2022
- First submitted
- 17 Mar 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huberty J, Bhuiyan N, Puzia M, Joeman L, Larkey L, Mesa R. Meditation Mobile App Developed for Patients With and Survivors of Cancer: Feasibility Randomized Controlled Trial. JMIR Cancer. 2022 Nov 23;8(4):e39228. doi: 10.2196/39228.
PubMed 36416880
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging an Academic-Industry Partnership to Develop a Cancer-Specific Mobile Meditation App
- ClinicalTrials.gov ID
- NCT05459168
- Acronym / sponsor ID
- STUDY00013029
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Calm.com, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center at San Antonio, Arizona State University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using the IDEAS (Integrate, Design, Assess, and Share) framework, the investigators will conduct the following aims:
Specific Aim 1: Using two focus groups, the investigators will INTEGRATE formative work, the social cognitive theory, and perspectives from the experienced-user advisory committee (N=20) who will use the current Calm platform to identify design content and features for a standalone cancer-specific app prototype leveraging the commercial infrastructure of the Calm platform. The advisory committee will consist of both cancer patients/survivors (n=10; 5 of each) and health care providers (n=10).
Specific Aim 2: DESIGN a meditation app prototype tailored to cancer patients/survivors unique needs including content related to cancer-related experiences, emotions, symptoms, physical and psychological needs, cancer-specific symptom self monitoring, social support and sense of belonging within the app and through Facebook.
Specific Aim 3: ASSESS (i.e., beta-test) the prototype's form and function with cancer patients/survivors (N=30). The investigators will use Bowen's feasibility model to determine via surveys and interviews: (a) acceptability (satisfaction, perceived appropriateness, perceived positive/negative effects); (b) demand (use of the app, interest or intention to use); (c) practicality (how it makes them feel, ease of use); (d) adaptation (suggestions for modifications to improve performance for cancer patients/survivors); and (e) integration (how can the app be integrated into the cancer "system") Feasibility benchmarks: >80% of cancer patients/survivors will accept the prototype, demand the prototype for themselves and other cancer patients/survivors, and find it practical. Data from Aim 3 will guide refinement of the prototype to be tested in a fully powered RCT to establish long term engagement (Phase 2). This work will result in an evidence based, cancer-specific meditation app through a commercial platform that can be scaled and sold at discounted costs to clinic providers and directly to patients (SHARE; Phase 3).
Detailed description
This STTR consists of three aims, each of which are conducted in successive order, with the end result being a cancer-specific meditation app prototype ready for efficacy testing (Phase 2) and direct marketing to the consumer (Phase 3).
Aim 1: Using the IDEAS framework, the investigators will INTEGRATE a) perspectives from an informed advisory committee (N=20) about the current Calm platform and b) strategies from the social cognitive theory to design a cancer-specific meditation app prototype. The meaning of the IDEAS stage INTEGRATE is to uncover deeper needs, values, and motivations, engaging key stakeholders (i.e., patients and providers) and use behavioral theory to inspire solutions that are more relevant and acceptable to the target population. Procedures: The advisory committee will consist of informed cancer patients, survivors (n=10; 5 of each) and healthcare providers (n=10; physicians, oncology nurses, cancer care coordinators, directors of integrative programs in cancer centers, and not-for-profit partners; See Support Letters). The advisory committee members are drawn from partnerships with Mays Cancer Center at UT Health San Antonio, MD Anderson, the Mayo Clinic in Scottsdale, AZ and Rochester, NY, University of Arizona, Wake Forest, Leukemia and Lymphoma Society, and the American Cancer Society. Both patients/survivors and providers are included on the advisory committee because providers play a key role in recommending mobile tools to patients to self-manage their symptoms, providers are often uninvolved stakeholders related to app design, and integrating apps into scalable interventions requires support of both patients/survivors and providers. The selection criteria prioritizes the cancer patient and survivor experience, but also includes members who see and hear the preferences, points of reluctance, stated and unstated barriers, and behavioral choices of those they serve in a variety of capacities (medical, ancillary, and direct provision of in-person meditation options).
The advisory committee will be asked to: (1) use the Calm app for at least 10 minutes a day for seven days to explore its content and features, (2) keep an informal journal of (a) time of day and time spent using Calm, (b) responses to app options and what motivated them to make certain choices, (c) their experiences during the guided meditations, and (d) ideas about life experiences of a cancer patient to include in prototype, (e) responses to prompts related to strategies from SCT, (e.g., in what ways might the content or features of the app support a sense of social modeling from other cancer patients or providers? How might goal setting and rewards be incorporated appropriately?) and (f) if not a cancer patient or survivor, to reflect upon the perspective of those they treat or serve, and (3) participate in a virtual focus group to provide informed, meaningful and specific input for the prototype. Focus groups have a long history in industry and marketing when the goal is to evaluate responses to products or ideas under development. Considering Coronavirus 2019, virtual focus groups will be conducted based on best-practice guidelines for internet-based qualitative research. One developer from Calm will listen to the focus groups for practical guidance and to meet target needs in the prototype design (Aim 2). The investigators will use Bowen's feasibility framework to explore specific domains of design (acceptability, demand, practicality, adaptation, and integration) (examples are open-ended experiential and cancer-referenced content explorations). The investigators believe this informed-user stage will strengthen the advisory committees' ability to direct the following design and assessment stages where they will be advisors not users. These informed-user focus groups will direct the DESIGN stage in Aim 2, by developing a list of the content and features, prioritized by numbers of mentions and importance emphasized. Milestone for Aim 1: Prioritize a list of 10-12 key content and feature issues to use in designing the prototype and promoting continued engagement.
Aim 2: Using the IDEAS framework, the investigators will DESIGN a cancer-specific meditation app prototype. IDEAS framework suggests prototyping leads to objectively stronger final products. The process includes understanding the most frequent requests, deciding on goals and non-goals, and writing out how users should interact with specific features. The investigators will use findings from Aim 1 to rapidly develop server-side Application Programming Interface (APIs) and an app for iOS. Themes and feedback from the feasibility focus groups (e.g., how to cultivate acceptance, demand, practicality, etc.) will be used to extend the current Calm design, APIs, and app so that the content, layout, and features in the app will address specific cancer-related long-term needs.
Design: The first step is to mock up user experience, user interface flows, and screens in the mobile app that fit with the values and user requirements from the focus groups. The investigators will mock and create wireframes of potential flow and solutions. The designs will be iterated based on feedback. Once the investigators have clear wireframes and specifications, they will create high-fidelity build mock ups.
API and mobile application development: The investigators will build out an interactive prototype by extending Calm's API. The API is a web interface that will help facilitate communication between the mobile application (front-end) and the software running on the server (back-end). It will allow the app to extend its functionalities by making use of other software subroutines running remotely on a server. The APIs will be REST-based and developed in JavaScript using a web framework known as Node.js with a Postgres database. The current Calm system is deployed using Kubernetes, provisioned with Terraform and hosted on Amazon Web Services. All API communication between the servers and clients is done through HTTPS (Hypertext Transfer Protocol Secure) for secure communication. The servers will handle the logic of what, where, when, and how information should be displayed. This will allow the front-end team to move more quickly, focus on user experience, user interface and beautiful animations rather than duplicating the complex business logic. The investigators can move very quickly to automatically change the way content is displayed on the server without user app updates. The API handles authentication, identity management, content, session history, subscriptions, AB test enrollment, assets, surveys and polls, onboarding flows, and scenes. The investigators also have admin endpoints that are deployed inside the virtual private cloud and are not publicly accessible. These routes power the internal tools, which support scene and program uploading, user management, admin activity logs and notes, and debugging. Thus, all aspects of the existing Calm app, from meditation tracks and content to the specific visual and selection paths, even to the inner structural workings of the app can be adapted with recommendations from Aim 1. After specifying the API changes, the investigators will change the API code and front-end app to speak to the API. This results in the prototype app specifically targeting cancer patients and survivors to be used in Aim 3. All data will be encrypted and the patient will use a password to access the app. Security and compliance standards will meet the requirements as a business associate of a healthcare provider, including HIPAA policies and procedures.
Aim 3: Using the IDEAS framework, the investigators will ASSESS (i.e., beta-test) the feasibility of the cancer-specific meditation app prototype with a sample of cancer patients/survivors (N=30). The investigators will recruit cancer patients/survivors with varying cancer types and stages, race/ethnicity, rural/urban geographic settings, and genders via social media. The investigators have 100 letters of support from cancer patients/survivors supporting the development of a cancer-specific Calm app. Studies suggest 5-10 participants are sufficient to establish feasibility and detect technical difficulties. The sample size is not to establish efficacy, but the multiple components of feasibility. The investigators have included a larger number to ensure a variety of cancer-related experiences. Beta-test participants will be asked to use the prototype for four weeks (free access) for at least 10 minutes per day, but will be encouraged to use it as much as they would like, mimicking how a new paying member would use the existing Calm app. Participation (meditations completed, time of day, length of time, components used) will be tracked (provided by Calm) over the four weeks. The 4-week period is not to establish efficacy but is an appropriate time to test feasibility. To determine acceptability, demand, and practicality, participants will be asked to complete weekly satisfaction questionnaires in addition to a final overall study satisfaction questionnaire immediately post-intervention using REDCap. Following the 4-week beta-test, and in addition to a satisfaction questionnaire the investigators will ask participants to volunteer for a semi-structured interview to determine, using Bowen's feasibility model, acceptability, demand, practicality, adaptation and integration to optimize potential for uptake, engagement and continued use at recommended levels (i.e., at least 10 min/day). Themes and findings from the interviews will be shared with the advisory committee and used to translate findings into app-relevant recommendations (i.e., further revisions if necessary) for efficacy testing (Phase 2). This approach is similar to methods used in other studies designing and developing mobile apps. Due to COVID-19, the investigators will conduct interviews virtually, based on best-practice guidelines for internet-based qualitative research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study consists of multiple phases/aims, but within each phase/aim (excluding Aim 2 as this is just app development), there is a single group assignment. The intervention model layout described herein was the most appropriate method to describe each of the involved phases and steps.
| Arm | Type | Receives |
|---|---|---|
| Calm Meditation Smartphone App Feedback (Aim 1) | Other | Other: Calm Meditation Smartphone App FeedbackAdvisory committee members will be asked to use the current Calm meditation app platform for a full week and to keep an informal journal prior to participating in focus groups in which they will provide feedback about the app. |
| Cancer-Specific Meditation App Prototype Design (Aim 2) | Other | Other: Cancer-Specific Meditation App Prototype DesignFindings from Aim 1 will inform the development of a cancer-specific meditation app prototype to be tested in Aim 3. |
| Cancer-Specific Meditation App Prototype (Aim 3) | Other | Device: Cancer-Specific Meditation App PrototypeRecruited cancer patients/survivors will be asked to beta-test the cancer-specific app prototype for four weeks. The prototype will be developed in Aim 2 and informed by qualitative findings of Aim 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calm Meditation Smartphone App FeedbackAdvisory committee members will be asked to use the current Calm meditation app platform for a full week and to keep an informal journal prior to participating in focus groups in which they will provide feedback about the app. | Other | Calm Meditation Smartphone App Feedback (Aim 1) |
| Cancer-Specific Meditation App Prototype DesignFindings from Aim 1 will inform the development of a cancer-specific meditation app prototype to be tested in Aim 3. | Other | Cancer-Specific Meditation App Prototype Design (Aim 2) |
| Cancer-Specific Meditation App PrototypeRecruited cancer patients/survivors will be asked to beta-test the cancer-specific app prototype for four weeks. The prototype will be developed in Aim 2 and informed by qualitative findings of Aim 1. | Device | Cancer-Specific Meditation App Prototype (Aim 3) |
Primary outcome
Aim 1: Feasibility: Acceptability as assessed with focus groups
Time frame: Questions asked at one week of use of the current Calm platform
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Feasibility: Demand as assessed with focus groups
Time frame: Questions asked at one week of use of the current Calm platform
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Aim 1: Feasibility: Practicality as assessed with focus groups
Time frame: Questions asked at one week of use of the current Calm platform
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Aim 1: Feasibility: Adaptation as assessed with focus groups
Time frame: Questions asked at one week of use of the current Calm platform
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Aim 1: Feasibility: Integration as assessed with focus groups
Time frame: Questions asked at one week of use of the current Calm platform
Integration is defined as Integration degree of execution, amount and type of resources needed to implement, factors affecting ease of implementation according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Acceptability as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 1
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Acceptability as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 2
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Acceptability as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 3
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Acceptability as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 4
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Acceptability as assessed with survey
Time frame: Questions will be asked with a post-intervention (week 4) satisfaction survey
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Acceptability as assessed with interview
Time frame: Questions will be asked with a post-intervention (week 4) structured interview
Acceptability is defined as satisfaction, intent to continue to use, perceived appropriateness according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Demand as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 1
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Demand as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 2
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Demand as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 3
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Demand as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 4
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Demand as assessed with survey
Time frame: Questions will be asked with a post-intervention (week 4) survey
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Demand as assessed with interview
Time frame: Questions will be asked with a post-intervention (week 4) structured interview
Demand is defined as actual use, expressed interest or intention to use, perceived demand according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Demand captured via Calm-provided data
Time frame: Calm-provided data capturing meditation participation at post-intervention (week 4)
Calm will track weekly minutes of meditation participation for each participant.
Aim 3: Feasibility: Practicality as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 1
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Practicality as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 2
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Practicality as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 3
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Practicality as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 4
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Practicality as assessed with survey
Time frame: Questions will be asked with a post-intervention (week 4) survey
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Practicality as assessed with interview
Time frame: Questions will be asked with a post-intervention (week 4) structured interview
Practicality is defined as ability of participants to carry out intervention activities, efficiency/speed/quality of implementation according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Adaptation as assessed with survey
Time frame: Questions will be asked with a weekly satisfaction survey (week 1 to week 4)
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Adaptation as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 1
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Adaptation as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 2
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Adaptation as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 3
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Adaptation as assessed with survey
Time frame: Questions will be asked with a satisfaction survey after week 4
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Adaptation as assessed with interview
Time frame: Questions will be asked with a post-intervention (week 4) structured interview
Adoption is defined as how to promote improvement according to Bowen and colleagues feasibility criteria.
Aim 3: Feasibility: Integration as assessed with survey
Time frame: Questions will be asked with a post-intervention (week 4) survey
Integration is defined as Integration degree of execution, amount and type of resources needed to implement, factors affecting ease of implementation according to Bowen and colleagues feasibility criteria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Derived from this study: PubMed 36416880Huberty J, Bhuiyan N, Puzia M, Joeman L, Larkey L, Mesa R. Meditation Mobile App Developed for Patients With and Survivors of Cancer: Feasibility Randomized Controlled Trial. JMIR Cancer. 2022 Nov 23;8(4):e39228. doi: 10.2196/39228.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calm Meditation Smartphone App Feedback, Cancer-Specific Meditation App Prototype Design and Cancer-Specific Meditation App Prototype in people with Cancer, run by Calm.com, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Feasibility: Acceptability as assessed with focus groups (time frame: Questions asked at one week of use of the current Calm platform). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05459168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.