Development of Calm for Cancer Prototype Mobile App

NCT05459168 | Completed DMC

• 1 other identifier: STUDY00013029
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (31)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Questions will be asked with a post-intervention (week 4) survey

Study Arms (3)

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.

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.

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.

Device: Cancer-Specific Meditation App Prototype

Interventions

Calm Meditation Smartphone App Feedback 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.

Calm Meditation Smartphone App Feedback (Aim 1)

Cancer-Specific Meditation App Prototype Design OTHER

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 Prototype Design (Aim 2)

Cancer-Specific Meditation App Prototype DEVICE

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.

Cancer-Specific Meditation App Prototype (Aim 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Calm.com, Inc.: lead
• The University of Texas Health Science Center at San Antonio: collaborator
• Arizona State University: collaborator

Study Sites (1)

Calm, Inc.

San Francisco, California, 94108, United States

Location

Related Publications (1)

• 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.

  PMID: 36416880 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: July 14, 2022
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 15, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)