Development of Calm for Cancer Prototype Mobile App

NCT05459168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-07-14

No results posted yet for this study

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

Interventions

OTHER

Calm Meditation Smartphone App Feedback

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

Cancer-Specific Meditation App Prototype Design

Findings from Aim 1 will inform the development of a cancer-specific meditation app prototype to be tested in Aim 3.

DEVICE

Cancer-Specific Meditation App Prototype

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    collaborator OTHER
  • Arizona State University

    collaborator OTHER
  • Calm.com, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-02-28
Completion
2022-03-15

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05459168 on ClinicalTrials.gov