NCT05459168

Development of Calm for Cancer Prototype Mobile App

Completed NA Last updated 14 July 2022

What this trial tests

NA trial testing Calm Meditation Smartphone App Feedback in Cancer in 50 participants. Completed in 15 March 2022.

Timeline

1 March 2021

Primary endpoint
28 February 2022

15 March 2022

Quick facts

Lead sponsor	Calm.com, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	50
Start date	1 March 2021
Primary completion	28 February 2022
Estimated completion	15 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Calm Meditation Smartphone App Feedback
• Cancer-Specific Meditation App Prototype Design
• Cancer-Specific Meditation App Prototype

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Calm.com, Inc.

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Meditation Mobile App Developed for Patients With and Survivors of Cancer: Feasibility Randomized Controlled Trial.
   Huberty J, Bhuiyan N, Puzia M, Joeman L, et al · · 2022 · cited 3× · PMID 36416880 · DOI 10.2196/39228