跳至主要内容
临床试验/NCT05459168
NCT05459168已完成不适用

Leveraging an Academic-Industry Partnership to Develop a Cancer-Specific Mobile Meditation App

Calm.com, Inc.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Aim 3: Feasibility: Demand as assessed with interview

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Aim 3: Feasibility: Demand as assessed with interview

时间窗: 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: Adaptation as assessed with interview

时间窗: 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.

Feasibility: Demand as assessed with focus groups

时间窗: 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

时间窗: 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 3: Feasibility: Demand as assessed with survey

时间窗: 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: Practicality as assessed with survey

时间窗: 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

时间窗: 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 1: Feasibility: Integration as assessed with focus groups

时间窗: 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: Adaptation as assessed with survey

时间窗: 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 1: Feasibility: Acceptability as assessed with focus groups

时间窗: 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.

Aim 1: Feasibility: Adaptation as assessed with focus groups

时间窗: 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 3: Feasibility: Demand captured via Calm-provided data

时间窗: 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: Acceptability as assessed with survey

时间窗: 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

时间窗: 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: Integration as assessed with survey

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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