Evaluation of a Mobile App Program for Coping With Cancer

Study Purpose

The goal of this clinical trial is to learn if a mobile app program for people with a history of cancer can help treat distress. The main questions it aims to answer is: Do participants use the Tools for Coping with Cancer Calm Health mobile app and do they find it helpful? Does the Tools for Coping with Cancer Calm Health mobile app improve mood, quality of life, and help with coping? Participants will be asked to use a 13-session self-management program (Tools for Coping with Cancer) housed within the Calm Health app. Participants will use this app on their own device, in their own home. Participants will have access to the program for 8 weeks and will be asked to work their way through the program at their own pace. Participants will be asked to complete questionnaires about their mood, quality of life, coping, and experience with the app three times: at the start of the study, after 8 weeks using the app, and then 3-months after using the app.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Stated willingness to comply with all study procedures and availability for the duration of the study (8 weeks active intervention and 3-month follow up) - Have a confirmed diagnosis of cancer; or have been treated for cancer within the last two years, including adjuvant therapies.

- Over the age of 18.

- Able to understand and read English.

- Able to navigate a mobile app with minimal assistance from study staff.

- Able to provide informed consent.

Exclusion Criteria:

- Are taking part in psychotherapy at any time during the study.

- Have an un-treated or under-treated mental health disorder based on pre-study screening that may require a referral to individual mental health care.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06923501
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Yale University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Gabriel Cartagena, PhD
Principal Investigator Affiliation	Yale University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cancer

Additional Details

The purpose of this study is to evaluate the feasibility, acceptability, and preliminary effectiveness of a self-management mobile app on mood, quality of life, psychological flexibility, and adaptive coping in a population of people with cancer. The intention of this research is to meet the most common unmet supportive care needs such as anxiety and depression, pain, insomnia, and fear of cancer recurrence utilizing evidence-based intervention that is accessible and self-paced. We hypothesize that the Tools for Coping with Cancer mobile app program will: 1. Be feasible and acceptable to participants, as rated by interest, accrual, and completion rates, acceptability ratings, and participant satisfaction with the program. 2. Have a statistically significant effect on symptoms of depression, anxiety, psychological flexibility, adaptive coping, and quality of life. We further hypothesize that these improvements will be retained at 3-months post-intervention. The primary objective is to determine the feasibility and acceptability of a self-management mobile app intervention as measured by participant interest, accrual, completion, satisfaction, acceptability, and app usage. The secondary objective is to evaluate preliminary outcomes related to mood, quality of life, psychological flexibility, and adaptive coping, and will be measured using self-report questionnaires. This is a prospective pilot feasibility, acceptability, and effectiveness study. The intervention is a 13-session self-management program housed within the Calm Health app. Participants will have access to the program for 8 weeks and will be asked to work their way through the program at their own pace. Participants will complete a series of self-report surveys to evaluate the primary and secondary objectives of the study. Additionally, researchers will have access to data reporting participant's usage patterns of the app, including the frequency and duration of session play.

Arms & Interventions

Arms

Experimental: Mobile App Intervention

Participants will be asked to use the 13-session Coping with Cancer Program in a mobile app.

Interventions

Device: - Tools for Coping with Cancer Calm Health mobile app program

Participants will be asked to use a 13-session self-management program "Tools for Coping with Cancer" within the Calm Health mobile app.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Gabriel Cartagena, PhD

[email protected]

516-855-8539

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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