Recruiting

Calm Health

Sponsor:

Yale University

Code:

NCT06923501

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tools for Coping with Cancer Calm Health mobile app program

Study Details

Brief summary:

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.

Conditions

Cancer

Study ID

NCT06923501

Start date

Jun 11, 2026

Status verified date

Jun, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Mobile App Intervention

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

Interventions

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.

Primary outcome measure

  • Participant interest [ Time Frame: Up to 12 months ]
  • Accrual [ Time Frame: Up to 12 months ]
  • Participant completion [ Time Frame: Up to 12 months ]
  • Participant satisfaction [ Time Frame: Up to 18 months ]
  • Helpfulness [ Time Frame: Up to 18 months ]
  • Acceptability [ Time Frame: Up to 18 months ]
  • Usage [ Time Frame: Up to 18 months ]

Central Contacts and Locations

Central contacts

Gabriel Cartagena, PhD

516-855-8539gabriel.cartagena@yale.edu

Jennifer Kilkus, PhD

jennifer.kilkus@yale.edu

Locations

Smilow Cancer Hospital

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Gabriel Cartagena, PhD

516-855-8539gabriel.cartagena@yale.edu

More Information

Sponsor

Yale University

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • mobile application
  • app
  • cancer
  • coping
  • quality of life
  • distress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-15.