Evaluation of a Mobile App Program for Coping With Cancer

NCT06923501 | Not Yet Recruiting

• 1 other identifier: 2000037763
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Participant interest

  The number of individuals who initiate evaluating eligibility.

  Up to 12 months

• Accrual

  The number of individuals who provide consent.

  Up to 12 months

• Participant completion

  The number of individuals who complete all sessions of the program.

  Up to 12 months

• Participant satisfaction

  A Likert-type scale ranging from very dissatisfied to very satisfied on the program overall as well as each session. Minimum value: 0 (not at all satisfied) Maximum value: 140 (Very satisfied with the program as a whole; very satisfied with each individual session) Lower numbers indicate worse outcome.

  Up to 18 months

• Helpfulness

  A Likert-type scale ranging from very unhelpful to very unhelpful on the program overall as well as each session. Minimum value: 0 (not at all helpful) Maximum value: 140 (Found program as a whole and each individual session very helpful). Lower numbers indicate worse outcome.

  Up to 18 months

• Acceptability

  A 10-item acceptability questionnaire (Theoretical Framework of Acceptability) evaluating affective attitude, burden, ethicality, perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, and general acceptability. Minimum value: 0 Maximum value: 100 Higher score indicates greater acceptability

  Up to 18 months

• Usage

  Participant usage of the app, including frequency and duration of session play will be captured.

  Up to 18 months

Secondary Outcomes (5)

• Depression

  Up to 18 months

• Anxiety

  Up to 18 months

• Adaptive Coping

  Up to 18 months

• Health Related Quality of Life

  Up to 18 months

• Psychological Flexibility

  Up to 18 months

Study Arms (1)

Mobile App Intervention

EXPERIMENTAL

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

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

Interventions

Tools for Coping with Cancer Calm Health mobile app program DEVICE

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

Mobile App Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Related Publications (1)

• Agboola SO, Ju W, Elfiky A, Kvedar JC, Jethwani K. The effect of technology-based interventions on pain, depression, and quality of life in patients with cancer: a systematic review of randomized controlled trials. J Med Internet Res. 2015 Mar 13;17(3):e65. doi: 10.2196/jmir.4009.

  PMID: 25793945 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Gabriel Cartagena, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Cartagena, PhD

CONTACT

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

Jennifer Kilkus, PhD

CONTACT

jennifer.kilkus@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 11, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share