Evaluation of a Mobile App Program for Coping With Cancer

Feasibility, Acceptability, and Preliminary Outcomes of a Mobile App for Coping With Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: Tools for Coping with Cancer Calm Health mobile app program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriel Cartagena, PhD; Phone Number: 516-855-8539; Email: gabriel.cartagena@yale.edu
• Study Contact Backup: Name: Jennifer Kilkus, PhD; Email: jennifer.kilkus@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile App Intervention; 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; Participants will be asked to use a 13-session self-management program "Tools for Coping with Cancer" within the Calm Health mobile app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Will be measured using: Patient Health Questionnaire-9; a 9-item scale evaluating the frequency of depression symptoms over a two week period. Minimum score: 0 Maximum score: 27 Higher score = worse outcome	Up to 18 months
Anxiety	Will be measured using: Generalized Anxiety Disorder-7; a 7-item scale evaluating the frequency of anxiety symptoms over a two week period. Minimum score: 0 Maximum score: 21 Higher score = worse outcome	Up to 18 months
Adaptive Coping	Will be measured using the Brief COPE, a 28-item measure of coping in response to stressful situations. Minimum score: 28 Maximum score: 112 Outcome depends on the score of each subscale, of which there are 14. Some subscales reflect adaptive coping, while others reflective maladaptive coping.	Up to 18 months
Health Related Quality of Life	Will be measured by the FACT-G (Functional Assessment of Cancer Therapy, General), a 27-item questionnaire designed to measure four domains of health related quality of life in people with cancer: Physical, social, emotional, and functional well-being. Minimum score: 108 Maximum score: 0 Higher scores indicate better outcome	Up to 18 months
Psychological Flexibility	Will be measured by the Brief Experiential Avoidance Questionnaire, a 15-item questionnaire measuring willingness to remain in contact with distressing emotions, memories, thoughts, and physical sensations. Minimum score: 15 Maximum score: 90 Higher scores indicate worse outcomes	Up to 18 months

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Gabriel Cartagena, PhD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; cancer; coping; distress; mobile application; app
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Neoplasms; Alzheimer Disease
• Other Study ID Numbers: 2000037763

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study limited to one site. No need to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No