Clinical trial NCT06923501: Evaluation of a Mobile App Program for Coping With Cancer
Official title: Feasibility, Acceptability, and Preliminary Outcomes of a Mobile App for Coping With Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: mobile application
app
cancer
coping
quality of life
distress
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Participant interest
timeFrame: Up to 12 months
measure: Accrual
timeFrame: Up to 12 months
measure: Participant completion
timeFrame: Up to 12 months
measure: Participant satisfaction
timeFrame: Up to 18 months
measure: Helpfulness
timeFrame: Up to 18 months
measure: Acceptability
timeFrame: Up to 18 months
measure: Usage
timeFrame: Up to 18 months
Secondary outcomes:
measure: Depression
timeFrame: Up to 18 months
measure: Anxiety
timeFrame: Up to 18 months
measure: Adaptive Coping
timeFrame: Up to 18 months
measure: Health Related Quality of Life
timeFrame: Up to 18 months
measure: Psychological Flexibility
timeFrame: Up to 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Gabriel Cartagena, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.