CancerNCT06923501
Evaluation of a Mobile App Program for Coping With Cancer
A study testing Tools for Coping with Cancer Calm Health mobile app program in people with Cancer, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Tools for Coping with Cancer Calm Health mobile app program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Kilkus, PhD contact
United States1 site, 1 recruiting
- Recruiting
Smilow Cancer Hospital
New Haven, Connecticut, 06519
Gabriel Cartagena, PhD, 516-855-8539, gabriel.cartagena@yale.edu
About this study
Official title: 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?
Read more
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.
Read the 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:
- Be feasible and acceptable to participants, as rated by interest, accrual, and completion rates, acceptability ratings, and participant satisfaction with the program.
- 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.
- Conditions
- Cancer
- Being tested
- Tools for Coping with Cancer Calm Health mobile app program
- Keywords
- mobile application, app, cancer, coping, quality of life, distress
- Medical subject headings
- Neoplasms, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tools for Coping with Cancer Calm Health mobile app programDevice
Participants will be asked to use a 13-session self-management program "Tools for Coping with Cancer" within the Calm Health mobile app.
| Study group | Role | What they receive |
|---|---|---|
| Mobile App Intervention | Experimental | Participants will be asked to use the 13-session Coping with Cancer Program in a mobile app. Receives: Device: Tools for Coping with Cancer Calm Health mobile app program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant interest
The number of individuals who initiate evaluating eligibility.
Measured: Up to 12 months
Accrual
The number of individuals who provide consent.
Measured: Up to 12 months
Participant completion
The number of individuals who complete all sessions of the program.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 18 months
Usage
Participant usage of the app, including frequency and duration of session play will be captured.
Measured: Up to 18 months
Secondary outcomes (5)
Depression
Will be measured using:
Patient Health Questionnaire-8; a 8-item scale evaluating the frequency of depression symptoms over a two week period.
Minimum score: 0 Maximum score: 24 Higher score = worse outcome
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start11 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Cartagena, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923501
- Sponsor's protocol ID
- 2000037763
- Status last verified
- Jun 2026
- First submitted
- 23 Mar 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study limited to one site. No need to share data.
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.
PubMed 25793945
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Outcomes of a Mobile App for Coping With Cancer
- ClinicalTrials.gov ID
- NCT06923501
- Acronym / sponsor ID
- 2000037763
- Conditions
- Cancer
- Keywords
- mobile application, app, cancer, coping, quality of life, distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Be feasible and acceptable to participants, as rated by interest, accrual, and completion rates, acceptability ratings, and participant satisfaction with the program.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile App Intervention | Experimental | Device: Tools for Coping with Cancer Calm Health mobile app programParticipants will be asked to use the 13-session Coping with Cancer Program in a mobile app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tools for Coping with Cancer Calm Health mobile app programParticipants will be asked to use a 13-session self-management program "Tools for Coping with Cancer" within the Calm Health mobile app. | Device | Mobile App Intervention |
Primary outcome
Participant interest
Time frame: Up to 12 months
The number of individuals who initiate evaluating eligibility.
Accrual
Time frame: Up to 12 months
The number of individuals who provide consent.
Participant completion
Time frame: Up to 12 months
The number of individuals who complete all sessions of the program.
Participant satisfaction
Time frame: Up to 18 months
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.
Helpfulness
Time frame: Up to 18 months
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.
Acceptability
Time frame: Up to 18 months
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
Usage
Time frame: Up to 18 months
Participant usage of the app, including frequency and duration of session play will be captured.
5 secondary outcomes
Depression
Time frame: Up to 18 months
Anxiety
Time frame: Up to 18 months
Adaptive Coping
Time frame: Up to 18 months
Health Related Quality of Life
Time frame: Up to 18 months
Psychological Flexibility
Time frame: Up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 25793945Agboola 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.
- Individual participant dataSharing planned: No. Study limited to one site. No need to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Kilkus, PhD contact
Gabriel Cartagena, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tools for Coping with Cancer Calm Health mobile app program in people with Cancer, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Cartagena, PhD (516-855-8539, gabriel.cartagena@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant interest (time frame: Up to 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06923501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.