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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Participants will be asked to use a 13-session self-management program "Tools for Coping with Cancer" within the Calm Health mobile app.
Participant interest
The number of individuals who initiate evaluating eligibility.
Time frame: Up to 12 months
Accrual
The number of individuals who provide consent.
Time frame: Up to 12 months
Participant completion
The number of individuals who complete all sessions of the program.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to 18 months
Usage
Participant usage of the app, including frequency and duration of session play will be captured.
Time frame: Up to 18 months
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Up to 18 months
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