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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Participant interest [Time frame: Up to 12 months]
• Accrual [Time frame: Up to 12 months]
• Participant completion [Time frame: Up to 12 months]
• Participant satisfaction [Time frame: Up to 18 months]
• Helpfulness [Time frame: Up to 18 months]
• Acceptability [Time frame: Up to 18 months]
• Usage [Time frame: Up to 18 months]

Secondary outcome measures (5)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Smilow Cancer Hospital — New Haven

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. PMID 25793945

Identifiers

NCT: NCT06923501 · 2000037763

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗