Lung Cancer
Conditions
Keywords
Anxiety, Mindfulness Apps, 23-114
Brief summary
The purpose of this study is to find out if it is practical to provide the program contained within the smartphone app AmDTx before and after lung cancer surgery. AmDTx is a platform that re-configures according to the specific needs of patients through physician prescriptions.
Interventions
OTHERAmDTx-PCSP
Step-by-step program modules including meditation training and other activities relevant for people living with cancer
OTHERAmDTx-2048
Cognitive training exercise called 2048.AmDTx-2048 is a modified version of a popular game called 2048. It is a fun and relaxing puzzle game. Within 2048, participants slide numbered tiles around a grid, matching tiles of the same value.
OTHERQuestionnaires
Distress Thermometer (DT)2, Demographic Information and medical history, Assessment for Contamination, Impact of Event Score (IES-R), Mindfulness Attention Awareness Scale (MAAS), PROMIS Short Form v1.0 - Anxiety - 8a, Depression - 4a, Fatigue 4a, Sleep Disturbance 4a, The Lung Cancer Stigma Inventory (LCSI)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A prospective randomized pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven lung cancer * Patients with suspected primary lung cancer per recent chest CT scan (with or without contrast) may be enrolled in the trial. These patients may be randomized and begin study intervention without a biopsy. If a patient undergoes a biopsy after consent and the results are negative or if the patient does not proceed with surgery, the patient will be removed from the study. The patient will continue to receive full access to the AmDTx app for 2-years. * Scheduled for surgery with at least 14 days lead time (to allow the participant to start the mindfulness practice \[intervention group\] 14 days preoperatively) * Age ≥18 years of age at time of signing informed consent * Access to a smartphone/tablet with data connection * Willing to give time for mindfulness practice (Patients need to have the motivation to devote approximately 20 to 30 min daily, which is equal to 5 to 7 sessions a week over the course of a minimum of 6 weeks to do the mindfulness meditations and practices) * Willing to be randomized to mindfulness MBCR or CI group and complete all assessments * High distress level (Distress Thermometer score ≥4 at initial visit) * Able to understand the study objectives and procedures, comply with the protocol, and sign an informed consent * Able to read, speak, and understand English
Exclusion criteria
* Currently engaging in app-based mindfulness or meditation for one or more times per week * As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility before consent * Individuals with impaired decision-making capacity * Patients that need to undergo neoadjuvant therapy (chemotherapy±radiation) * Patients undergoing active treatment of other non-lung cancers * Patients with recurrent lung cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence Retention rate | up to 3 months | Retention rates will be calculated separately as the proportion of enrolled participants who complete the 4-week and 3-month follow-up surveys. Adherence: The AmDTx app automatically collects adherence data, including date, time, length, and name of session to which participants listened, and transfers the data to the researchers on a weekly basis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in anxiety symptoms | up to 6 months | These analyses apply to all continuous endpoints (PROMIS-Anxiety, IES, MAAS, PROMIS- Depression, PROMIS-Fatigue, PROMIS-Sleep Disturbance, LCSI) |
Countries
United States
Outcome results
None listed