Study Stopped
Study was never submitted to the IRB so never received permission to or enrolled any subjects
Calm for Cancer Patients Receiving Chemotherapy
Can a Mindfulness Meditation App Reduce Emotional Distress in Colorectal Cancer Patients Undergoing Adjuvant Chemotherapy
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
Chemotherapy is a common strategy used to treat colorectal cancer patients, but is often leads patients and survivors to experience a host of symptoms, of which acute emotional distress is a major concern. Smartphone-based meditation via an already-developed app (i.e., Calm) is a unique and novel way of providing a potentially helpful symptom-management strategy to colorectal cancer patients and survivors both during their chemotherapy treatment sessions for the management of distress and between treatment sessions for the management of other more chronic symptoms. Our hypothesis is that colorectal cancer patients using the Calm smartphone app throughout their chemotherapy treatment will see lower psychological distress during individual chemotherapy treatment sessions, greater chemotherapy tolerability, lower chemotherapy toxicity symptoms, lesser fatigue, and higher quality of life as compared to a usual care control group. Colorectal cancer patients (N=30) will be randomly assigned to an intervention (n=15) or control group (n=15) for the duration of their chemotherapy treatment, with study outcome measurement occurring throughout their treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 31, 2022
December 1, 2021
1 year
April 9, 2020
March 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Distress
Distress will be measured with the Distress Thermometer at the beginning and end of each chemotherapy treatment session over the course of the approximate 6-month study duration. The Distress Thermometer is a 10-point visual analog scale and a higher score indicates greater distress.
6-month average change from baseline (beginning of chemotherapy treatment session) to post-treatment (end of chemotherapy treatment session)
Secondary Outcomes (4)
Chemotherapy toxicity and tolerability
Post-intervention (month 6)
Change in Fatigue
Change from baseline (week 0) to post-intervention (month 6)
Change in Cancer Treatment-Related Quality of Life
Change from baseline (week 0) to post-intervention (month 6)
Change in Cancer Health-Related Quality of Life
Change from baseline (week 0) to post-intervention (month 6)
Study Arms (2)
Calm Meditation
EXPERIMENTALParticipants in the Calm group will be asked to use the Calm app ad libitum during their time spent receiving chemotherapy at the Mays Cancer Center (\~2 hours) and while at home between treatment cycles ad libitum. Participation will be measured during the entire intervention using internal tracking systems within the app (i.e., # of times logged in, type of meditation accessed, time spent meditating, date and time of meditation accessed). This data will be provided to us through data coordinator of the app.
Usual Care
NO INTERVENTIONThe usual care control group will not be offered anything to listen to during their chemotherapy treatment cycles or when they are between chemotherapy treatment cycles. They will receive their treatment as intended without any additional intervention.
Interventions
The Calm Meditation Mobile App will be used to deliver the meditation intervention to study participants. The Calm app is downloaded onto the participant's smartphone.
Eligibility Criteria
You may qualify if:
- Have a colorectal cancer diagnosis and waiting the beginning of adjuvant chemotherapy treatment at the Mays Cancer Center University of Texas (UT) Health San Antonio
- Own a mobile smartphone (iPhone with iOS 9.0 or later or an Android 4.1 or later)
- Willing to download a mobile app
- Able to read and understand English or Spanish
- Aged 18 years or older
- Willing to be randomized to one of two groups
You may not qualify if:
- Meditation or meditative movement practice (i.e., yoga, tai chi, qigong) of greater than or equal to 60 min/month in the past six months
- Use of any consumer-based meditation app
- Reside outside of the united states
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruben Mesa
Mays Cancer Center at UT Health San Antonio MD Anderson
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2020
First Posted
April 15, 2020
Study Start
February 1, 2022
Primary Completion
February 1, 2023
Study Completion
December 1, 2023
Last Updated
March 31, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share