Cancer ColorectalNCT04345952
Calm for Cancer Patients Receiving Chemotherapy
A study testing Calm Meditation Mobile App in people with Cancer Colorectal, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Colorectal
- What is being tested?
- Calm Meditation Mobile App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Can a Mindfulness Meditation App Reduce Emotional Distress in Colorectal Cancer Patients Undergoing Adjuvant Chemotherapy
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.
Read the detailed description
Chemotherapy is a common treatment modality among colorectal cancer patients. Despite improvements in survival among those receiving chemotherapy, patients often experience side effects including pain, nausea, vomiting, changes in appetite and weight, fatigue, depressed mood, and reduced quality of life. Colorectal cancer patients undergoing chemotherapy also experience acute elevation in psychological distress (e.g., anxiety, stress). Worldwide, as many as 40% of cancer patients currently report using complementary and alternative medicine (CAM) for the management of their diagnosis and treatment-related side effects. Evidence to support the efficacy of various CAM approaches is still in its infancy, and further research is warranted.
Mindfulness-based strategies, a popular CAM approach among cancer patients, may have unique benefits for addressing both treatment-related side effects as well as the management of acute levels of psychological distress experienced while undergoing chemotherapy. Preliminary evidence supports the benefits of meditation, relaxing sounds, and progressive muscle relaxation for the reduction of distress and state anxiety as well as the improvement of neuroendocrine responses, indicative of improved stress response, among cancer patients undergoing chemotherapy. Additionally, meditation has been shown to improve distress, cognitive function, mental health, quality of life, and chemotherapy-related neurotoxicity symptoms among cancer patients that had undergone chemotherapy treatment. Despite preliminary evidence to support mindfulness-based strategies to help cancer patients undergoing chemotherapy, further research is needed to determine their efficacy.
Smartphone applications (apps) are a unique mode of delivering mindfulness-based strategies to cancer patients and may help make CAM more accessible to cancer patients reporting barriers to participation in in-person interventions (e.g., pain, fatigue, transportation, scheduling difficulties, etc.). Additionally, smartphone apps are a way of providing mindfulness-based strategies to patients while undergoing chemotherapy without the need of specialized personnel to lead mindfulness-based sessions for patients in the clinic. Smartphone accessibility is becoming more ubiquitous, with nearly three quarters of cancer patients reporting access to a mobile smartphone. To our knowledge there have been no studies that have tested the effects of meditation delivered specifically via a smartphone app to cancer patients undergoing chemotherapy (one study used an iPad). The investigators have previously demonstrated the feasibility and preliminary effects of delivering four weeks of smartphone-based meditation (via the Calm app) to hematological cancer patients to improve symptom burden. However, these patients were not undergoing chemotherapy. A meditation app such as Calm could be used to deliver mindfulness-based strategies to cancer patients undergoing chemotherapy while in clinic and outside of clinic for the management of acute psychological distress and chemotherapy-related side effects.
The Calm app has over 2 million paying users and 65 million downloads, and was named Apple's "App of the Year" in 2017.9,10 The Calm app was developed based on tenets of mindfulness and cognitive behavioral therapy, and provides its users with a range of mindfulness-based options to choose from, including meditations, Sleep Stories, and Soundscapes. In the proposed study, the investigators will investigate the use of Calm among a small sample of colorectal cancer patients (N=30; n=15 per group) who are beginning adjuvant chemotherapy within 12-weeks post-surgery as compared to a usual care control group to determine its effects on acute psychological distress within a single chemotherapy session as well as chemotherapy-related side effects.
STUDY OBJECTIVES
Objective 1: Investigate the effects of using a meditation app to reduce psychological distress (measured using the Distress Thermometer), across multiple chemotherapy sessions (n=15) among colorectal cancer patients as compared to usual control (n=15).
The primary hypothesis for this objective is that those using a meditation app will experience a reduction in psychological distress from beginning to end of each chemotherapy session as compared to usual care.
Objective 2: Investigate the effects of using a meditation app on chemotherapy toxicity and tolerability (measured using patient medical records; dose reduction/modification, dose delays, # of cycles completed, hospitalization, cytopenias, etc.), fatigue (measured using the Brief Fatigue Inventory), and quality of life (measured using the General Version of the Functional Assessment of Cancer and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) among colorectal cancer patients during a chemotherapy treatment cycle (i.e., two-three week cycle between the sessions) as compared to a usual care control group.
The primary hypothesis for this objective is that those using the meditation app will experience less severe chemotherapy toxicity, greater chemotherapy tolerability, less fatigue, and greater quality of life as compared to the usual care control group.
- Conditions
- Cancer Colorectal
- Being tested
- Calm Meditation Mobile App
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm Meditation Mobile AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Calm Meditation | Experimental | Participants 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. Receives: Behavioral: Calm Meditation Mobile App |
| Usual Care | No intervention | The 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Chemotherapy toxicity and tolerability will be assessed through patient medical records by pulling the following variables from their record: dose reduction/modification, dose delays, # of cycles completed, hospitalization, cytopenias
Measured: Post-intervention (month 6)
Change in Fatigue
Fatigue will be measured with the Brief Fatigue Inventory (BFI). The score on the BFI ranges from 0-90 with a higher score indicating a higher amount of fatigue being measured.
Measured: Change from baseline (week 0) to post-intervention (month 6)
Change in Cancer Treatment-Related Quality of Life
Cancer Treatment-Related Quality of Life will be measured with the General Version of the Functional Assessment of Cancer. The Scale is scored on a 0-100 normalized scale with a higher score indicating a higher quality of life.
Measured: Change from baseline (week 0) to post-intervention (month 6)
Change in Cancer Health-Related Quality of Life
Cancer Health-Related Quality of Life will be measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. The scale scoring ranges from 0-100 with a higher score indicating a higher quality of life.
Measured: Change from baseline (week 0) to post-intervention (month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study startFeb 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study was never submitted to the IRB so never received permission to or enrolled any subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColorectalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Sponsor
- Investigators
- Ruben Mesa, Principal investigator, Mays Cancer Center at UT Health San Antonio MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345952
- Sponsor's protocol ID
- CTMS# 20-0117
- Other IDs
- HSC20200636H
- Status last verified
- Dec 2021
- First submitted
- 9 Apr 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Mindfulness Meditation App Reduce Emotional Distress in Colorectal Cancer Patients Undergoing Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04345952
- Acronym / sponsor ID
- CTMS# 20-0117
- Conditions
- Cancer Colorectal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never submitted to the IRB so never received permission to or enrolled any subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Apr 2020 (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.
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.
Detailed description
Chemotherapy is a common treatment modality among colorectal cancer patients. Despite improvements in survival among those receiving chemotherapy, patients often experience side effects including pain, nausea, vomiting, changes in appetite and weight, fatigue, depressed mood, and reduced quality of life. Colorectal cancer patients undergoing chemotherapy also experience acute elevation in psychological distress (e.g., anxiety, stress). Worldwide, as many as 40% of cancer patients currently report using complementary and alternative medicine (CAM) for the management of their diagnosis and treatment-related side effects. Evidence to support the efficacy of various CAM approaches is still in its infancy, and further research is warranted.
Mindfulness-based strategies, a popular CAM approach among cancer patients, may have unique benefits for addressing both treatment-related side effects as well as the management of acute levels of psychological distress experienced while undergoing chemotherapy. Preliminary evidence supports the benefits of meditation, relaxing sounds, and progressive muscle relaxation for the reduction of distress and state anxiety as well as the improvement of neuroendocrine responses, indicative of improved stress response, among cancer patients undergoing chemotherapy. Additionally, meditation has been shown to improve distress, cognitive function, mental health, quality of life, and chemotherapy-related neurotoxicity symptoms among cancer patients that had undergone chemotherapy treatment. Despite preliminary evidence to support mindfulness-based strategies to help cancer patients undergoing chemotherapy, further research is needed to determine their efficacy.
Smartphone applications (apps) are a unique mode of delivering mindfulness-based strategies to cancer patients and may help make CAM more accessible to cancer patients reporting barriers to participation in in-person interventions (e.g., pain, fatigue, transportation, scheduling difficulties, etc.). Additionally, smartphone apps are a way of providing mindfulness-based strategies to patients while undergoing chemotherapy without the need of specialized personnel to lead mindfulness-based sessions for patients in the clinic. Smartphone accessibility is becoming more ubiquitous, with nearly three quarters of cancer patients reporting access to a mobile smartphone. To our knowledge there have been no studies that have tested the effects of meditation delivered specifically via a smartphone app to cancer patients undergoing chemotherapy (one study used an iPad). The investigators have previously demonstrated the feasibility and preliminary effects of delivering four weeks of smartphone-based meditation (via the Calm app) to hematological cancer patients to improve symptom burden. However, these patients were not undergoing chemotherapy. A meditation app such as Calm could be used to deliver mindfulness-based strategies to cancer patients undergoing chemotherapy while in clinic and outside of clinic for the management of acute psychological distress and chemotherapy-related side effects.
The Calm app has over 2 million paying users and 65 million downloads, and was named Apple's "App of the Year" in 2017.9,10 The Calm app was developed based on tenets of mindfulness and cognitive behavioral therapy, and provides its users with a range of mindfulness-based options to choose from, including meditations, Sleep Stories, and Soundscapes. In the proposed study, the investigators will investigate the use of Calm among a small sample of colorectal cancer patients (N=30; n=15 per group) who are beginning adjuvant chemotherapy within 12-weeks post-surgery as compared to a usual care control group to determine its effects on acute psychological distress within a single chemotherapy session as well as chemotherapy-related side effects.
STUDY OBJECTIVES
Objective 1: Investigate the effects of using a meditation app to reduce psychological distress (measured using the Distress Thermometer), across multiple chemotherapy sessions (n=15) among colorectal cancer patients as compared to usual control (n=15).
The primary hypothesis for this objective is that those using a meditation app will experience a reduction in psychological distress from beginning to end of each chemotherapy session as compared to usual care.
Objective 2: Investigate the effects of using a meditation app on chemotherapy toxicity and tolerability (measured using patient medical records; dose reduction/modification, dose delays, # of cycles completed, hospitalization, cytopenias, etc.), fatigue (measured using the Brief Fatigue Inventory), and quality of life (measured using the General Version of the Functional Assessment of Cancer and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) among colorectal cancer patients during a chemotherapy treatment cycle (i.e., two-three week cycle between the sessions) as compared to a usual care control group.
The primary hypothesis for this objective is that those using the meditation app will experience less severe chemotherapy toxicity, greater chemotherapy tolerability, less fatigue, and greater quality of life as compared to the usual care control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calm Meditation | Experimental | Behavioral: Calm Meditation Mobile AppParticipants 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 intervention | –The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Calm Meditation Mobile AppThe 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. | Behavioural | Calm Meditation |
Primary outcome
Change in Distress
Time frame: 6-month average change from baseline (beginning of chemotherapy treatment session) to post-treatment (end of chemotherapy treatment session)
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.
4 secondary outcomes
Chemotherapy toxicity and tolerability
Time frame: Post-intervention (month 6)
Change in Fatigue
Time frame: Change from baseline (week 0) to post-intervention (month 6)
Change in Cancer Treatment-Related Quality of Life
Time frame: Change from baseline (week 0) to post-intervention (month 6)
Change in Cancer Health-Related Quality of Life
Time frame: Change from baseline (week 0) to post-intervention (month 6)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ruben Mesa principal investigator
Mays Cancer Center at UT Health San Antonio MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calm Meditation Mobile App in people with Cancer Colorectal, run by The University of Texas Health Science Center at San Antonio 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 3 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: withdrawn, as of the sponsor's last update on 31 Mar 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Distress (time frame: 6-month average change from baseline (beginning of chemotherapy treatment session) to post-treatment (end of chemotherapy treatment session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022.