Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04345952 |
Other study ID # |
CTMS# 20-0117 |
Secondary ID |
HSC20200636H |
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 2022 |
Est. completion date |
December 2023 |
Study information
Verified date |
December 2021 |
Source |
The University of Texas Health Science Center at San Antonio |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.