Calm for Cancer Patients Receiving Chemotherapy

NCT04345952 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

  • Cancer Colorectal

Interventions

BEHAVIORAL

Calm Meditation Mobile App

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.

Sponsors & Collaborators

  • Arizona State University

    collaborator OTHER
  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Ruben Mesa · Mays Cancer Center at UT Health San Antonio MD Anderson

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2023-02-28
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04345952 on ClinicalTrials.gov