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Completed

NCT Number: NCT02460822

Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management

This research project addresses critical gaps in cancer symptom management through the creation of a mobile chemotherapy symptom management application. This application will assess for the presence and severity of common chemotherapy side-effects and provide personally tailored symptom-related video and narratives to enhance self-management of cancer and treatment-related symptoms. This study will examine patient acceptance and use of this mHealth application (called MyChemoCare) in a prospective trial of cancer patients (n=60) who are receiving chemotherapy for colorectal cancer at the University of Michigan Comprehensive Cancer Center.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with colon or rectal cancer
  • Expected to live at least 6 months
  • Initiating chemotherapy for the first time in their treatment history
  • Physically and mentally able to participate
  • Able to read English
  • Willing and able to sign informed consent

Exclusion criteria

  • A treatment plan that does not include cytotoxic chemotherapy for colon or rectal cancer
  • A medical history that includes cancer with the exception of in situ cancers of the cervix and basal cell cancers of the skin
  • A current diagnosis that includes multiple cancers (this does not exclude metastatic disease)
  • Received prior cytotoxic chemotherapy for any reason
  • A diagnosed psychiatric disorder

Treatment and study plan

MyChemoCare iPad application

Device

Primary outcomes

  1. Patient Retention and Engagement With the MyChemoCare Application

    Time frame: 8 weeks post-enrollment

    Patient retention is defined as the number of patients who completed the 8-week study through the final evaluation. Engagement with the MyChemoCare application was measured as number of patients who checked in at least once per week of the study.

  2. Patient Satisfaction and Usability of the MyChemoCare Application

    Time frame: 8 weeks post enrollment

    The investigators will use a 9-item survey developed by Dr. An to assess patients' experiences using the MyChemoCare app.

    This result is the mean of the the survey items (with opposite items reversed). The scale was scored from 0 = Strongly disagree to 6 = Strongly agree.

Secondary outcomes

  1. Physician Use of the Study Feedback Mechanism

    Time frame: 8 weeks post-enrollment

    The investigators will assess for how many of the enrolled patients the physicians use the feedback from the app to assist in clinical care of the patients. This includes following up about distressing symptoms and using information provided by the patient during regular clinical visits.

  2. Increased Mastery of Cancer and Chemotherapy Symptoms

    Time frame: 8 weeks post enrollment

    The investigators will use the Cancer Care Mastery Scale to assess patients' feelings of control over their cancer care. This scale is based on the Mastery Scale developed by Pearlin and Schooler, designed to capture the sense of control a patient feels over their cancer care. This is a 7-item scale where users are asked to respond to statements by choosing and answer from the following: Strongly disagree, Disagree, Neither agree or disagree, Agree, Strongly agree. Mastery scores were computed by taking the numeric mean of the items (1-5), with negatively worded items reversed.

    The number presented here is the number of patients whose mastery score improved between baseline and the end of the 8-week program. Because this is a small pilot study, we measure ANY improvement with no threshold specified.

  3. Symptom Burden Reduction

    Time frame: 8 weeks post enrollment

    The investigators will use the MD Anderson Symptom Inventory (MDASI) to describe patient experiences in 8 core symptom areas (pain, fatigue, nausea, disturbed sleep, distress, lack of appetite, weakness, and diarrhea). For each area, patients are asked to rank their symptoms on a scale from 0 (Not present) to 10 (As bad as you can imagine). The overall score is the mean across all 8 items.

    The number reported here is the count of patients with a reduction in symptom burden between baseline and 8-week follow up. Because this is a small pilot study, we measure ANY reduction with no threshold specified.

  4. Improved Quality of Life

    Time frame: Baseline and 8 weeks post enrollment

    The investigators will use the FACT-G survey to assess four dimensions of patients health (physical, functional, social and emotional). For each of the dimensions, patients are given a series of statements about specific elements of well being and asked to rank them on the following scale: Not at all, a little bit, Somewhat, Quite a bit, or Very much. These items are given numeric values of 0-4, with negatively worded statements reverse coded. Within each of the four dimensions of health, average scores are calculated, and then an overall sum is derived. Total well-being ranges from 0 (Complete lack of well being) to 16 (Completely well).

    The number presented is the count of participants for whom the overall FACT-G score increased between baseline and 8-week followup. Because this is a small pilot study, we measure ANY increase with no threshold specified.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • McKesson Foundation

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2015
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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