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Completed

NCT Number: NCT04331678

Evaluation of a Mobile App to Promote Social Support for Oncology Patients

Our study will evaluate patient and caregiver use of a new mobile application (app) to support patients undergoing chemotherapy treatment for cancer.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Cancer Center, Southaven, Mississippi, United States

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About this study

The app is designed to be used by the patient and members of their support network. It provides wide-ranging functionality, including: reminders for appointments and tasks, the ability to track health measures (fitness, emotion, pain, sleep), archive health related documents, maintain notes and recordings from visits, social networking functions to connect with family and friends to coordinate support activities and share news, and educational resources. We will randomize 230 patients initiating chemotherapy cancer treatment and up to one caregiver to the App group (asked to use the app once or more per week) or the Usual Care group, and evaluate the 3-month efficacy of app use on key outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years of age
  • Patients must have a confirmed diagnosis of cancer and be prior to or within one month of initiating chemotherapy or immunotherapy
  • Have a valid email address
  • Have a smart mobile device (Android or iOS) with a data plan
  • Willing to download and use the study app

Exclusion criteria

  • Unable to communicate in English.

Treatment and study plan

Comparator App

Behavioral

Participants will download and agree to use the study app at least once per week during the 3-month intervention period.

The app allows participants to invite a network of friends and family to provide emotional and logistical support during their treatment.

Primary outcomes

  1. Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score

    Time frame: Baseline, Three months

    a. Investigators will measure the relative changes in functional status of cancer patients using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. FACT-G is a 27-item questionnaire asking participants to report the four primary QoL domains, including physical, social/family, emotional and functional well-being on a 5-point Likert scale where 0 = Not at all to 4 = Very much with higher scores representing better general QoL.

  2. Change in Short-Form Health Survey (SF-12)

    Time frame: Baseline, Three months

    a. Investigators will measure differences in quality of life between the two study arms with the SF-12 instrument. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.

Secondary outcomes

  1. Caregiver's Burden

    Time frame: Baseline, Three months

    Changes in the caregiver's burden assessed using the 10-item Caregiver Quality of Life - Cancer Scale (CQOLC) Burden Subscale, where higher scores indicate greater burden.

  2. Caregiver's Disruptiveness

    Time frame: Baseline, Three months

    Changes in the caregiver's disruptiveness of daily life will be assessed using the 7-item CQOLC Disruptiveness Subscale, where scores are calculated as described for burden, and higher scores indicate greater disruptiveness.

Sponsors and collaborators

Lead sponsor

West Cancer Center

Other

Collaborators

  • Emory University
  • Pfizer

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2020
Registry last updated
Dec 18, 2023

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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