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

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

Detailed Description
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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.

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

Conditions
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Chemotherapy Effect

Intervention / Treatment
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* Behavioral: Comparator App


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants will be complete survey at enrollment and then again in 3 months. | |
| Active Comparator: Active<br>Participants in the App group will receive usual care and complete survey at enrollment and then again in 3 months. In addition, they will be asked to download the study app to their mobile device and use it at least once per week during the 3-month study period. | Behavioral: Comparator App<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short-Form Health Survey (SF-12) | 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. | Baseline, Three months | 
| Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score | 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. | Baseline, Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver's Burden | 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. | Baseline, Three months | 
| Caregiver's Disruptiveness | 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. | Baseline, Three months |