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

Chemotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331678
• Other study ID #: 2018-002b
• Status: Completed
• Phase: N/A
• Start date: March 12, 2020
• Est. completion date: October 24, 2021

Study information

• Verified date: December 2023
• Source: West Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: October 24, 2021
• Est. primary completion date: October 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy Effect

Intervention

Behavioral:
• Comparator App
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.

Locations

Country	Name	City	State
United States	West Cancer Center	Germantown	Tennessee
United States	West Cancer Center	Memphis	Tennessee
United States	West Cancer Center	Southaven	Mississippi

Sponsors (3)

Lead Sponsor	Collaborator
West Cancer Center	Emory University, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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