NCT04331678

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2021

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

March 31, 2020

Last Update Submit

December 15, 2023

Conditions

Chemotherapy Effect

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Caregiver's Burden

    Baseline, Three months

  • Caregiver's Disruptiveness

    Baseline, Three months

Study Arms (2)

Usual Care

NO INTERVENTION

Participants will be complete survey at enrollment and then again in 3 months.

Active

ACTIVE COMPARATOR

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

Interventions

Comparator AppBEHAVIORAL

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.

Active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to communicate in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

West Cancer Center

Southaven, Mississippi, 38671, United States

Location

West Cancer Center

Germantown, Tennessee, 38138, United States

Location

West Cancer Center

Memphis, Tennessee, 38104, United States

Location

Related Publications (1)

  • Graetz I, Hu X, Curry AN, Robles A, Vidal GA, Schwartzberg LS. Mobile application to support oncology patients during treatment on patient outcomes: Evidence from a randomized controlled trial. Cancer Med. 2023 Mar;12(5):6190-6199. doi: 10.1002/cam4.5351. Epub 2022 Oct 18.

    PMID: 36258654DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 2, 2020

Study Start

March 12, 2020

Primary Completion

October 24, 2021

Study Completion

October 24, 2021

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(3)