NCT05584540

Brief Summary

This research is being done to find out if using a smartphone app as digital treatment to reduce Cancer Related Fatigue is feasible and easy to use. This research study is evaluating a smartphone application named the "Untire" app. The Untire app was designed as a digital treatment plan for people experiencing Cancer Related Fatigue (CRF).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 14, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
2.3 years until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

October 14, 2022

Last Update Submit

March 10, 2025

Conditions

Colorectal CancerFatigue

Keywords

Colorectal CancerFatigue

Outcome Measures

Primary Outcomes (1)

  • Enrollment Rate

    Primary outcome is feasibility. Feasibility will be described as the number and percentage of enrolled patients that used the app more than once.

    3 months

Secondary Outcomes (1)

  • CSQ-I Score

    3 months

Other Outcomes (1)

  • The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Ratings

    Baseline and at 4, 8, and 12 weeks.

Study Arms (1)

UNTIRE App

EXPERIMENTAL

At baseline meeting participants will answer questionnaires and be introduced and instructed on self-managed use of Untire app treatment program. Participants will then have check in meetings assessing app usage and progress on weeks 4, 8 and 12 post baseline, then a final check-in 6 months post baseline.

Behavioral: UNTIRE App

Interventions

UNTIRE AppBEHAVIORAL

Digital therapeutic application

UNTIRE App

Eligibility Criteria

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

You may qualify if:

  • \>/= 18 years of age
  • Owns a smart phone or Ipad
  • Diagnosis of Metastatic Colorectal Cancer, adenocarcinoma
  • Actively undergoing treatment for Metastatic disease
  • Speak and read English at a 6th grade level or higher
  • A score of 1 or greater on the PRO CTACE DFCI fatigue (questions 53a or 53b)

You may not qualify if:

  • Patients in Surveillance
  • Patients receiving end of life care
  • Patients taking dexamethasone other than for the control of nausea
  • Patients taking methylphenidate (Ritalin) for the treatment of CRF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nina N Grenon, DNP, AOCN

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2022

First Posted

October 18, 2022

Study Start

January 30, 2025

Primary Completion

December 30, 2025

Study Completion

January 30, 2026

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US(1)