NCT05881070

Brief Summary

The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable cancer

Status
unknown

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

May 8, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

May 8, 2023

Last Update Submit

May 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patient's Quality of life

    The patient's quality of life will be assessed before (T0) and after intervention (T1). The measurement will use EORTC. The score will range from 0-100, where higher score reflects a better quality of life.

    Four weeks

  • Patient's Self-efficacy

    The patients self-efficacy will be measured pre and post intervention. The measurement will use the Self-Efficacy for Managing Chronic Disease Scale. The scale has been widely used in cancer setting. Respondents will rate their confidence to perform six self-management behaviours (1 = 'not at all confident' to 10 = 'totally confident'). A mean score is calculated (range 1 to 10). A high score indicates high self-efficacy.

    four weeks

Study Arms (1)

Mobile health self-management

EXPERIMENTAL
Behavioral: Mobile-health self management

Interventions

Mobile-health self management

Mobile health self-management

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients diagnosed with cancer
  • patients who use smart phone

You may not qualify if:

  • patients with cancer with comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 30, 2023

Study Start

June 15, 2023

Primary Completion

August 31, 2023

Study Completion

September 30, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05