NCT05227599

Brief Summary

The purpose of this study is to determine the feasibility and acceptability of tracking survivors' and their caregivers, stressors, affect, and symptoms using an electronic diary method, in the time period surrounding their routine check- up with their oncologist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

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 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2022

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

January 26, 2022

Last Update Submit

September 10, 2023

Conditions

Survivorship

Outcome Measures

Primary Outcomes (1)

  • Online survey questionnaire

    participants will complete a brief online survey every morning and evening within 1 hour of waking and 1 hour of going to sleep

    21 days

Study Arms (1)

Daily Diary Method Cohort

OTHER

Participants will be asked to complete a self-report questionnaire that has been validated to assess daily affect. There are 5 items assessing positive affect (joyful, cheerful, happy, lively, proud) and 5 items assessing negative affect (miserable, mad, afraid, scared sad). The respondent is asked to rate these 10 different feelings on a 5-point Likert scale from 1, "not much or not at all" to 5, "a lot."

Other: Online survey questionnaire

Interventions

Online survey questionnaireOTHER

Participants will complete a brief online survey every morning and evening within 1 hour of waking and 1 hour of going to sleep. The surveys will be a combination of measures used to assess affect, stress, and symptoms

Daily Diary Method Cohort

Eligibility Criteria

Age11 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old
  • previously received a pediatric cancer diagnosis and treatment for such
  • completed cancer treatment \<5 years ago, in remission
  • Own a smart phone or tablet
  • are English proficient

You may not qualify if:

  • no cognitive, motor, or sensory deficits that could preclude completion of study measures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

San Francisco, California, 94305, United States

Location

Study Officials

  • Claudia Mueller, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 7, 2022

Study Start

March 1, 2021

Primary Completion

March 24, 2022

Study Completion

March 24, 2022

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

US(1)