NCT07711080

Brief Summary

This study is a longitudinal observational study that will investigate the feasibility of using mobile devices for the assessment of HRQoL and physical activity in adult cancer patients undergoing treatment. Patients will complete a set of patient reported outcome measures (PROMs), and wear a smartwatch (min. 10 hours per day for one week), at baseline, and at weeks 4, 8 and 12 after treatment start.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started Sep 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

May 13, 2026

Last Update Submit

July 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessing the general feasibility of implementing mobile devices for the assessment of HRQoL and PA over a period of 12 weeks in cancer patients undergoing treatment, identifying its major human and operational factors

    General feasibility index (GFI)

    baseline assessment week, week 4, week 8, week 12 and overall

Secondary Outcomes (3)

  • To assess the compliance with the Patient Reported Outcome remote assessment

    baseline and weeks 4, 8 and 12

  • To assess the compliance with the physical activity remote assessment

    baseline assessment week, week 4, week 8, week 12 and overall

  • To assess the patients' user experience related to the Patient Reported Outcome and physical activity remote assessment

    Within 1 month after Week 12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult cancer patients prior to the start of a new treatment without restrictions related to gender, cancer site or cancer stage.

You may qualify if:

  • Diagnosis of cancer
  • Age≥18
  • Starting a first or new anticancer treatment within one month following enrolment
  • Literacy in the target language
  • Ability to understand and fill out questionnaires
  • Ability to operate a smartphone
  • In possession of a smartphone allowing for an internet connection and willing to use this device to submit data
  • Written informed consent
  • Life expectancy\>3 months

You may not qualify if:

  • Exclusively receiving palliative care
  • Start of cancer-related treatment \< 1 week from time of screening
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before enrolment in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2026

First Posted

July 17, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

July 17, 2026

Record last verified: 2026-07