To determine the feasibility of at-home monitoring patients with oesophageal cancer during chemoradiotherapy.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At least 80% of participants complete at least 80% of predefined at home
measurements.
Secondary outcome
n.a.
Background summary
Chemoradiotherapy is part of standard treatment for patients with locally
advanced oesophageal cancer. Some patients with oesophageal cancer treated with
chemoradiotherapy do not complete treatment due to toxicity, or face
complications after treatment. Therefore, there is a need for better tools for
assessing patients' fitness for chemoradiotherapy and to pick up early signals
of deteriorating overall physical condition and complications during and after
treatment to timely implement supportive care measures. Tools enabling
monitoring physical activity, vital parameters and creatinine concentration in
the blood at home are available but have not yet been implemented in patients
undergoing chemoradiotherapy for oesophageal cancer. The feasibility and added
value remain unknown.
Study objective
To determine the feasibility of at-home monitoring patients with oesophageal
cancer during chemoradiotherapy.
Study design
Observational study.
Study burden and risks
Participants will collect biometric and quality of life data for ~10 weeks at
home. Continuous step counting will be used to register physical activity.
Participants will be asked to measure their blood pressure, heart rate, oxygen
saturation level, pain level and temperature each morning, and weight 3 times a
week. These measurements consume little time and are not harmful. Once a week
they will perform a finger stick test themselves to determine creatinine
concentration in the blood. This measurement is a small burden to patients as
the finger prick can cause pain. There is a small risk of an infection at the
finger prick site. In addition, patients fill in three questionnaires at four
time points which will take approximately 20 minutes to complete. We do not
foresee reasonable risks of these diagnostic procedures for the participants.
For the individual participant, a potential benefit may be that relevant
changes in physical condition are noticed earlier, potentially resulting in
timely implementation of supportive measures. However, it is also possible that
patients must make an extra visit to the hospital as a result of abnormal
measurements, for example in case of tachycardia.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 18 at the time of signing informed consent.
2. Histologically proven adenocarcinoma, squamous cell carcinoma or mixed type
of the oesophagus or gastro-oesophageal junction.
3. Indication for definitive or neoadjuvant CRT, with chemotherapy that
consists of weekly carboplatin/paclitaxel.
4. Written, informed consent.
5. Ability to comply with all protocol required actions (at home measurements
are done individually by the participant him- or herself).
Exclusion criteria
1. Altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent or the carrying out of the
measurements at home.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83242.042.22 |
| Other | volgt |