ePRO diary template · OncologyUpdated October 9, 2026

Chemotherapy side effects diary: a symptom log for oncology trials

Participants on cancer treatment feel side effects between visits, and recall at the next appointment is poor. This generic diary lets them log common symptoms, how bad they were and what they did about them, on their own phone.

  • Daily phone diary, no app
  • Severity and interference
  • Fever and clinic contact captured

Free sandbox · No credit card · 21 CFR Part 11 aligned

Daily symptom diary · Cycle 2, Day 5

Subject 006-0011 · Demo study

Nausea today

NoneMildModerateSevere

Fatigue today

No fatigueWorst imaginable

Diarrhoea (number of loose stools)

3

Highest temperature today

37.4°C

Did you contact the clinic?

NoYes
Demo data. Not a diagnosis or a substitute for contacting the clinic

At a glance

  • A daily phone diary for the symptoms most common during chemotherapy and other systemic cancer treatment: nausea, vomiting, diarrhoea, constipation, fatigue, pain, mouth sores, rash, numbness and appetite.
  • Each symptom is a simple severity rating plus a few counts, such as vomiting episodes and loose stools, so the data can be tabulated by cycle day.
  • It is a generic diary, not the PRO-CTCAE. The NCI's PRO-CTCAE items have their own terms of use and are on a separate page: PRO-CTCAE eCRF template.
  • Participants also log temperature and whether they contacted the clinic, but a diary is not monitored in real time. Your consent and instructions must tell participants who to call for fever, severe vomiting or any urgent problem.
  • Counts and averages (for example days with grade 3-like nausea) are derived in analysis, since Capture's calculated fields are a fixed set of clinical derivations.

Why a diary

What gets lost without a daily symptom log

In most oncology trials toxicity is graded by clinicians at visits, often three weeks apart. A participant who vomited for two days in week one and felt fine by the visit will report "a bit queasy". Between cycles the worst days, their timing relative to the infusion, and what the participant did about them go unrecorded, even though they are what supportive-care trials, dose-modification rules and tolerability analyses depend on.

A phone diary gives each day its own timestamped record. It shows the nadir of symptoms by cycle day, how quickly they settle, and whether anti-emetics or other relief were used. It also gives clinicians something concrete to discuss at the visit. For a standardised, validated patient-reported toxicity measure, use the PRO-CTCAE; for quality of life, the EORTC QLQ-C30. This diary sits alongside them: a short daily log, not a replacement for either.

Choosing the symptom list

A list of ten symptoms is the limit for most people on a phone, every day. Choose symptoms that fit the regimen in your protocol (neuropathy for taxanes, hand-foot skin changes for some targeted agents, mouth sores for some chemotherapies) and let participants add one free-text symptom.

Severity scale

Use a four-step scale (none, mild, moderate, severe) with plain-language anchors, and tell participants it is their own rating. Do not call the options "grade 1 to 4": CTCAE grades are clinician assessments, and mixing them with self-ratings in the same dataset confuses analyses.

Safety is a separate process

A diary entry does not reach a clinician instantly. Put fever thresholds, emergency numbers and what to do in the diary header and the consent form, and record any resulting event on the adverse event eCRF. If a severe answer should prompt follow-up by site staff, add a custom-value edit check so it raises a query in their action list, and agree who reviews that list and how often.

Symptom diary completion · demo cohort

Diaries this week

41 of 48

Overdue today

5

Severe answers to review

3

Cycle 1 days 1-744/48
Cycle 1 days 8-1438/48
Cycle 2 days 1-741/48
Demo data

Template

Oncology side effect diary: field by field

FieldQuestion typeValuesWhy it is there
Cycle and dayPrefilled by schedulee.g. Cycle 2, day 5Aligns symptoms with treatment timing
NauseaSingle choiceNone, mild, moderate, severeMost common chemotherapy symptom
Vomiting episodesNumericCount in the last 24 hoursCounts are easier to tabulate than ratings
Loose stoolsNumericCount in the last 24 hoursDiarrhoea burden
ConstipationSingle choiceNone to severeOften follows anti-emetics
FatigueSliderNo fatigue to worst imaginableHighest-burden symptom in many regimens
PainLinear scale0 to 10See the pain diary for a fuller log
Mouth sores, rash, numbness, appetite lossSingle choice eachNone to severeRegimen-specific
Highest temperatureNumeric°C or °F, per protocolTriggers the fever instructions
Interference with usual activitiesSingle choiceNot at all to very muchImpact beyond the symptom itself
Medication taken for symptomsMultiple choice, textAnti-emetic, loperamide, otherSupportive care use
Contacted the clinicSingle choice, textYes/no, reasonRecords the action taken

Adapt the list to your regimen. The wording is generic and written for this template; it does not reproduce PRO-CTCAE or any other licensed item set.

Run it as ePRO

A two-minute diary on the participant's phone

Capture sends a secure link by email or SMS that opens in the phone browser, tied to the participant's record, with no app to install. The diary is scheduled as a daily task for the days the protocol needs, usually from day 1 of each cycle for 7 to 14 days.

  • Reminders when a task is due, the next day and before the window closes, with quiet hours respected.
  • Completion windows so entries describe the day they were made.
  • Overdue participants visible to site staff on the dashboard.
  • One export row per diary entry, with a data dictionary.
ePRO compliance reminders
1

When due

18:00

Your evening diary is open

2

Next day

18:00

Reminder: your diary is still open

3

Final notice

21:30

Last chance before the window closes

Quiet hours

22:00 to 08:00 in the participant's time zone

Stops

As soon as the task is completed

Walk through a cycle of entries

Build the diary from the field table, schedule it for days 1 to 14 and enter a week of demo symptoms in the free sandbox.

Build this diary free

Before go-live

Side effect diary setup checklist

Symptom list fits the regimen

No more than ten symptoms plus one free-text symptom.

Emergency instructions in the header

Fever threshold, phone number and what to do if the diary shows severe symptoms.

Review process agreed

Who looks at severe answers, how often, and where follow-up is recorded.

Relationship to PRO-CTCAE decided

Run both, or only one, and say why in the protocol; see the PRO-CTCAE template.

Schedule by cycle day

Tasks start at day 1 of each cycle with a completion window.

Consent mentions the diary

Participants know what is collected and that it is not monitored in real time.

FAQ

Questions about this template

Something not covered here? Ask us directly.

Is this the PRO-CTCAE?

No. It is a generic diary written for this template. The NCI's PRO-CTCAE has its own item library and terms of use, covered on a separate template page.

Are severe answers sent to a clinician immediately?

Not automatically. A custom-value edit check can raise a query in the site's action list, but a diary is not real-time monitoring. Give participants emergency instructions and agree a review routine.

How often should participants complete it?

Usually daily during the high-risk days after each treatment, for example days 1 to 14 of each cycle. Your protocol decides.

Can I add symptoms for my regimen?

Yes. Add or remove single-choice questions and allow one free-text symptom. Keep the list short enough for daily use on a phone.

Does Capture calculate symptom-free days?

No. Derived values such as days with moderate or severe symptoms are calculated in analysis from the exported entries.

Do participants need an app?

No. The diary opens in the phone browser from a secure link sent by email or SMS.

Is the template free?

Yes, in the free sandbox with the rest of the template library. You pay only when a study goes live.

Capture the days between visits

Build the symptom diary, schedule it by cycle day and test it on your phone. Free sandbox, no credit card.

Build this diary free