Chemotherapy Consent/Assent Discussion Note (Pediatric Oncology)

Date/Time of Discussion: [Date and time]

Setting: [inpatient / clinic / infusion center / telehealth]

Participants: [Patient; parent(s)/guardian(s) with relationship; care team members present]

Interpreter: [Interpreter used: language, modality / Not used / Not applicable]

Consent Provided By: [Name, relationship, legal authority]

Clinical Context and Treatment Plan

[Clinical context and treatment summary] (3–5 sentences covering: working diagnosis with relevant qualifiers such as stage, risk group, or relapse/refractory status; treatment intent [curative / disease control / symptom palliation]; regimen or protocol name and whether on or off trial; route(s) and general schedule/duration; urgency of initiation; key supportive requirements anticipated such as central line, transfusions, hospitalizations, or sedation for procedures.)

Consent Discussion

[Narrative summary of discussion] (Document that the clinician explained the proposed treatment in understandable terms, that the decision was voluntary, and that questions were invited and answered. Emphasize patient/family-specific concerns addressed.)

Benefits/Goals: [Expected benefits aligned with treatment intent, acknowledging uncertainty as appropriate]

Material Risks Discussed: (Document categories actually discussed; highlight regimen-specific toxicities.)

• Common burdens: [Nausea, fatigue, alopecia, mucositis, etc. as discussed]
• Hematologic/infection risk: [Myelosuppression, transfusion needs, infection risk; fever/ED return triggers reviewed]
• Organ toxicities: [Cardiac / renal / hepatic / neurologic / ototoxicity / other as applicable to agents]
• Infusion/hypersensitivity reactions: [Risk and monitoring reviewed]

Long-Term/Late Effects: [Late effects reviewed as relevant: fertility/endocrine, cardiac, neurocognitive, secondary malignancy] (Note that late-effects counseling is ongoing.)

Alternatives Discussed: [Alternatives reviewed including different regimen, clinical trial, delayed start, supportive/palliative care only, second opinion, and no treatment with expected consequences]

Comprehension: [Evidence of understanding: teach-back, guardian summary, questions asked and answered; note any persistent concerns or need for additional support]

Fertility and Reproductive Health Counseling

[Fertility counseling summary] (Document that fertility risk was discussed in developmentally appropriate terms.)

• Pubertal/reproductive status: [Prepubertal / peripubertal / postpubertal; pregnancy potential if relevant]
• Preservation options reviewed: [Options discussed with feasibility, timing constraints]
• Family/patient decision: [Interested / uncertain / declined]
• Referral: [Offered / placed / deferred] (Include timing relative to chemotherapy start.)
• Pregnancy testing/teratogenic counseling: [Status and contraception recommendations if applicable]
• If deferred: [Reason and specific plan to revisit] (Required if counseling not completed.)

Assent Discussion

[Summary of developmentally appropriate conversation with patient] (Describe what the child/adolescent was told; include brief direct quote if helpful.)

• Patient understanding: [Clinician assessment of comprehension]
• Voluntariness: [Absence of coercion noted]
• Assent status: [Assented / neutral / objected / not sought]
• If dissented: [Concerns expressed; supportive steps taken; rationale if treatment proceeds; ethics consultation considered]
• If not sought: [Reason and plan to engage when feasible]

Consent Outcome and Documentation

• Decision: [Proceed / defer / decline]
• Consent type: [Written consent signed / verbal consent per institutional policy]
• Signed by: [Name, relationship, date/time]
• Document location: [Scanned to EHR / e-consent platform / paper chart]
• Education materials provided: [Titles/types provided; note language if non-English]
• Next steps: [Immediate plan: admission, line placement, first dose timing, fertility referral, follow-up for deferred items]

(If any required element was not completed—fertility counseling, assent—explicitly state the reason and plan to address. Do not leave gaps without explanation.)