Systemic Therapy Consent Note (Chemotherapy/Immunotherapy)

Date/Time: [Date and time of consent discussion]

Location: [clinic / infusion center / inpatient unit / telehealth]

Author: [Clinician name and role]

Reason for Consent

[Reason consent is being obtained at this encounter, such as initiation of new regimen, re-consent after treatment gap or clinical change, regimen modification with new material risks, or addition of new agent] (Limit to one or two sentences.)

Participants

• Patient: [Patient name and identifiers per policy]
• Clinician conducting consent: [Name and credentials]
• Surrogate decision-maker: [Name, relationship, and basis of authority] (Include only if applicable.)
• Interpreter: [Interpreter identification; modality (in-person / video / phone); language] (Include only if applicable.)
• Family/support persons present: [Names and relationships] (Include only if present.)

Clinical Context

[Brief problem-oriented summary including cancer diagnosis with site and histology; stage or disease status (localized / metastatic / relapsed / refractory); line of therapy; relevant biomarkers influencing therapy selection] (Include performance status or comorbidities only if they materially affect the risk discussion. Do not duplicate a full history and physical.)

Proposed Therapy

Regimen: [Regimen name and component drugs] (For complex regimens, list drugs in administration order. Include integral supportive medications when relevant to the consent discussion.)

Route/Schedule: [Routes of administration (IV / SC / PO); cycle length and frequency]

Duration: [Planned number of cycles or treatment duration] (Include if known.)

Setting: [infusion center / inpatient / home oral therapy]

Planned start date: [Start date] (Include if available.)

Treatment Intent and Expected Benefits

Intent: [curative / adjuvant / neoadjuvant / disease control / palliative / symptom relief / survival prolongation / bridge to transplant or procedure]

Expected benefits: [Patient-appropriate description of anticipated benefits, such as tumor response, recurrence risk reduction, symptom control, or survival impact] (Use probabilistic language acknowledging uncertainty. If quantitative data were discussed, briefly note figures with source context.)

Material Risks and Toxicities

• Common/expected effects: [Common toxicities relevant to the specific agents, such as fatigue, nausea, myelosuppression, alopecia]
• Serious/potentially life-threatening risks: [Serious risks such as neutropenic fever, severe infection, bleeding, organ toxicity (cardiac / pulmonary / hepatic / renal), severe hypersensitivity or infusion reactions] (Include even if uncommon.)
• Long-term/late effects: [Delayed toxicities such as neuropathy, cardiomyopathy, infertility, secondary malignancy] (Include when relevant to the regimen.)
• Immunotherapy-specific risks: [Immune-related adverse events affecting skin, GI tract (colitis), liver (hepatitis), lungs (pneumonitis), endocrine organs (thyroiditis, hypophysitis, adrenal insufficiency, diabetes), kidneys (nephritis), nervous system, eyes, heart (myocarditis); note that events can occur during treatment or after discontinuation] (Include only if immunotherapy is proposed.)
• Oral therapy considerations: [Adherence requirements; drug-drug and drug-food interactions; safe handling and storage; criteria for holding or stopping therapy] (Include only if oral agents are prescribed.)
• When to seek urgent care: [Specific symptoms requiring same-day oncology contact or emergency evaluation, such as fever, severe diarrhea, new shortness of breath, chest pain, neurologic changes]

Alternatives Discussed

[Reasonable alternatives reviewed, such as alternative systemic regimens; radiation or surgery if clinically appropriate; clinical trial options; best supportive care or palliative-focused approach; observation or no treatment with expected disease course] (If patient asked about complementary or alternative approaches, document the question and counseling provided.)

Patient Questions and Shared Decision-Making

[Statement that questions were invited and addressed; summary of key questions asked and responses given; patient priorities or values influencing the decision] (Use brief patient quotes when they add clarity.)

Assessment of Capacity and Understanding

[Assessment of decision-making capacity; method used to assess understanding, such as patient verbalized understanding or teach-back; statement that consent is voluntary] (If capacity is limited, identify the surrogate decision-maker and basis of authority.)

Decision

Decision: [consents to proceed / declines treatment / defers decision]

[If declines: document informed refusal and plan for follow-up or alternative care. If defers: document what additional information is needed and when the decision will be revisited.] (Include only if patient declines or defers.)

Special Considerations

(Include only the subsections that apply to this patient.)

Pregnancy and Contraception: [Pregnancy status and testing if performed; contraception counseling during and after therapy; teratogenic risk discussion; breastfeeding counseling] (Include only for patients with reproductive potential.)

Fertility Preservation: [Infertility risk discussed; fertility preservation options offered or referral made; patient decision] (Include when infertility risk is relevant to patient age and treatment.)

High-Risk Comorbidities: [Baseline conditions that materially increase treatment risk; specific increased risk; mitigation strategy; specialist involvement] (Include when applicable.)

Clinical Trial: [Statement that research consent is separate from treatment consent; whether trial consent is completed and where filed] (Include only if therapy is part of a research protocol. Do not duplicate research consent content.)

Consent Documentation

Authorization method: [written consent / verbal consent per policy]

Written consent: [Date and time of signature; location of signed form (scanned location or e-consent system); witness signature if required; patient received copy confirmed] (Include if written consent obtained.)

Verbal consent: [Explicit statement that verbal consent was obtained per policy; reason signed form was not used] (Include if verbal consent obtained.)

Attestation

[Clinician attestation that consent discussion was personally performed]

[Signature, credentials, date/time]