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NCT05969860

At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved 11 months later.

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Record History

All 18 versions: 18 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jan 1, 2027 to Dec 1, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 129 words
    • Study completion pushed from Jan 1, 2027 to Mar 22, 2028
    • Start date: Aug 23, 2023 to Sep 21, 2023
    • Secondary endpoints: details revised at 8 of 9 entries
  2. Eligibility criteria revisedv17
  3. Eligibility criteria expanded, about 25 wordsv16
  4. Eligibility criteria expanded, about 52 words
    • Enrollment target: 200 to 220
    v15
  5. Primary and study completion dates: Dec 31, 2025 to Jan 1, 2027v14
Show 12 earlier versionsHide 12 earlier versions
  1. Eligibility criteria expanded, about 193 words
    • Study description expanded, about 30 words
    v13
  2. Primary and study completion dates: Jun 14, 2025 to Dec 31, 2025v12
  3. Study sites: 1 to 2
    • Primary and study completion dates: Jan 1, 2025 to Jun 14, 2025
    v11
  4. Eligibility criteria shortened, about 2 words
    • Study description shortened, about 15 words
    • Site contact updated
    v10
  5. Eligibility criteria expanded, about 28 wordsv9
  6. Eligibility criteria expanded, about 134 wordsv8
  7. Eligibility criteria expanded, about 34 words
    • Primary and study completion dates: Aug 23, 2024 to Jan 1, 2025
    v7
  8. Study description expanded, about 3 wordsv6
  9. Primary and study completion dates: Jan 1, 2024 to Aug 23, 2024
    • Eligibility criteria expanded, about 19 words
    v5
  10. Eligibility criteria shortened, about 33 wordsv4
  11. Primary and study completion dates: Jan 2024 to Jan 1, 2024
    • Study title shortened, about 4 words
    v3
  12. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2023 to Aug 23, 2023
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Mean patient-reported rating of Cancer Connected Access and Remote Expertise
Timeframe: At 8 weeks

Secondary (9)

Patient-preferred treatment location
Patient level of comfort with receiving infusions at home
Patient-reported worthwhileness
Patient-reported function
Patient-reported symptoms
Show 4 moreShow less
Patient-reported side effect impact
Incidence of adverse events
Emergency room visits and hospitalizations
Overall survival

Arms and interventions

Arm A (at-home treatment)Experimental

Patients continue receiving their SOC treatment regimen at home for approximately 24 weeks in the absence of disease progression or unacceptable toxicity. This includes drug administrations, injections/infusions and routine clinical laboratory tests in the home from the HHNP, overseen by Mayo Clinic's home health program CCBW Command Center. Patients are also provided biometric devices for health monitoring vital signs, as well as a computer tablet for video visits with the Mayo Clinic care team.

Arm B (clinic & at-home treatment)Experimental

Patients continue receiving their SOC treatment regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC treatment regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.

Procedures: Clinical Encounter

Other: Home Health Encounter, Quality-of-Life Assessment, Questionnaire Administration

Sites

2 sites in 1 country