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Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib (PREPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03013946
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : January 28, 2020
Information provided by (Responsible Party):

Brief Summary:
The primary objective of the trial is to determine the effect of a 24-week concomitant coaching on patient reported outcomes of patients receiving standard treatment for mRCC with sunitinib.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma, Metastatic Renal Cell Cancer, Recurrent Behavioral: Concomitant coaching Phase 3

Detailed Description:

The goal of our study is to define the benefit of proactive coaching in mRCC, when compared to a reactive approach, which is considered the standard of care.

Patients in the Coaching Arm A will be trained continuously at personal interactions of coach and patient (Face-to Face meetings as well as telephone contacts). The patient is educated on nature and severity of treatment emergent Adverse events (TEAE) of the Sunitinib-Therapy.

Quality of Life (QoL) is assessed during sunitinib treatment in both arms (Arm A Coaching and Arm B non Coaching).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase III Study Testing the Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic Renal Cell Carcinoma Treated With Sunitinib
Study Start Date : January 2017
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : May 2023

Arm Intervention/treatment
Experimental: Arm A (Coaching)
Concomitant coaching (24 weeks) Pro-active TEAE (Treatment emergent adverse events) management Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15
Behavioral: Concomitant coaching

The corner stones of the pro-active coaching are as follows:

  • Patient education:

    • Information on nature and severity of treatment emergent AEs
    • information about remedies for TEAEs
    • propagation and explanation of tests and treatment decisions
    • Patient instruction on self-care and preventive measures
  • Preemptive AE treatment strategies
  • Supervision of reported ADR severity, ADR mitigation strategies according to recommendations of the PREPARE protocol and cancer treatment modification by treating physician in close collaboration with the coach

No Intervention: Arm B (Control)
Re-activeTEAE management (SOC) Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15

Primary Outcome Measures :
  1. QoL assessment during sunitinib treatment: questionnaire [ Time Frame: 24 weeks from randomization ]
    Rate of responders to concomitant coaching assessed by the (Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI)) FKSI-15 questionnaire.

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) according to RECIST 1.1 criteria [ Time Frame: up to one year from randomization ]
    Objective Response Rate (ORR) according to RECIST 1.1 criteria

  2. Overall Survival (OS) [ Time Frame: up to 36 months from randomization ]
    Overall Survival (OS)

  3. progression-free survival (PFS) [ Time Frame: up to 36 months from randomization ]
    progression-free survival (PFS)

  4. Duration of treatment (coaching and cancer treatment) [ Time Frame: Coaching: up to 24 weeks from randomization / cancer treatment: up to 36 months from randomization ]
    Duration of treatment (coaching and cancer treatment)

  5. dose density of sunitinib [ Time Frame: 24 weeks from randomization ]
    dose density of sunitinib

  6. Rate of patients receiving treatment beyond progression [ Time Frame: up to 36 months from randomization ]
    Rate of patients receiving treatment beyond progression

  7. Further cancer treatment [ Time Frame: up to 36 months ]
    Further cancer treatment

  8. Time to first subsequent therapy (TFST) [ Time Frame: up to 36 months ]
    Time to first subsequent therapy (TFST)

  9. Patient adherence / treatment discontinuation due to Adverse drug reactions (ADRs) / Serious adverse events (SAEs): [ Time Frame: 24 weeks from randomization ]
    % of patients with treatment discontinuation due to specific ADRs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)

  10. Treatment Emergent Adverse Events according to CTC 4.03: [ Time Frame: 24 weeks from randomization ]
    • Frequency/incidence, severity, percentage reduction, time-to-event of ADRs, AEs and specific TEAEs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)
    • change of grade 3/4 ADRs

  11. Assessment of comorbidities [ Time Frame: at inclusion ]
    Charlson Comorbidity Index (CCI)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
  2. Age ≥ 18 years at time of study entry
  3. Advanced or metastatic renal cell carcinoma, not amendable to surgery with curative intent, rendering the patient eligible for Tyrosin Kinase Inhibitor (TKI) treatment with sunitinib
  4. Intended first-line treatment with sunitinib
  5. Documented progressive disease within 6 months prior to study inclusion
  6. Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as well as non-measurable disease are eligible.
  7. Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and patient recovered from toxic effects.
  8. Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
  9. Subject is willing to receive additional concomitant coaching and able to comply with the QoL/PRO (patient-reported outcome) assessments specified in the protocol for the duration of the study including scheduled visits, examinations and follow up.

Exclusion Criteria:

  1. Any other anti-cancer treatment aside of sunitinib for mRCC (except palliative radiotherapy)
  2. Previous malignancy (other than mRCC) which either progresses or requires active treatment.

    Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial bladder tumor [Ta, Tis and T1].

  3. CNS metastases, unless local therapy has been completed for at least 3 month and patient does not require the use of steroids.
  4. Chronic liver disease with Child-Pugh B or C score
  5. Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year)
  6. Any condition that, in the opinion of the investigator, would interfere with evaluation of the concomitant coaching or QoL assessments or interpretation of patient safety or study results
  7. Participation in another clinical study with an investigational product during the last 30 days before inclusion
  8. Any previous treatment with a tyrosine kinase inhibitor for metastatic disease. Adjuvant or neoadjuvant therapy for localized disease is permitted, provided that relapse occurred at least 6 months after last exposure
  9. Previous enrollment or randomization in the present study (does not include screening failure).
  10. Involvement in the planning and/or conduct of the study (applies to both Pfizer staff and/or staff of sponsor and study site)
  11. Patient who might be affiliated or otherwise dependent on the sponsor, site or the investigator
  12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG].
  13. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03013946

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Contact: Aysun Karatas, Dr. +49 30 8145 344 ext 31
Contact: Markus Detzner +49 30 8145344 ext 52

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Sponsors and Collaborators
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Principal Investigator: Viktor Grünwald, Prof. Dr. Universitätsklinikum Essen
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Responsible Party: AIO-Studien-gGmbH Identifier: NCT03013946    
Other Study ID Numbers: AIO-NZK-0115/ass
2016-000399-28 ( EudraCT Number )
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases