Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy

NCT ID: NCT03013946

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-18
• Study Completion Date: 2024-01-16

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 or a combination of pembrolizumab + axitinib or avelumab + axitinib in first line therapy.

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 sunitinib or a combination of pembrolizumab + axitinib or avelumab + axitinib in first line therapy.

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

Conditions

Renal Cell Carcinoma, Metastatic; Renal Cell Cancer, Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Concomitant coaching

Intervention Type: BEHAVIORAL

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

Arm B (Control)

Re-activeTEAE management (SOC) Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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].

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Crolll Gmbh

OTHER

Sponsor Role: collaborator

AIO-Studien-gGmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Viktor Grünwald, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Essen

Locations

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, Bavaria, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, Germany

Universitätsklinikum Essen (AöR)

Essen, Nordrhein-Westphalen, Germany

Hämatologisch-Onkologische Praxis Stolberg

Stolberg, North Rhine-Westphalia, Germany

Krankenhaus Barmherzige Brüder Trier

Trier, Rhineland-Palatinate, Germany

Universitätsklinikum Magdeburg A.ö.R.

Magdeburg, Saxony-Anhalt, Germany

Urologische Arztpraxis Dr. Ralf Eckert

Wittenberg, Saxony-Anhalt, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Klinikum St. Marien Amberg

Amberg, , Germany

Onkologisches Versorgungszentrum

Berlin, , Germany

Vivantes Klinikum Neukölln

Berlin, , Germany

BAG Onkologische Gemeinschaftspraxis

Dresden, , Germany

Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange Krex Fachärzte für Innere Medizin Hämatologie und Internistische Onkologie

Dresden, , Germany

MVZ für Hämato/Onkologie Essen gGmbH

Essen, , Germany

MVZ Onkologische Kooperation Harz

Goslar, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Tagesklinik Landshut Hämatologie, Onkologie Palliativmedizin

Landshut, , Germany

Klinikum Nürnberg 5. Medizinische Klinik

Nuremberg, , Germany

Wissenschaftskontor Nord GmbH & Co KG

Rostock, , Germany

Onkologische Schwerpunktpraxis

Singen, , Germany

MVZ Kloster Paradiese GbR/Onkologiezentrum Soest

Soest, , Germany

Countries

Germany

Other Identifiers

2016-000399-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AIO-NZK-0115/ass

Identifier Type: -

Identifier Source: org_study_id