Trial document




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  DRKS00021064

Trial Description

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Title

The SOFIA study: a randomized controlled feasibility trial of an E-Health intervention for cancer patients under immunotherapy

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Trial Acronym

SOFIA

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URL of the Trial

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Brief Summary in Lay Language

Adverse advents (AEs) are common among patients receiving immunotherapies. Especially in the first three montsh after initiation of immune checkpoint blockers, AEs are frequently reported. In the most severe cases, immunotherapy has to be discontinued. Therefore the early detection of AEs is important to prevent further aggravation of AEs and the interruption of therapy.
The aim of this study is the development and evaluation of an E-health intervention for patients under immunotherapy (SOFIA). SOFIA consists of two components: SOFIA-monitoring and SOFIA-coaching. SOFIA-Monitoring is an online tool for patients to rate patient reported outcomes (PROs) between visits. The oncologist receives the PROs (also longitudinally) before the visit so that the trajectory of symptoms over time can be seen and can be used for discussion and symptom management. SOFIA-Coaching provides important information about cancer- and immunotherapy-specific topics and the counselling services of the NCT Heidelberg. Study outcomes are measures of quality of life, psychosocial symptoms, self-efficacy and the physician-patient-communication.

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Brief Summary in Scientific Language

Adverse advents (AEs) are common among patients receiving immunotherapies. Especially in the first three months after initiation of immune checkpoint blockers, AEs like immune-related skin toxicities, endocrinopathies, hepatotoxicities, gastrointestinal toxicities, pneumonitis and fatigue are frequently reported. In the most severe cases, immunotherapy has to be discontinued. Therefore the early detection of AEs is important to prevent further aggravation of AEs and the interruption of therapy. The aim of this prospective study is the evaluation of an E-health intervention for patients under immunotherapy (SOFIA). SOFIA consists of two components: SOFIA-monitoring and SOFIA-coaching. SOFIA-Monitoring is an online tool for patients to rate patient reported outcomes (PROs) between visits. SOFIA-Coaching provides important information about cancer- and immunotherapy-specific topics and the counselling services of the NCT Heidelberg.
We outline a patient-level two-arm randomized controlled trial that compares the intervention (SOFIA) to treatment as usual (TAU) for cancer patients aged > 18 ages, recruited from the National Centre of Tumour Diseases (NCT), Heidelberg, Germany. Study outcomes are measures of quality of life, psychosocial symptoms, self-efficacy, physician-patient-communication and medical process data.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00021064
  •   2020/03/12
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  •   yes
  •   Approved
  •   S-581/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   MSI high tumours
  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C63 -  Malignant neoplasm of other and unspecified male genital organs
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
  •   C81 -  Hodgkin lymphoma
  •   C43 -  Malignant melanoma of skin
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Interventions/Observational Groups

  •   SOFIA + Treatment as usual
  •   treatment as usual
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

HRQoL; assessed with the EORTC QLQ C30, Version 3; three measurement points: T0 (at the beginning of the intervention); T1 (at the end of the three months intervention phase); T2 (6 months after the beginning of the study).

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Secondary Outcome

PHQ9-D, GAD7; NCCN Distress-Barometer, CBI-B-D, SCNS-SF34-D, FAPI; evaluation of the treatment under using SOFIA-Monitoring by the physicians; three measurement points: T0 (at the beginning of the intervention); T1 (at the end of the three months intervention phase); T2 (6 months after the beginning of the study).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/04/01
  •   96
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

(1) a diagnosis of bladder, lung carcinoma or renal carcinoma, head and neck tumours, Hodgkin's lymphoma, malignant melanoma or MSI high tumours; (2) ECOG 0-1; (3) predicted life expectancy > 3 months; (4) ownership of an Internet-capable end device on which SOFIA can be processed (e.g., smartphone); (5) speak German as mother tongue or have a very good knowledge of the German language; (6) written informed consent.

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Exclusion Criteria

Exclusion criteria are: (1) participation in other clinical studies; (2) ECOG >1; (3) limited legal capacity or impairment thereof; (4) cognitive or physical impairments that make it difficult to process the online modules (e.g. impaired vision); (5) serious psychiatric or mental illness.

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Fosanis GmbH
    • Rosenthaler Straße 46/47
    • 10178  Berlin
    • Germany
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    • Klinik für Innere Medizin und Psychosomatik und Nationales Centrum für Tumorerkrankungen Heidelberg
    • Ms.  Dr. phil.  Christina  Sauer 
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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    • NCT Heidelberg
    • Ms.  Dr.  Christina  Sauer 
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • NCT Heidelberg
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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