Clinical trial NCT05500391: Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring
Official title: Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stage I Testicular Seminoma
Stage I Testicular Nonseminomatous Germ Cell Tumor
Gastrointestinal Stromal Tumors
Ovarian Germ Cell Tumor
Adenocarcinoma, Clear Cell
Borderline Ovarian Tumor
Sex Cord-Stromal Tumor
Mucinous Adenocarcinoma of Ovary
Carcinoma, Small Cell
Carcinosarcoma, Ovarian
Serous Tumor of Ovary
Glioma
Neuroendocrine Tumors
Aggressive Fibromatosis of Abdominal Wall (Disorder)
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Canceropôle Nord Ouest
name: Groupement Interrégional de Recherche Clinique et d'Innovation
First posted: 2022-08-15
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

Detailed description: The primary objective of this study is to compare 2-year compliance with the personalized post-treatment surveillance plan between the two arms.

The secondary objectives are to compare between the two arms :

* Long-term compliance (5-year follow-up)
* Use of care
* Oncological events and their management
* Supportive care needs

The exploratory objectives are to :

* Evaluate the costs in terms of medical transportation
* Evaluate and compare patients' satisfaction and psychological well-being (in terms of anxiety/depression)
* Evaluate the homogeneity of the impact of the intervention according to covariates (gender, tumor pathology, occupational status, and center)
* Evaluate the reasons for recruitment failures

Eligibility criteria: Inclusion Criteria:

* Positive diagnosis (anatomopathology) of tumor within 12 months
* Patient 18 years of age or older
* Patient with one of the following conditions:

  1. Desmoid fibromatosis of the abdominal wall operated on or under active surveillance
  2. Stage I testicular seminoma (whether or not treated with carboplatin AUC7)
  3. Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy)
  4. Operated GIST with low risk of relapse
  5. Rare gynecological tumors (sex cord and stromal tumors; germ cell tumors of the ovary, clear cell adenocarcinoma, mucinous adenocarcinoma of the ovary, borderline tumors, small cell carcinoma, ovarian and uterine carcinosarcoma, low grade serous tumors), operated
  6. Low-grade glioma, operated
  7. Low-grade neuroendocrine tumor, treated by surgery alone
* Patient who has given consent to participate in the study

Exclusion Criteria:

* Contraindication to imaging tests required for the surveillance plan
* No telephone
* Patient under guardianship or curatorship

Primary outcomes:
measure: 2-year compliance to the customized surveillance plan
timeFrame: 2 years
Secondary outcomes:
measure: 5-year compliance to the customized surveillance plan
timeFrame: 5 years
measure: Drop-out rate
timeFrame: 5 years
measure: Description of the use of care
timeFrame: 5 years
measure: Occurrence and management of oncological events
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Support care needs identified
timeFrame: 2 years (early termination in case of relapse of the disease)
Other outcomes:
measure: Costs in terms of medical transport use
timeFrame: 5 years
measure: Salary mass mobilized from a hospital perspective in both arms
timeFrame: 5 years
measure: Patient satisfaction
timeFrame: 2 years
measure: Patient reported outcomes
timeFrame: 2 years
measure: Evaluation of the causes of recruitment failures
timeFrame: During the recruiting period (18 months)
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Caen
country: France
facility: Centre François Baclesse
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: PENEL Nicolas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kimman ML, Bloebaum MM, Dirksen CD, Houben RM, Lambin P, Boersma LJ. Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer. BMC Cancer. 2010 Apr 30;10:174. doi: 10.1186/1471-2407-10-174.
citation: Moloney J, Partridge C, Delanty S, Lloyd D, Nguyen MH. High efficacy and patient satisfaction with a nurse-led colorectal cancer surveillance programme with 10-year follow-up. ANZ J Surg. 2019 Oct;89(10):1286-1290. doi: 10.1111/ans.15333. Epub 2019 Jul 7.
citation: Martin E, Persaud S, Corr J, Casey R, Pillai R. Nurse-led active surveillance for prostate cancer is safe, effective and associated with high rates of patient satisfaction-results of an audit in the East of England. Ecancermedicalscience. 2018 Jul 25;12:854. doi: 10.3332/ecancer.2018.854. eCollection 2018.
citation: Keshava HB, Tan KS, Dycoco J, Huang J, Berkowitz A, Sumner D, Devigne A, Adusumilli P, Bains M, Bott M, Isbell J, Downey R, Molena D, Park B, Rocco G, Sihag S, Jones DR, Rusch VW. Long-term assessment of efficacy with a novel Thoracic Survivorship Program for patients with lung cancer. J Thorac Cardiovasc Surg. 2022 May;163(5):1645-1653.e4. doi: 10.1016/j.jtcvs.2021.11.026. Epub 2021 Nov 20.
citation: Ferrua M, Minvielle E, Fourcade A, Lalloue B, Sicotte C, Di Palma M, Mir O. How to Design a Remote Patient Monitoring System? A French Case Study. BMC Health Serv Res. 2020 May 19;20(1):434. doi: 10.1186/s12913-020-05293-4.