Design of the PROstate cancer follow-up care in Secondary and Primary hEalth Care study (PROSPEC): a randomized controlled trial to evaluate the effectiveness of primary care-based follow-up of localized prostate cancer survivors.
Aftercare
/ economics
Aged
Anxiety
/ diagnosis
Cancer Survivors
/ psychology
Continuity of Patient Care
Cost-Benefit Analysis
Equivalence Trials as Topic
Feasibility Studies
General Practitioners
/ economics
Guideline Adherence
/ economics
Humans
Kallikreins
/ blood
Male
Multicenter Studies as Topic
Netherlands
/ epidemiology
Practice Guidelines as Topic
Primary Health Care
/ economics
Professional Role
Program Evaluation
Prospective Studies
Prostate-Specific Antigen
/ blood
Prostatectomy
/ adverse effects
Prostatic Neoplasms
/ diagnosis
Quality of Life
Radiotherapy, Adjuvant
/ adverse effects
Randomized Controlled Trials as Topic
Secondary Care
/ economics
Follow-up
General practitioner
Primary care
Prostate cancer
Randomized controlled trial
Secondary care
Specialist
Survivorship
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
08 Jul 2020
08 Jul 2020
Historique:
received:
20
05
2020
accepted:
25
06
2020
entrez:
10
7
2020
pubmed:
10
7
2020
medline:
30
1
2021
Statut:
epublish
Résumé
In its 2006 report, From cancer patient to cancer survivor: lost in transition, the U.S. Institute of Medicine raised the need for a more coordinated and comprehensive care model for cancer survivors. Given the ever increasing number of cancer survivors, in general, and prostate cancer survivors, in particular, there is a need for a more sustainable model of follow-up care. Currently, patients who have completed primary treatment for localized prostate cancer are often included in a specialist-based follow-up care program. General practitioners already play a key role in providing continuous and comprehensive health care. Studies in breast and colorectal cancer suggest that general practitioners could also consider to provide survivorship care in prostate cancer. However, empirical data are needed to determine whether follow-up care of localized prostate cancer survivors by the general practitioner is a feasible alternative. This multicenter, randomized, non-inferiority study will compare specialist-based (usual care) versus general practitioner-based (intervention) follow-up care of prostate cancer survivors who have completed primary treatment (prostatectomy or radiotherapy) for localized prostate cancer. Patients are being recruited from hospitals in the Netherlands, and randomly (1:1) allocated to specialist-based (N = 195) or general practitioner-based (N = 195) follow-up care. This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness. The outcome measures will be assessed at randomization (≤6 months after treatment), and 12, 18, and 24 months after treatment. This multicenter, prospective, randomized study will provide empirical evidence regarding the (cost-) effectiveness of specialist-based follow-up care compared to general practitioner-based follow-up care for localized prostate cancer survivors. Netherlands Trial Registry, Trial NL7068 (NTR7266). Prospectively registered on 11 June 2018.
Sections du résumé
BACKGROUND
BACKGROUND
In its 2006 report, From cancer patient to cancer survivor: lost in transition, the U.S. Institute of Medicine raised the need for a more coordinated and comprehensive care model for cancer survivors. Given the ever increasing number of cancer survivors, in general, and prostate cancer survivors, in particular, there is a need for a more sustainable model of follow-up care. Currently, patients who have completed primary treatment for localized prostate cancer are often included in a specialist-based follow-up care program. General practitioners already play a key role in providing continuous and comprehensive health care. Studies in breast and colorectal cancer suggest that general practitioners could also consider to provide survivorship care in prostate cancer. However, empirical data are needed to determine whether follow-up care of localized prostate cancer survivors by the general practitioner is a feasible alternative.
METHODS
METHODS
This multicenter, randomized, non-inferiority study will compare specialist-based (usual care) versus general practitioner-based (intervention) follow-up care of prostate cancer survivors who have completed primary treatment (prostatectomy or radiotherapy) for localized prostate cancer. Patients are being recruited from hospitals in the Netherlands, and randomly (1:1) allocated to specialist-based (N = 195) or general practitioner-based (N = 195) follow-up care. This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness. The outcome measures will be assessed at randomization (≤6 months after treatment), and 12, 18, and 24 months after treatment.
DISCUSSION
CONCLUSIONS
This multicenter, prospective, randomized study will provide empirical evidence regarding the (cost-) effectiveness of specialist-based follow-up care compared to general practitioner-based follow-up care for localized prostate cancer survivors.
TRIAL REGISTRATION
BACKGROUND
Netherlands Trial Registry, Trial NL7068 (NTR7266). Prospectively registered on 11 June 2018.
Identifiants
pubmed: 32641023
doi: 10.1186/s12885-020-07112-9
pii: 10.1186/s12885-020-07112-9
pmc: PMC7346492
doi:
Substances chimiques
KLK3 protein, human
EC 3.4.21.-
Kallikreins
EC 3.4.21.-
Prostate-Specific Antigen
EC 3.4.21.77
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
635Subventions
Organisme : KWF Kankerbestrijding
ID : 2015-7932
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