Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471452
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-03-05
Brief Title:
To Live Better After Breast Cancer Treatment
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
To Live Better After Breast Cancer Treatment - a Randomized Pilot Trial of a Supportive and Person-centered Care Intervention in Primary Healthcare
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The most common cancer among women in Sweden is breast cancer Advances in treatment have improved survival but these advances have come at a steep price since most treatments impose substantial morbidity and burden on patients and their families Furthermore many survivors from cancer have ongoing poor health and well-being and long-term rehabilitation and support should not be neglected to prevent recurrence and increase survival There are good reasons to believe that routine collection of relevant patient-reported symptoms facilitates person-centered care where the patient is a participatory member of the team This study aims to pilot-test a supportive and person-centered care intervention in primary healthcare for six months during the first year after primary treatment for breast cancer assisted by digital technology and compare it to standard care only The intervention consists of symptom reporting and management in an app in combination with health dialogues with a study-specific nurse at the Primary healthcare centre
Detailed Description:
The incidence rate of breast cancer has increased during the past decades and has surpassed lung cancer as the most frequently diagnosed type of cancer worldwide In Sweden it is the most common cancer among women and in 2021 8 616 women received a diagnosis the ten-year survival rate is over 87 The overall increase in survival rates can be explained by population-based mammography screening early detection and advancements in treatment The negative impact of treatment on patients quality of life QoL has been established as important to consider in the adjuvant treatment setting of operable breast cancer Furthermore several treatments are given over longer periods eg anti-hormonal treatments are prescribed for up to 10 years after a breast cancer diagnosis As the number of patients with breast cancer increases so does the demands on the healthcare services throughout the whole cancer trajectory
Patient-reported outcome PRO is an outcome that is reported by the patients Previous research on collecting PROs through an interactive application during treatment for breast cancer pancreatic cancer and prostate cancer shows promising results such as reduced symptom burden and improved QoL as well as survival Current research emphasizes the importance of user involvement in the development phase of web-based interventions and that its content is specific to the patients needs as well as delivered at the right stage in the cancer trajectory
The aim is to pilot- test routine assessment of patients reported symptoms and support in self-management assisted by digital technology for six months during the first year after primary treatment for breast cancer in combination with health dialogues with a study-specific nurse at the Primary healthcare centre The primary objective is to evaluate the acceptability and feasibility of a digital and nurse-led support intervention in primary healthcare for patients with breast cancer during the first year after primary treatment The secondary objectives of this trial are to i evaluate the potential efficacy of the intervention ii obtain estimates for secondary outcome measures and potential mediators and moderators to be used in a future trial and iii evaluate the feasibility of such assessments
There are 250 PHCCs within the region and to achieve representativeness for randomization the Care Need Index CNI for calculating economic compensation to the PHCC is used It measures healthcare needs for the distribution of primary care resources to the population with the biggest need A high CNI index equals low socioeconomic status and a low CNI index equals high socioeconomic status The intervention involves the entire PHCC and cluster randomisation is used to avoid a spill-over effect Approximately ten PHCCs will be matched on CNI index and the number of patients allocated to the PHCCs
Patient-reported outcome PRO is an outcome that is reported by the patients Previous research on collecting PROs through an interactive application during treatment for breast cancer pancreatic cancer and prostate cancer shows promising results such as reduced symptom burden and improved QoL as well as survival Current research emphasizes the importance of user involvement in the development phase of web-based interventions and that its content is specific to the patients needs as well as delivered at the right stage in the cancer trajectory
The aim is to pilot- test routine assessment of patients reported symptoms and support in self-management assisted by digital technology for six months during the first year after primary treatment for breast cancer in combination with health dialogues with a study-specific nurse at the Primary healthcare centre The primary objective is to evaluate the acceptability and feasibility of a digital and nurse-led support intervention in primary healthcare for patients with breast cancer during the first year after primary treatment The secondary objectives of this trial are to i evaluate the potential efficacy of the intervention ii obtain estimates for secondary outcome measures and potential mediators and moderators to be used in a future trial and iii evaluate the feasibility of such assessments
There are 250 PHCCs within the region and to achieve representativeness for randomization the Care Need Index CNI for calculating economic compensation to the PHCC is used It measures healthcare needs for the distribution of primary care resources to the population with the biggest need A high CNI index equals low socioeconomic status and a low CNI index equals high socioeconomic status The intervention involves the entire PHCC and cluster randomisation is used to avoid a spill-over effect Approximately ten PHCCs will be matched on CNI index and the number of patients allocated to the PHCCs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None