To Live Better After Breast Cancer Treatment - a Randomized Pilot Trial of a Supportive and Person-centered Care Intervention in Primary Healthcare

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• patients with breast cancer at the end of curative treatment

• able to read and understand Swedish

• considered being physically, psychologically and cognitively able to participate in the study

Locations
Other Locations
Sweden
Health Care Services Stockholm County (SLSO)
RECRUITING
Stockholm
Contact Information
Primary
Kristina Rooth, MSc
kristina.rooth@ki.se
0046707526845
Backup
Ann Langius Eklöf, Professor
ann.langius-eklöf@ki.se
0046722535878
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 40
Treatments
Experimental: Intervention group
The intervention consists of standard care and the app (called Interaktor) for routine symptom reporting of common symptoms regarding fatigue, emotional distress, sleep, pain, loss of appetite, hot flashes/sweating, edema, and sexual health, in combination with health dialogues with a study-specific nurse. The reports are made weekly during the first month and thereafter as mutually agreed, at minimum once a month for six months, with instant self-care advice in combination with supportive care with a study-specific nurse. At health dialogues with the study-specific nurse, the patient-reported assessments in the app will be used to discuss the individual's current situation and to plan eventual additional actions needed.~The intervention will last for 6 months.
No_intervention: Control group
The participants in the control group will only receive standard care in the secondary care setting. Usually after ended primary treatment the follow-up is determined based on the severity of the tumour, the received postoperative treatment and the patient's general health status. Patients should be offered a yearly follow-up for at least five years where the patients are made a part of the decision-making process of the structure of the follow-up. All patients are allocated a contact nurse with a telephone number to contact when needed.
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov