Clinical trial NCT06223022: Nurse-led Proactive Telephone Follow-up With Patients After Completion of Primary Cancer Treatment
Official title: How Are You Getting on? Nurse-led Proactive Telephone Follow-up With Patients After Completion of Primary Cancer Treatment Increases Their Sense of Security and Well-being
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Prostate Cancer
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized study is to test and evaluate nurse-led telephone follow-up intervention in patients primarily curatively treated for breast cancer, colorectal cancer, and prostate cancer.

The main question aims to answer:

Does this nurse-led telephone follow-up improve patients' quality of life? Participants in both groups will be asked to fill in questionnaires regularly. The intervention group will get a telephone follow-up at predetermined intervals, while the control group will get the care as usual.The investigators will compare intervention and control groups to see if predetermined regular nurse-led telephone follow-up improves quality of life.

Detailed description: The hypothesis is that nurse-led telephone follow-up will improve the quality of life in patients primarily curatively treated for breast cancer, colorectal cancer, and prostate cancer.

Participants in both groups will respond to a survey regularly during one year from inclusion. The intervention group will get a telephone follow-up at predetermined intervals (1, 3, 6, 9, 12 months) while the control group will get the care as usual. The usual care means that no proactive support is offered to patients from health care while they wait for follow-up, but patients are of course allowed to contact health care if they needed.

Participants in both groups are asked to respond on a survey concerning their quality of life, feelings of anxiety and depression, perception of illness, and experienced symptoms and discomfort regarding to cancer. Additionally, the number of visits at the health care during the waiting for follow-up will be collected from both group.

Eligibility criteria: Inclusion Criteria:

* Being primarily curatively treated for breast, colorectal-, or prostate cancer

Exclusion Criteria:

* no adjuvant treatment
* no cognitive impairment
* no known alcohol or other misuse

Primary outcomes:
measure: Patients' reported Quality of life
timeFrame: Baseline, 3 months, 6 months and 12 months from inclusion
Secondary outcomes:
measure: Patients' reported anxiety and depression
timeFrame: Baseline, 3 months, 6 months and 12 months from inclusion
measure: Patients' reported quality
timeFrame: Baseline, 3 months, 6 months and 12 months from inclusion
measure: Patients' perceptions of illness
timeFrame: Baseline, 3 months, 6 months and 12 months from inclusion
measure: Patients' experiences of breast cancer related to body image, sexual functioning, systemic therapy side effects and symptoms
timeFrame: Baseline, 3 months, 6 months and 12 months from inclusion
measure: Patients' experiences of colorectal cancer related to symptoms and side effects of treatment and diagnosis.
timeFrame: Baseline, 3 months, 6 months and 12 months from inclusion
measure: Patients' experiences of prostata cancer related to symptoms and side effects of treatment and diagnosis.
timeFrame: Baseline, 3 months, 6 months and 12 months from inclusion
Other outcomes:
measure: Health-care consumption
timeFrame: Through study completion, an average of 1 year
measure: Sick-leave
timeFrame: Through study completion, an average of 1 year
Locations:
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus
Study officials:
affiliation: Umeå University
name: Senada Hajdarevic, PhD
role: PRINCIPAL_INVESTIGATOR
References: