Breast CancerNCT06223022
Nurse-led Proactive Telephone Follow-up With Patients After Completion of Primary Cancer Treatment
A study testing Proactive nurse-led telephone follow-up in people with Breast Cancer and Colorectal Cancer, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- What is being tested?
- Proactive nurse-led telephone follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jan 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being primarily curatively treated for breast, colorectal-, or prostate cancer
Who cannot join
- no adjuvant treatment
- no cognitive impairment
- no known alcohol or other misuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- Being tested
- Proactive nurse-led telephone follow-up
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive nurse-led telephone follow-upBehavioural
An intervention nurse call the patients regularly with predetermined intervals and give support
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receiving regular telephone nurse-led support Receives: Behavioral: Proactive nurse-led telephone follow-up |
| Control | No intervention | Receiving care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' reported Quality of life
Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The questionnaire consists of 30 items. The QLQ-C30 is composed of both multi-item scales and single-items measures and includes five functional scales, three symptom scales, a global health status /QoL(quality of life) scale, and six single items.
Twenty-eight items are answered on a four-point Likert scale with response option labeled "Nor at all", "A little", "Quite a bit" and "Very Much". The last two questions have a seven point scale, ranging from 1 ("Very Poor") to seven ("Excellent"). Higher score for a functional scale represents a high/healthy level of functioning, a high score for the global health status represents a high QoL but a high score for a symptom scale/item represents a high level of symptomatology/problems. The minimum in values is 0, and maximum in values is 100.
Measured: Baseline, 3 months, 6 months and 12 months from inclusion
Secondary outcomes (6)
Patients' reported anxiety and depression
Measured by the Hospital Anxiety and Depression Scale (HADS) and consist of 14 items designed to measure anxiety and depression in patients' in somatic care. The scale is intended to measure and/or detect changes in anxiety and depressive symptoms in patients who are not in psychiatric care. HADS consists of seven statements for each sub-scale: HADS anxiety and HADS depression, where minimum is 0-21 for each sub scale. The higher scores indicates worse outcome.
Measured: Baseline, 3 months, 6 months and 12 months from inclusion
Patients' reported quality
Measured by EQ-5-D-5L. The EuroQol-5 dimension- 5 levels (EQ-5D-5L) descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five response levels: "no problem", "slight problems", "moderate problems", "severe problems" and "unable to/extreme problems". The last question is an EQ Visual Analogue Scale (VAS) assesses the overall current health, i.e., a quantitative measure of the patient's perception of their overall health. The lower score on the five specific dimensions indicate better outcome, while the higher score on the VAS scale indicate higher overall current health.
Measured: Baseline, 3 months, 6 months and 12 months from inclusion
Patients' perceptions of illness
Measured by The Brief Illness Perception Questionnaire (B- IPQ). The questionnaire has a total of nine items where the first eight questions are rated on a 0-10 scale. An overall score from eight questions are summed (range 0-80) and a higher number indicates a more threatening illness perception. However each item is representing a dimension and can be used so.
Measured: Baseline, 3 months, 6 months and 12 months from inclusion
Patients' experiences of breast cancer related to body image, sexual functioning, systemic therapy side effects and symptoms
Measured by The European Organisation for Research and Treatment of Cancer Quality of Life -The Breast Cancer module (EORTC QLQ-BR23).
The Breast Cancer module is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss.
All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Measured: Baseline, 3 months, 6 months and 12 months from inclusion
Patients' experiences of colorectal cancer related to symptoms and side effects of treatment and diagnosis.
Measured by The European Organisation for Research and Treatment of Cancer Quality of Life - The Colorectal Cancer Module (EORTC QLQ-CR29).
The European Organisation for Research and Treatment of Cancer Quality of Life - The Colorectal Cancer Module (EORTC QLQ-CR29) is a supplementary questionnaire module to be employed in conjunction QLQ-C30, and incorporates 4 multi-item scales and 19 single-items assessing a range of symptoms and problems common among patients with colorectal cancer.
All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.
Measured: Baseline, 3 months, 6 months and 12 months from inclusion
Patients' experiences of prostata cancer related to symptoms and side effects of treatment and diagnosis.
Measured by The European Organisation for Research and Treatment of Cancer Quality of Life -The Prostata Cancer module (EORTC QLQ-PR25). The QLQ-PR25 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30 and incorporates five multi-item scales to assess sexual activity, sexual functioning, urinary symptoms, bowel symptoms, and hormonal treatment-related symptoms. In addition, one single item assesses incontinence aid.
All of the scales and single-item measures range in score from 0 to 100. A high score for the Sexual Activity and Sexual Functioning scales represents a high level of functioning, whereas a high score for the Urinary, Bowel, and Hormonal Treatment-Related symptoms scales and Incontinence Aid item represents a high level of symptomatology or problems.
Measured: Baseline, 3 months, 6 months and 12 months from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start20 Jan 2024
- Primary completion30 Apr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Senada Hajdarevic, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223022
- Sponsor's protocol ID
- Department of Nursing
- Status last verified
- Mar 2025
- First submitted
- 4 Dec 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06223022
- Acronym / sponsor ID
- Department of Nursing
- Conditions
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Proactive nurse-led telephone follow-upReceiving regular telephone nurse-led support |
| Control | No intervention | –Receiving care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being primarily curatively treated for breast, colorectal-, or prostate cancer
Key exclusion criteria (3 listed)
- no adjuvant treatment
- no cognitive impairment
- no known alcohol or other misuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive nurse-led telephone follow-upAn intervention nurse call the patients regularly with predetermined intervals and give support | Behavioural | Intervention |
Primary outcome
Patients' reported Quality of life
Time frame: Baseline, 3 months, 6 months and 12 months from inclusion
Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The questionnaire consists of 30 items. The QLQ-C30 is composed of both multi-item scales and single-items measures and includes five functional scales, three symptom scales, a global health status /QoL(quality of life) scale, and six single items. Twenty-eight items are answered on a four-point Likert scale with response option labeled "Nor at all", "A little", "Quite a bit" and "Very Much". The last two questions have a seven point scale, ranging from 1 ("Very Poor") to seven ("Excellent"). Higher score for a functional scale represents a high/healthy level of functioning, a high score for the global health status represents a high QoL but a high score for a symptom scale/item represents a high level of symptomatology/problems. The minimum in values is 0, and maximum in values is 100.
6 secondary outcomes
Patients' reported anxiety and depression
Time frame: Baseline, 3 months, 6 months and 12 months from inclusion
Patients' reported quality
Time frame: Baseline, 3 months, 6 months and 12 months from inclusion
Patients' perceptions of illness
Time frame: Baseline, 3 months, 6 months and 12 months from inclusion
Patients' experiences of breast cancer related to body image, sexual functioning, systemic therapy side effects and symptoms
Time frame: Baseline, 3 months, 6 months and 12 months from inclusion
Patients' experiences of colorectal cancer related to symptoms and side effects of treatment and diagnosis.
Time frame: Baseline, 3 months, 6 months and 12 months from inclusion
Patients' experiences of prostata cancer related to symptoms and side effects of treatment and diagnosis.
Time frame: Baseline, 3 months, 6 months and 12 months from inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Senada Hajdarevic, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive nurse-led telephone follow-up in people with Breast Cancer and Colorectal Cancer, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' reported Quality of life (time frame: Baseline, 3 months, 6 months and 12 months from inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.