Prostate CancerCAPPRISNCT05100121
To Live Better After Prostate Cancer Treatment:
A study testing Interactive app and Supportive Care in people with Prostate Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
It is evident that patients receiving treatment for cancer have symptoms that often are undetected. 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Interactive app and Supportive Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 17 Oct 2023to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with prostate 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Health Care Services Stockholm County (SLSO)
Stockholm
Nazmije Kelmendi, PhD student, 46 (0)70 267 78 69, nazmije.kelmendi@ki.se
About this study
Official title: To Live Better After Prostate Cancer Treatment: a Randomized Pilot Trial of Supportive and Person-centered Care Intervention in Primary Care
It is evident that patients receiving treatment for cancer have symptoms that often are undetected. 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 intervention in primary care for six months during the first year after primary treatment for prostate cancer in primary care and compare it to standard care only. The intervention consists of symptom reporting and self-management in an app in combination with health dialogues with a study-specific nurse at a primary care centre.
Read the detailed description
Prostate cancer is the most common form of cancer in Sweden and the most common form of cancer among men in Sweden, representing approximately 30 percent of all cancer cases among men. The median age for being diagnosed with prostate cancer is around 69. The treatments available for prostate cancer can impact the patients; quality of life (QoL) (Katz, 2007). After surgery and radiation treatment, the function of the bowel and bladder is affected. Erectile dysfunction is common after surgery, radiation, and hormonal therapy. Symptoms and side effects can start quite suddenly, get improved, but also persist a long time after treatment.
Psychosocial support to patients during the treatment shows different results, some with positive effects on QoL by psychoeducational or nurse-delivered interventions and some with no effect at all.
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 on survival. A synthesis of current research on web-based interventions shows how important it is that content is specific to the patients\' needs and delivered at the right stage in the cancer trajectory and emphasize user involvement in the developmental phase.
The aim is to pilot-test routine assessment of patient reported symptoms and support in self-management assisted by digital technology for six months during the first year after primary treatment for prostate cancer in combination with helath dialouges with a study-specific nurse at the primary care centre.
The primary objective is to evaluate the acceptability and feasibility of digital and nurse-led support intervention in primary care during the first after primary treatment. The secondary objectives of these trials are to (i) evaluate the potential efficacy of the intervention and (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 around 250 Primary Health Care Centers (PHCC) in Stockholm and to achieve representative PHCCs for randomization a Care Need Index (CNI) is used. CNI is a model that measures healthcare needs for the distribution of primary care resources to the population with the biggest need. High CNI index equals low socioeconomic status and low CNI index equals high socioeconomic status. The study has a prospective, cluster randomized controlled pilot trial design The studies have two parallel arms; the intervention plus standard care (intervention group); and standard care alone (control group). Approximately ten PHCCs will be matched on CNI index and the number of patients allocated to the PHCCs.
- Conditions
- Prostate Cancer
- Being tested
- Interactive app, Supportive Care
- Keywords
- mobile health, Prostate cancer, Symptom management, primary care, self- management, Support
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive appDevice
In the app, the patients will report frequency and distress on commons concerns regarding urine dysfunction, bowel dysfunction, emotional distress, sleep, pain, loss of appetite, hot flashes/sweating, edema, and sexual dysfunction. Free text comments will also be possible to make to cover the patients' other potential needs. Questions regarding symptoms of acute character that might need to be treated quickly like severe pain, blood in stool and urine, and involuntary weight loss will also be asked for to timely detect and treat signs of for example cancer relapse. Information about the concerns will be included in the app containing; a) general information of why they have the side effect and what it means b) evidence-based advice about self-management; c) when they should contact health care providers, and d) further information linked to reliable documents and web pages.
Supportive CareOther
During the health dialogues with the nurse, the patient reported assessments will be used to discuss the individual's current situation and to plan eventual additional actions needed such as support from a physiotherapist, social worker, dietitian or if a visit to the physician if needed. This is documented in the patients health record.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention consists of standard care and an app for routine symptom reporting, weekly the first month and thereafter as mutually agreed, at minimum once a month in one year, with instant self-managment advice in combination with supportive care with a study-specific nurse. At health dialogues with the 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. Receives: Device: Interactive app; Other: Supportive Care |
| Control | No intervention | The participants in the control group will only receive standard care. Usually after ended curative treatment the follow-up is a blood sample (PSA) every three or six months the first year, this can be handled either by a nurse or a physician in secondary care. Most hospitals also have one physical meeting with a physician three months after ended treatment (Regional Cancer Centers, 2020). All patients are allocated a contact nurse with a telephone number to contact when needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability E -scale
The Acceptability e-scale is a questionnaire with 6 items that evaluate the acceptability of a system. Items are scored using a Likert scale ranging from 1-5 with higher values indicating higher acceptability.
Measured: 6 months
System Usability Scale (Q5 and Q10)
The System Usability Scala is a questionnaire with ten item that evaluate the usability of a system. Items are scored using a Likert scale ranging from 1-5. Only question 5 and 10 will be included in this study.
Measured: 6 months
Interviews
To assess acceptability and feasibility, the participants in the intervention group and the study specific nurses will be interviewed about their experinece using the Interaktor system and about the health dialouges.
Measured: 7 months
Other feasibility measures
To evaluate the feasibility of the future trial methodology, enrollment, recruitment, and withdrawal rates will be documented. Other feasibility measures include completion rates and missing data in each study questionnaire. Objective measures will be extracted from the logged data in the app, i.e., the number of reports sent (adherence), self-managment advice viewings, and notes from the study-specific nurses.
Measured: Through study completion, an avrage of 24 months
Secondary outcomes (6)
Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module
The questionnaire has 25 items and evaluates specific prostate cancer symptoms related to treatment such as sexual function and bladder and bowel problem. Items are scored using a Likert scale ranging from 1-4 with higher values indicating more burden of symptoms and divided in six sub-scales.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Quality of Life measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
The questionnaire has 30 items divided in five functional scales (physical, role, emotional, social, and cognitive), eight symptom scales (fatigue, nausea and vomiting, pain, insomnia, appetite loss, constipation, diarrhea), financial impact of the disease, and a global health status/QoL scale. Questions are scored using a Likert scale ranging from 1-4 with higher values indicating lower QoL.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
The Patient Activation Measure (PAM -13)
The PAM-13 questionnaires has 13 items measure knowledge, skils, beliefs, and confidence in managin health and healthcare.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Quality of life measured measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)
For this study used together with direct costs to analyse Quality of adjusted life years by weighting life expectancy of a patient against estimation of a persons' health related Quality of Life score.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
The Sence of Coherence Scale (SOC-13)
The SOC-13 questionnaire measure overall coping ability.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Health Literacy CCHL (5-items)
The questionnaire has five items measuring the ability to read and understand information regarding health, disease and health care
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start17 Oct 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Langius-Eklöf, Karolinska Institutet
- Investigators
- Ann Langius-Eklöf, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100121
- Sponsor's protocol ID
- Dnr-2019-0037
- Acronym
- CAPPRIS
- Status last verified
- Sep 2024
- First submitted
- 8 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langius-Eklof A, Craftman AG, Gellerstedt L, Kelmendi N, Rooth K, Gustavell T, Sundberg K. Digital and nurse-led support intervention in primary care during the first year after curative intent treatment for breast or prostate cancer: study protocol of two cluster randomised controlled pilot trials. BMJ Open. 2025 Feb 22;15(2):e090848. doi: 10.1136/bmjopen-2024-090848.
PubMed 39986997
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Live Better After Prostate Cancer Treatment: a Randomized Pilot Trial of Supportive and Person-centered Care Intervention in Primary Care
- ClinicalTrials.gov ID
- NCT05100121
- Acronym / sponsor ID
- CAPPRIS / Dnr-2019-0037
- Conditions
- Prostate Cancer
- Keywords
- mobile health, Prostate cancer, Symptom management, primary care, self- management, Support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 29 Oct 2021 (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.
It is evident that patients receiving treatment for cancer have symptoms that often are undetected. 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 intervention in primary care for six months during the first year after primary treatment for prostate cancer in primary care and compare it to standard care only. The intervention consists of symptom reporting and self-management in an app in combination with health dialogues with a study-specific nurse at a primary care centre.
Detailed description
Prostate cancer is the most common form of cancer in Sweden and the most common form of cancer among men in Sweden, representing approximately 30 percent of all cancer cases among men. The median age for being diagnosed with prostate cancer is around 69. The treatments available for prostate cancer can impact the patients; quality of life (QoL) (Katz, 2007). After surgery and radiation treatment, the function of the bowel and bladder is affected. Erectile dysfunction is common after surgery, radiation, and hormonal therapy. Symptoms and side effects can start quite suddenly, get improved, but also persist a long time after treatment.
Psychosocial support to patients during the treatment shows different results, some with positive effects on QoL by psychoeducational or nurse-delivered interventions and some with no effect at all.
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 on survival. A synthesis of current research on web-based interventions shows how important it is that content is specific to the patients\' needs and delivered at the right stage in the cancer trajectory and emphasize user involvement in the developmental phase.
The aim is to pilot-test routine assessment of patient reported symptoms and support in self-management assisted by digital technology for six months during the first year after primary treatment for prostate cancer in combination with helath dialouges with a study-specific nurse at the primary care centre.
The primary objective is to evaluate the acceptability and feasibility of digital and nurse-led support intervention in primary care during the first after primary treatment. The secondary objectives of these trials are to (i) evaluate the potential efficacy of the intervention and (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 around 250 Primary Health Care Centers (PHCC) in Stockholm and to achieve representative PHCCs for randomization a Care Need Index (CNI) is used. CNI is a model that measures healthcare needs for the distribution of primary care resources to the population with the biggest need. High CNI index equals low socioeconomic status and low CNI index equals high socioeconomic status. The study has a prospective, cluster randomized controlled pilot trial design The studies have two parallel arms; the intervention plus standard care (intervention group); and standard care alone (control group). Approximately ten PHCCs will be matched on CNI index and the number of patients allocated to the PHCCs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Interactive app, Other: Supportive CareThe intervention consists of standard care and an app for routine symptom reporting, weekly the first month and thereafter as mutually agreed, at minimum once a month in one year, with instant self-managment advice in combination with supportive care with a study-specific nurse. At health dialogues with the 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. |
| Control | No intervention | –The participants in the control group will only receive standard care. Usually after ended curative treatment the follow-up is a blood sample (PSA) every three or six months the first year, this can be handled either by a nurse or a physician in secondary care. Most hospitals also have one physical meeting with a physician three months after ended treatment (Regional Cancer Centers, 2020). All patients are allocated a contact nurse with a telephone number to contact when needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with prostate 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Interactive appIn the app, the patients will report frequency and distress on commons concerns regarding urine dysfunction, bowel dysfunction, emotional distress, sleep, pain, loss of appetite, hot flashes/sweating, edema, and sexual dysfunction. Free text comments will also be possible to make to cover the patients' other potential needs. Questions regarding symptoms of acute character that might need to be treated quickly like severe pain, blood in stool and urine, and involuntary weight loss will also be asked for to timely detect and treat signs of for example cancer relapse. Information about the concerns will be included in the app containing; a) general information of why they have the side effect and what it means b) evidence-based advice about self-management; c) when they should contact health care providers, and d) further information linked to reliable documents and web pages. | Device | Intervention |
| Supportive CareDuring the health dialogues with the nurse, the patient reported assessments will be used to discuss the individual's current situation and to plan eventual additional actions needed such as support from a physiotherapist, social worker, dietitian or if a visit to the physician if needed. This is documented in the patients health record. | Other | Intervention |
Primary outcome
Acceptability E -scale
Time frame: 6 months
The Acceptability e-scale is a questionnaire with 6 items that evaluate the acceptability of a system. Items are scored using a Likert scale ranging from 1-5 with higher values indicating higher acceptability.
System Usability Scale (Q5 and Q10)
Time frame: 6 months
The System Usability Scala is a questionnaire with ten item that evaluate the usability of a system. Items are scored using a Likert scale ranging from 1-5. Only question 5 and 10 will be included in this study.
Interviews
Time frame: 7 months
To assess acceptability and feasibility, the participants in the intervention group and the study specific nurses will be interviewed about their experinece using the Interaktor system and about the health dialouges.
Other feasibility measures
Time frame: Through study completion, an avrage of 24 months
To evaluate the feasibility of the future trial methodology, enrollment, recruitment, and withdrawal rates will be documented. Other feasibility measures include completion rates and missing data in each study questionnaire. Objective measures will be extracted from the logged data in the app, i.e., the number of reports sent (adherence), self-managment advice viewings, and notes from the study-specific nurses.
6 secondary outcomes
Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Quality of Life measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
The Patient Activation Measure (PAM -13)
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Quality of life measured measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
The Sence of Coherence Scale (SOC-13)
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Health Literacy CCHL (5-items)
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 39986997Langius-Eklof A, Craftman AG, Gellerstedt L, Kelmendi N, Rooth K, Gustavell T, Sundberg K. Digital and nurse-led support intervention in primary care during the first year after curative intent treatment for breast or prostate cancer: study protocol of two cluster randomised controlled pilot trials. BMJ Open. 2025 Feb 22;15(2):e090848. doi: 10.1136/bmjopen-2024-090848.
- 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. This study is not recruiting at the moment.
Ann Langius-Eklöf, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive app and Supportive Care in people with Prostate Cancer, run by Karolinska Institutet 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazmije Kelmendi, PHDstudent (0046-702677869, nazmije.kelmendi@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability E -scale (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05100121, which also lists 1 linked publication.
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 19 Sep 2024.