Breast CancerCPN ReadinessNCT07892157
Cancer Patient Navigation and Readiness
A study testing Cancer Patient Navigation Services in people with Breast Cancer and Breast Cancer and Rehabilitation, run by Universitas Muhammadiyah Semarang at 1 site in Indonesia.
Trial summary
This study evaluated whether Cancer Patient Navigation (CPN) services could improve readiness for the transition from breast cancer diagnosis to treatment. The study involved 64 women newly diagnosed with stage I-IIIA breast cancer who experienced high psychological distress at a cancer referral hospital in Indonesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer and Rehabilitation, Transition Care
- What is being tested?
- Cancer Patient Navigation Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndonesia
- Study dates
- 6 Jan 2026to 30 Mar 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria were: (1) newly diagnosed breast cancer confirmed by histopathological and/or radiological examination; (2) stage I-IIIA breast cancer; (3) no prior cancer-directed treatment, including surgery, chemotherapy, or radiotherapy, at baseline; (4) high psychological distress, defined as a score ≥7 on the National Comprehensive Cancer Network Distress Thermometer (NCCN-DT); and (5) willingness of patients and/or family members to use online meeting platforms or digital communication applications during the study.
Who cannot join
- Patients with a history of cancer other than breast cancer.
- Patients who are unwilling to participate as respondents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cancer Patient Navigation Services on Health-Illness Transition Readiness Among Women With Newly Diagnosed Breast Cancer: A Quasi-Experimental Study
This study evaluated whether Cancer Patient Navigation (CPN) services could improve readiness for the transition from breast cancer diagnosis to treatment.
The study involved 64 women newly diagnosed with stage I-IIIA breast cancer who experienced high psychological distress at a cancer referral hospital in Indonesia. Participants were assigned to either a navigation group or a standard care group without randomization.
Read more
Women in the navigation group received a 30-day support program that included education about breast cancer, guidance on treatment preparation, assistance with care coordination, and emotional support. The program included three to four hospital-based sessions during scheduled visits, a patient education booklet, and online nutrition education. Women in the comparison group received standard care.
Participants' readiness to manage changes related to their cancer diagnosis and prepare for treatment was assessed before and after the study using the Measurement of Transitions in Cancer Scale.
The study aimed to determine whether women receiving navigation services experienced greater improvements in transition readiness than those receiving standard care.
Read the detailed description
Women newly diagnosed with breast cancer often experience emotional distress, uncertainty, and difficulties adjusting to their diagnosis. The period between diagnosis and treatment initiation is an important phase of the health-illness transition, during which patients must understand their condition, make treatment-related decisions, and adapt to changing healthcare needs.
Cancer Patient Navigation (CPN) is a patient-centered approach designed to help individuals overcome barriers to healthcare access and receive coordinated support throughout their cancer care journey. In addition to facilitating healthcare services, navigation may help patients develop the knowledge, confidence, and preparedness needed to manage changes associated with their diagnosis.
This study used a quasi-experimental pretest-posttest design with a nonrandomized control group to evaluate whether structured navigation services were associated with improved health-illness transition readiness among women newly diagnosed with breast cancer.
The study focused on transition readiness as a patient-centered outcome, extending beyond commonly examined navigation outcomes such as healthcare access, treatment timeliness, and care coordination. The findings may inform the development of supportive oncology nursing interventions during the early stages of breast cancer care.
- Conditions
- Breast Cancer, Breast Cancer and Rehabilitation, Transition Care, Breast Cancer - Female, Newly Diagnosed Breast Cancer
- Being tested
- Cancer Patient Navigation Services
- Keywords
- Breast Neoplasms, Patient Navigation, Transitional Care, Adaptation, Psychological, Newly Diagnosed Breast Cancer.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Patient Navigation ServicesBehavioural
Also called Cancer Patient Navigator
The intervention consisted of a structured 30-day Cancer Patient Navigation program for women newly diagnosed with breast cancer. Participants received three to four hospital-based navigation sessions during scheduled clinical visits. The program provided education about breast cancer, guidance on treatment preparation, assistance with healthcare coordination, and psychosocial support. Additional resources included a patient education booklet and online nutrition education. The intervention aimed to support patients in understanding their diagnosis, addressing care-related needs, and preparing for the transition from diagnosis to treatment initiation.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Patient Navigation Group | Experimental | Participants in this group received a structured 30-day Cancer Patient Navigation program consisting of three to four hospital-based sessions during scheduled visits. The intervention included breast cancer education, clinical guidance, care coordination, psychosocial support, an educational booklet, and online nutrition education. Receives: Behavioral: Cancer Patient Navigation Services |
| Standard Care Group | No intervention | Participants in this group received standard care provided by the hospital without the additional structured Cancer Patient Navigation intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health-Illness Transition Readiness
Health-illness transition readiness was assessed using the Measurement of Transitions in Cancer Scale (MOT-CA). The primary outcome was the change in transition readiness scores from baseline to post-intervention, comparing women who received Cancer Patient Navigation services with those who received standard care. The assessment included the care transition and management of change domains.
Measured: Baseline and 30 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start6 Jan 2026
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study employed a quasi-experimental pretest-posttest design with two parallel, nonrandomized groups. Participants in the intervention group received a structured 30-day Cancer Patient Navigation program, while those in the control group received standard care. Health-illness transition readiness was assessed in both groups before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Muhammadiyah Semarang
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesia Endowment Fund for Education (LPDP), Ministry of Finance Republik of Indonesia, Gadjah Mada University
- Responsible party
- Principal investigator, Agung Subakti Nuzulullail, Universitas Muhammadiyah Semarang
- Investigators
- Agung Subakti Nuzulullail, BSN., RN., M.N.Sc., Principal investigator, Universitas Muhammadiyah Semarang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892157
- Sponsor's protocol ID
- KE/FK/1756/EC/2025
- Other IDs
- KE/FK/1756/EC/2025
- Acronym
- CPN Readiness
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly to protect participant confidentiality and privacy. The dataset contains sensitive health-related information from women diagnosed with breast cancer. Access to individual-level data will remain restricted to the research team in accordance with applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cancer Patient Navigation Services on Health-Illness Transition Readiness Among Women With Newly Diagnosed Breast Cancer: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07892157
- Acronym / sponsor ID
- CPN Readiness / KE/FK/1756/EC/2025
- Conditions
- Breast Cancer, Breast Cancer and Rehabilitation, Transition Care, Breast Cancer - Female, Newly Diagnosed Breast Cancer
- Keywords
- Breast Neoplasms, Patient Navigation, Transitional Care, Adaptation, Psychological, Newly Diagnosed Breast Cancer.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universitas Muhammadiyah SemarangUniversity, hospital or other
- Collaborators
- Indonesia Endowment Fund for Education (LPDP), Ministry of Finance Republik of Indonesia, Gadjah Mada University
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 23 Oct 2026 (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.
This study evaluated whether Cancer Patient Navigation (CPN) services could improve readiness for the transition from breast cancer diagnosis to treatment.
The study involved 64 women newly diagnosed with stage I-IIIA breast cancer who experienced high psychological distress at a cancer referral hospital in Indonesia. Participants were assigned to either a navigation group or a standard care group without randomization.
Women in the navigation group received a 30-day support program that included education about breast cancer, guidance on treatment preparation, assistance with care coordination, and emotional support. The program included three to four hospital-based sessions during scheduled visits, a patient education booklet, and online nutrition education. Women in the comparison group received standard care.
Participants' readiness to manage changes related to their cancer diagnosis and prepare for treatment was assessed before and after the study using the Measurement of Transitions in Cancer Scale.
The study aimed to determine whether women receiving navigation services experienced greater improvements in transition readiness than those receiving standard care.
Detailed description
Women newly diagnosed with breast cancer often experience emotional distress, uncertainty, and difficulties adjusting to their diagnosis. The period between diagnosis and treatment initiation is an important phase of the health-illness transition, during which patients must understand their condition, make treatment-related decisions, and adapt to changing healthcare needs.
Cancer Patient Navigation (CPN) is a patient-centered approach designed to help individuals overcome barriers to healthcare access and receive coordinated support throughout their cancer care journey. In addition to facilitating healthcare services, navigation may help patients develop the knowledge, confidence, and preparedness needed to manage changes associated with their diagnosis.
This study used a quasi-experimental pretest-posttest design with a nonrandomized control group to evaluate whether structured navigation services were associated with improved health-illness transition readiness among women newly diagnosed with breast cancer.
The study focused on transition readiness as a patient-centered outcome, extending beyond commonly examined navigation outcomes such as healthcare access, treatment timeliness, and care coordination. The findings may inform the development of supportive oncology nursing interventions during the early stages of breast cancer care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employed a quasi-experimental pretest-posttest design with two parallel, nonrandomized groups. Participants in the intervention group received a structured 30-day Cancer Patient Navigation program, while those in the control group received standard care. Health-illness transition readiness was assessed in both groups before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Cancer Patient Navigation Group | Experimental | Behavioral: Cancer Patient Navigation ServicesParticipants in this group received a structured 30-day Cancer Patient Navigation program consisting of three to four hospital-based sessions during scheduled visits. The intervention included breast cancer education, clinical guidance, care coordination, psychosocial support, an educational booklet, and online nutrition education. |
| Standard Care Group | No intervention | –Participants in this group received standard care provided by the hospital without the additional structured Cancer Patient Navigation intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria were: (1) newly diagnosed breast cancer confirmed by histopathological and/or radiological examination; (2) stage I-IIIA breast cancer; (3) no prior cancer-directed treatment, including surgery, chemotherapy, or radiotherapy, at baseline; (4) high psychological distress, defined as a score ≥7 on the National Comprehensive Cancer Network Distress Thermometer (NCCN-DT); and (5) willingness of patients and/or family members to use online meeting platforms or digital communication applications during the study.
Key exclusion criteria (2 listed)
- Patients with a history of cancer other than breast cancer.
- Patients who are unwilling to participate as respondents.
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 |
|---|---|---|
| Cancer Patient Navigation ServicesAlso: Cancer Patient NavigatorThe intervention consisted of a structured 30-day Cancer Patient Navigation program for women newly diagnosed with breast cancer. Participants received three to four hospital-based navigation sessions during scheduled clinical visits. The program provided education about breast cancer, guidance on treatment preparation, assistance with healthcare coordination, and psychosocial support. Additional resources included a patient education booklet and online nutrition education. The intervention aimed to support patients in understanding their diagnosis, addressing care-related needs, and preparing for the transition from diagnosis to treatment initiation. | Behavioural | Cancer Patient Navigation Group |
Primary outcome
Change in Health-Illness Transition Readiness
Time frame: Baseline and 30 days after baseline
Health-illness transition readiness was assessed using the Measurement of Transitions in Cancer Scale (MOT-CA). The primary outcome was the change in transition readiness scores from baseline to post-intervention, comparing women who received Cancer Patient Navigation services with those who received standard care. The assessment included the care transition and management of change domains.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly to protect participant confidentiality and privacy. The dataset contains sensitive health-related information from women diagnosed with breast cancer. Access to individual-level data will remain restricted to the research team in accordance with applicable ethical and institutional requirements.
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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.
Agung Subakti Nuzulullail, BSN., RN., M.N.Sc. principal investigator
Universitas Muhammadiyah Semarang
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Patient Navigation Services in people with Breast Cancer and Breast Cancer and Rehabilitation, run by Universitas Muhammadiyah Semarang at 1 site in Indonesia.
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 2 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: finished, as of the sponsor's last update on 23 Oct 2026. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Health-Illness Transition Readiness (time frame: Baseline and 30 days after baseline). 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 23 Oct 2026.