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CompletedNCT07892157CPN ReadinessUpdated Oct 23, 2026

Cancer Patient Navigation and Readiness

An interventional study of Cancer Patient Navigation Services in Breast Cancer, Breast Cancer and Rehabilitation and Transition Care, sponsored by Universitas Muhammadiyah Semarang. Completed at 1 site in Indonesia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Universitas Muhammadiyah Semarang · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2026, registered Oct 2026).
Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

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.

02

Conditions studied

  • Breast Cancer
  • Breast Cancer and Rehabilitation
  • Transition Care
  • Breast Cancer - Female
  • Newly Diagnosed Breast Cancer

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Keywords

  • Breast Neoplasms
  • Patient Navigation
  • Transitional Care
  • Adaptation
  • Psychological
  • Newly Diagnosed Breast Cancer.
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In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.

This study's enrollment of 64 is below the median of 72 across 9,498 interventional studies indexed under Breast Neoplasms.

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Lead sponsor

Universitas Muhammadiyah Semarang is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  1. Patients with a history of cancer other than breast cancer.
  2. Patients who are unwilling to participate as respondents.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Cancer Patient Navigation Group

    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.

    Behavioral: Cancer Patient Navigation Services

  • No intervention
    Standard Care Group

    Participants in this group received standard care provided by the hospital without the additional structured Cancer Patient Navigation intervention.

Interventions

  • BehavioralCancer Patient Navigation Services

    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.

    Also known as: Cancer Patient Navigator

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 30 days after baseline

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Study locations

1 site
  • RSUP Dr. Sardjito
    Yogyakarta, 55281, Indonesia
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References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07892157
Lead sponsor
Universitas Muhammadiyah Semarang
Collaborators
Indonesia Endowment Fund for Education (LPDP), Ministry of Finance Republik of Indonesia, Gadjah Mada University
Responsible party
Agung Subakti Nuzulullail (Lecturer, Universitas Muhammadiyah Semarang) — Principal investigator
First posted
Oct 23, 2026
Start date
Jan 6, 2026
Primary completion
Mar 30, 2026
Completion
Mar 30, 2026
Last update
Oct 23, 2026

Study contacts

Agung Subakti Nuzulullail, BSN., RN., M.N.Sc.
principal investigator · Universitas Muhammadiyah Semarang

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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