NCT07892157

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

3 months

First QC Date

October 17, 2026

Last Update Submit

October 17, 2026

Conditions

Keywords

Breast NeoplasmsPatient NavigationTransitional CareAdaptationPsychologicalNewly Diagnosed Breast Cancer.

Outcome Measures

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.

    Baseline and 30 days after baseline

Study Arms (2)

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.

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.

Interventions

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
Cancer Patient Navigation Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUP Dr. Sardjito

Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Agung Subakti Nuzulullail, BSN., RN., M.N.Sc.

    Universitas Muhammadiyah Semarang

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 17, 2026

First Posted

October 23, 2026

Study Start

January 6, 2026

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

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.

Locations