NCT01824745

Brief Summary

This randomized pilot clinical trial studies survivorship care planning in improving the quality of life in breast cancer survivors. Survivorship care planning may reduce stress and improve the well-being and quality of life of cancer survivors.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
1mo left

Started Jul 2013

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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 Progress99%
Jul 2013Jun 2026

First Submitted

Initial submission to the registry

April 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2013

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

12.9 years

First QC Date

April 2, 2013

Last Update Submit

March 11, 2026

Conditions

Breast CancerCancer Survivor

Outcome Measures

Primary Outcomes (1)

  • Proportion of BCS accessing a SCP from their oncology provider

    Fisher's exact test will be used to test the null hypothesis (at least 40% of trial participants will have access to SCP).

    At 6 months

Secondary Outcomes (2)

  • Adherence to SCP guidelines

    At 12 months

  • Proportion of BCS accessing a SCP from their oncology provider

    At 12 months

Other Outcomes (1)

  • Develop a clinically and psychosocially responsive SCP-BCS template in English and a linguistically response bilingual version (English-Spanish)

    Up to 12 months

Study Arms (2)

Arm I (SCP-BCS template booklet and counseling)

EXPERIMENTAL

Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.

Other: educational interventionOther: counseling interventionProcedure: quality-of-life assessmentOther: questionnaire administration

Arm II (SCP-BCS template booklet)

ACTIVE COMPARATOR

Participants receive SCP-BCS template booklet and receive standard follow-up care.

Other: educational interventionProcedure: standard follow-up careProcedure: quality-of-life assessmentOther: questionnaire administration

Interventions

counseling interventionOTHER

Receive counseling sessions with a patient navigator

Also known as: counseling and communications studies
Arm I (SCP-BCS template booklet and counseling)
standard follow-up carePROCEDURE

Receive standard follow-up care

Arm II (SCP-BCS template booklet)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm I (SCP-BCS template booklet and counseling)Arm II (SCP-BCS template booklet)
questionnaire administrationOTHER

Ancillary studies

Arm I (SCP-BCS template booklet and counseling)Arm II (SCP-BCS template booklet)
educational interventionOTHER

Receive the SCP-BCS template booklet

Also known as: intervention, educational
Arm I (SCP-BCS template booklet and counseling)Arm II (SCP-BCS template booklet)

Eligibility Criteria

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

You may qualify if:

  • In early survivorship phase, defined as being post-surgery to ending of active treatment to 18 months post active treatment for stage 0-3 breast cancer (BCA)
  • Reside in Southern California
  • BCS treated at Kaiser, an health maintenance organization (HMO) provider, will be excluded since their SCP implementation project is underway
  • BCS will not be excluded based on cancer treatments received or a history of diagnosis of mild depression, anxiety, and hypertension and diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope Antelope Valley

Lancaster, California, 93534, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Early Intervention, EducationalMethodsCounseling

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative TechniquesMental Health ServicesBehavioral Disciplines and Activities

Study Officials

  • Kimlin Ashing-Giwa

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 5, 2013

Study Start

July 15, 2013

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

US(2)