NCT01824745

Survivorship Care Planning in Improving the Quality of Life in Breast Cancer Survivors

Survivorship Care Planning for At Risk Breast Cancer Survivors

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Test the effectiveness of the navigation intervention and survivorship care plan (SCP)-breast cancer survivors (BCS) template booklet on accessing and adhering to SCP-BCS guidelines compared to the control group receiving usual care and the SCP-BCS template booklet. SECONDARY OBJECTIVES: I. Develop a clinically and psychosocially responsive SCP-breast cancer survivors (SCP-BCS) template in English and English-Spanish adopted from American Society of Clinical Oncology (ASCO)-SCP. II. Assess the acceptability, utility and format preference (electronic vs paper) of the SCP-BCS template. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions. ARM II: Participants receive SCP-BCS template booklet and receive standard follow-up care. After completion so study treatment, participants are followed up at 6 and 12 months.

Conditions

• Breast Cancer
• Cancer Survivor

Interventions

Type	Name	Description
OTHER	educational intervention	Receive the SCP-BCS template booklet
OTHER	counseling intervention	Receive counseling sessions with a patient navigator
PROCEDURE	standard follow-up care	Receive standard follow-up care
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2013-07-15
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2013-04-05
• Last updated: 2026-03-13

Locations

2 sites across 1 country: United States