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

Breast Cancer Clinical Trial

Official title:

Survivorship Care Planning for At Risk Breast Cancer Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01824745
• Other study ID #: 12383
• Secondary ID: NCI-2013-00734
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2013
• Est. completion date: December 15, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Survivor

Intervention

Other:
• educational intervention
Receive the SCP-BCS template booklet
• counseling intervention
Receive counseling sessions with a patient navigator

Procedure:
• standard follow-up care
Receive standard follow-up care
• quality-of-life assessment
Ancillary studies

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California
United States	City of Hope Antelope Valley	Lancaster	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Develop a clinically and psychosocially responsive SCP-BCS template in English and a linguistically response bilingual version (English-Spanish)	The acceptability, utility, and format preference will also be assessed. A rating score will be generated for acceptability and utility and 95% confidence intervals for the proportion of BCS rating score at >= 4 will be assessed.	Up to 12 months
Primary	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	Adherence to SCP guidelines	Fisher's exact test will be used to test the null hypothesis (at least 25% of participants reporting adherence to SCP guidelines).	At 12 months
Secondary	Proportion of BCS accessing a SCP from their oncology provider	Fisher's exact test will be used to test the null hypothesis (at least 60% of trial participants will have access to SCP).	At 12 months