search
Back to results

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

Primary Purpose

Breast Cancer, Cancer Survivor

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
counseling intervention
standard follow-up care
quality-of-life assessment
questionnaire administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center
  • City of Hope Antelope Valley

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (SCP-BCS template booklet and counseling)

Arm II (SCP-BCS template booklet)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
April 2, 2013
Last Updated
July 3, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01824745
Brief Title
Survivorship Care Planning in Improving the Quality of Life in Breast Cancer Survivors
Official Title
Survivorship Care Planning for At Risk Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2013 (undefined)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer Survivor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (SCP-BCS template booklet and counseling)
Arm Type
Experimental
Arm Description
Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.
Arm Title
Arm II (SCP-BCS template booklet)
Arm Type
Active Comparator
Arm Description
Participants receive SCP-BCS template booklet and receive standard follow-up care.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Receive the SCP-BCS template booklet
Intervention Type
Other
Intervention Name(s)
counseling intervention
Other Intervention Name(s)
counseling and communications studies
Intervention Description
Receive counseling sessions with a patient navigator
Intervention Type
Procedure
Intervention Name(s)
standard follow-up care
Intervention Description
Receive standard follow-up care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Proportion of BCS accessing a SCP from their oncology provider
Description
Fisher's exact test will be used to test the null hypothesis (at least 40% of trial participants will have access to SCP).
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Adherence to SCP guidelines
Description
Fisher's exact test will be used to test the null hypothesis (at least 25% of participants reporting adherence to SCP guidelines).
Time Frame
At 12 months
Title
Proportion of BCS accessing a SCP from their oncology provider
Description
Fisher's exact test will be used to test the null hypothesis (at least 60% of trial participants will have access to SCP).
Time Frame
At 12 months
Other Pre-specified Outcome Measures:
Title
Develop a clinically and psychosocially responsive SCP-BCS template in English and a linguistically response bilingual version (English-Spanish)
Description
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.
Time Frame
Up to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimlin Ashing-Giwa
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
City of Hope Antelope Valley
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs