Clinical trial NCT01824745: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Cancer Survivor
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-04-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Proportion of BCS accessing a SCP from their oncology provider
timeFrame: At 6 months
Secondary outcomes:
measure: Adherence to SCP guidelines
timeFrame: At 12 months
measure: Proportion of BCS accessing a SCP from their oncology provider
timeFrame: At 12 months
Other outcomes:
measure: Develop a clinically and psychosocially responsive SCP-BCS template in English and a linguistically response bilingual version (English-Spanish)
timeFrame: Up to 12 months
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Lancaster
country: United States
facility: City of Hope Antelope Valley
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Kimlin Ashing-Giwa
role: PRINCIPAL_INVESTIGATOR
References: