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

City of Hope

Status: Active, not recruiting

Conditions: Breast Cancer; Cancer Survivor

Treatments: Procedure: standard follow-up care; Procedure: quality-of-life assessment; Other: counseling intervention; Other: questionnaire administration; Other: educational intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01824745

NCI-2013-00734 (Registry Identifier)

12383

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Arm I (SCP-BCS template booklet and counseling)

Experimental group

Description:

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

Treatment:

Other: educational intervention

Other: questionnaire administration

Procedure: quality-of-life assessment

Other: counseling intervention

Arm II (SCP-BCS template booklet)

Active Comparator group

Description:

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

Treatment:

Other: educational intervention

Other: questionnaire administration

Procedure: quality-of-life assessment

Procedure: standard follow-up care