Breast Cancer Clinical Trial
Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors
Summary
This randomized clinical trial studies survivorship care in reducing symptoms in young adult cancer survivors. Survivorship care programs that identify the needs of young adult cancer survivors and ways to support them through the years after treatment may help reduce symptoms, such as pain, fatigue, sleep disturbance, depression, and distress, in young adult cancer survivors.
Full Description
PRIMARY OBJECTIVES:
I. To test the impact of providing the essential elements of survivorship care on survivorship outcomes as indicated by reduction in symptoms (pain, fatigue, sleep disturbance, depression, distress) in young adult cancer survivors diagnosed with cancer between the ages of 18 and 39 years when compared with usual care.
SECONDARY OBJECTIVES:
I. To improve confidence in survivorship knowledge and promote healthy lifestyle behaviors.
II. To provide evidence on barriers, needs and care preferences that will support long term follow-up recommendations for this population.
OUTLINE: Participants categorized as high-need are randomized to 1 of 2 arms. Participants categorized as low-need are assigned to Arm I.
ARM I: Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II.
ARM II: Participants attend a survivorship clinic visit that includes care plans, screening recommendations, physician coordination, health promotion education, symptom management and palliative care, late effects education, psychosocial and medical assessments, and referrals for services and care as appropriate. Participants also receive phone-based survivorship boosters over approximately 15-30 minutes at 4-8 weeks and 12-16 weeks after the initial clinic visit.
After completion of study, participants are followed up at 6 and 12 months.
Eligibility Criteria
Inclusion Criteria:
Patients enrolled on phase 1 of the study are eligible (and/or if recruited from tumor registry or clinic follow-up schedules)
Diagnosed with invasive malignancy including: breast, gastrointestinal track, female or male genitourinary system, sarcoma of bone or soft-tissue, leukemia and lymphoma
Treated at one of the Survivorship Centers of Excellence or their community affiliates
Received a therapeutic intervention with at least one of the following modalities: surgery, cytotoxic chemotherapy, biological or targeted agents, radiation therapy (any modality)
Currently between 1.0 and 4.99 years from the completion of active cancer-directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention)
Patient must still be in active follow-up: seen for a follow-up visit in the participating center at least once in the 3 years prior to enrollment and/or scheduled to be seen for follow-up in the next 6 months (i.e. in active follow-up)
May be receiving "maintenance" therapy that has a goal of prevention of recurrence but there should be no expectations for further active treatment
Able to read and speak English adequate to complete the patient-reported outcomes (PRO) assessment
Exclusion Criteria:
Prior visit to a survivorship clinic or previously provided with a treatment summary and care plan
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There are 6 Locations for this study
Los Angeles California, 90095, United States
Aurora Colorado, 80045, United States
Boston Massachusetts, 02215, United States
Chapel Hill North Carolina, 27599, United States
Philadelphia Pennsylvania, 19104, United States
Seattle Washington, 98109, United States
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