Young Adult Cancer Survivor Network Study of the Essential Elements of Care (YA-EEC-14)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 390
- Locations
- 12
- Primary Endpoint
- Mean of the two z scores of the two highest scores for the symptoms that determined the participant's eligibility as "high need" assessed using patient-reported outcomes (PRO) survey
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Mean of the two z scores of the two highest scores for the symptoms that determined the participant's eligibility as "high need" assessed using patient-reported outcomes (PRO) survey
Time Frame: At 6 months
Mean scores for the primary outcome measures will be compared between the study using standard methods. Two-sided significance levels will be set at an alpha level of 0.05.
Secondary Outcomes
- Health behaviors assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Health care utilization assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Barriers to health care assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Change in depression assessed using the patient-reported outcomes (PRO) survey(Baseline to up to 12 months)
- Change in pain assessed using the patient-reported outcomes (PRO) survey(Baseline to up to 12 months)
- Change in sleep assessed using the patient-reported outcomes (PRO) survey(Baseline to up to 12 months)
- Confidence in survivorship information assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Medications assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Mood and worries assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Musculoskeletal symptoms assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Reclassification of subject from high need to low need(At 6 months)
- Change in distress assessed using the patient-reported outcomes (PRO) survey(Baseline to up to 12 months)
- Change in fatigue assessed using the patient-reported outcomes (PRO) survey(Baseline to up to 12 months)
- General health assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Sexual function assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Social support assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Neuropathy assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Post-traumatic stress assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Quality of life assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)
- Reproductive health assessed using the patient-reported outcomes (PRO) survey(Up to 12 months)