Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Chronic Pain, Depression, Depression, Insomnia Sleep Studies, Other Indications, Blood Cancer, Lymphoma, Leukemia
Therapuetic Areas:Musculoskeletal, Oncology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 39
Updated:11/16/2018
Start Date:August 3, 2015
End Date:December 31, 2023

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Young Adult Cancer Survivor Network Study of the Essential Elements of Care (YA-EEC-14)

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.

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.

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
We found this trial at
6
sites
Seattle, Washington 98109
Principal Investigator: K. S. Baker
Phone: 206-667-5594
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13001 E. 17th Pl.
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Linda Overholser
Phone: 303-724-6348
University of Colorado Cancer Center - Anschutz Cancer Pavilion The University of Colorado Denver |...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Chapel Hill, North Carolina 27599
Principal Investigator: Donald L. Rosenstein
Phone: 919-843-8895
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Los Angeles, California 90095
Principal Investigator: Patricia A. Ganz
Phone: 310-825-9781
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Los Angeles, CA
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Philadelphia, Pennsylvania 19104
Principal Investigator: Linda Jacobs
Phone: 215-615-3371
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Philadelphia, PA
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