Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors
NCT ID: NCT02192333
Last Updated: 2020-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
390 participants
INTERVENTIONAL
2015-08-03
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (usual care)
Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II.
No interventions assigned to this group
Arm II (survivorship care)
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.
Management of Therapy Complications
Receive survivorship care
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Receive phone-based booster intervention
Interventions
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Management of Therapy Complications
Receive survivorship care
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Receive phone-based booster intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
39 Years
ALL
No
Sponsors
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Livestrong Foundation
OTHER
National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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K. Scott Baker
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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References
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Hall AG, Syrjala KL, Ketterl TG, Ganz PA, Jacobs LA, Palmer SC, Partridge A, Rajotte EJ, Mueller BA, Baker KS. Socioeconomic Factors and Adherence to Health Care Recommendations in Adolescent and Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2023 Oct;12(5):701-709. doi: 10.1089/jayao.2022.0109. Epub 2023 Feb 13.
Syrjala KL, Walsh CA, Yi JC, Leisenring WM, Rajotte EJ, Voutsinas J, Ganz PA, Jacobs LA, Palmer SC, Partridge A, Baker KS. Cancer survivorship care for young adults: a risk-stratified, multicenter randomized controlled trial to improve symptoms. J Cancer Surviv. 2022 Oct;16(5):1149-1164. doi: 10.1007/s11764-021-01105-8. Epub 2021 Sep 29.
Other Identifiers
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NCI-2014-01325
Identifier Type: REGISTRY
Identifier Source: secondary_id
9161
Identifier Type: OTHER
Identifier Source: secondary_id
RG1001123
Identifier Type: OTHER
Identifier Source: secondary_id
9161
Identifier Type: -
Identifier Source: org_study_id
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