NCT02192333

Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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. 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

• Breast Carcinoma
• Cancer Survivor
• Depression
• Fatigue
• Leukemia
• Lymphoma
• Malignant Bone Neoplasm
• Malignant Digestive System Neoplasm
• Malignant Female Reproductive System Neoplasm
• Malignant Male Reproductive System Neoplasm
• Pain
• Sleep Disorder
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
PROCEDURE	Management of Therapy Complications	Receive survivorship care
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
BEHAVIORAL	Telephone-Based Intervention	Receive phone-based booster intervention

Timeline

• Start date: 2015-08-03
• Primary completion: 2017-10-07
• Completion: 2019-12-31
• First posted: 2014-07-16
• Last updated: 2020-10-09

Locations

6 sites across 1 country: United States