Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

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

Treatments: Behavioral: Telephone-Based Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Procedure: Management of Therapy Complications

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02192333

NCI-2014-01325 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

RG1001123 (Other Identifier)

9161 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 390 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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390 participants in 2 patient groups

Arm I (usual care)

No Intervention group

Description:

Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II.

Arm II (survivorship care)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Behavioral: Telephone-Based Intervention

Other: Quality-of-Life Assessment

Procedure: Management of Therapy Complications