Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors

N/ACompletedNCT02192333

Fred Hutchinson Cancer Center390 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

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

Locations (6)

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

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

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.

Time frame: At 6 months

Secondary Outcomes

Barriers to health care assessed using the patient-reported outcomes (PRO) survey

Time frame: Up to 12 months

Change in depression assessed using the patient-reported outcomes (PRO) survey

Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.