Clinical trial NCT02192333: Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors
Official title: Young Adult Cancer Survivor Network Study of the Essential Elements of Care (YA-EEC-14)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Livestrong Foundation
name: National Cancer Institute (NCI)
First posted: 2014-07-16
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At 6 months
Secondary outcomes:
measure: Barriers to health care assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Change in depression assessed using the patient-reported outcomes (PRO) survey
timeFrame: Baseline to up to 12 months
measure: Change in distress assessed using the patient-reported outcomes (PRO) survey
timeFrame: Baseline to up to 12 months
measure: Change in fatigue assessed using the patient-reported outcomes (PRO) survey
timeFrame: Baseline to up to 12 months
measure: Change in pain assessed using the patient-reported outcomes (PRO) survey
timeFrame: Baseline to up to 12 months
measure: Change in sleep assessed using the patient-reported outcomes (PRO) survey
timeFrame: Baseline to up to 12 months
measure: Confidence in survivorship information assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: General health assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Health behaviors assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Health care utilization assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Medications assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Mood and worries assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Musculoskeletal symptoms assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Neuropathy assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Post-traumatic stress assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Quality of life assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Reclassification of subject from high need to low need
timeFrame: At 6 months
measure: Reproductive health assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Sexual function assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
measure: Social support assessed using the patient-reported outcomes (PRO) survey
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center - Anschutz Cancer Pavilion
state: Colorado
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: K. Scott Baker
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.