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)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Soft Tissue Sarcoma; Pain; Lymphoma; Leukemia; Fatigue; Sleep Disorder; Breast Carcinoma; Cancer Survivor; Malignant Female Reproductive System Neoplasm; Malignant Digestive System Neoplasm; Malignant Male Reproductive System Neoplasm; Malignant Bone Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Management of Therapy Complications; Behavioral: Telephone-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center - Anschutz Cancer Pavilion
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Lineberger Comprehensive Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania/Abramson Cancer Center
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm I (usual care); Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II.
Experimental: 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Management of Therapy Complications; Receive survivorship care; Behavioral: Telephone-Based Intervention; Receive phone-based booster intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to health care 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.	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.	Baseline to up to 12 months
Change in distress 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.	Baseline to up to 12 months
Change in fatigue 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.	Baseline to up to 12 months
Change in pain 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.	Baseline to up to 12 months
Change in sleep 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.	Baseline to up to 12 months
Confidence in survivorship information 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.	Up to 12 months
General health 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.	Up to 12 months
Health behaviors 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.	Up to 12 months
Health care utilization 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.	Up to 12 months
Medications 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.	Up to 12 months
Mood and worries 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.	Up to 12 months
Musculoskeletal symptoms 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.	Up to 12 months
Neuropathy 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.	Up to 12 months
Post-traumatic stress 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.	Up to 12 months
Quality of life 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.	Up to 12 months
Reclassification of subject from high need to low need	Reclassification of subject from high need to low need is defined as the high need subject no longer has scores above the cut-off level on 2 or more symptoms scales (depression, distress, insomnia, fatigue, pain) assessed using the PRO survey. The 5 symptom scales are categorized based on the following cut points to define "high need": pain score >= 5, fatigue score >= 3, insomnia score of no insomnia, distress score > 1.1, and depression score >= 10.	At 6 months
Reproductive health 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.	Up to 12 months
Sexual function 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.	Up to 12 months
Social support 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.	Up to 12 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); Livestrong Foundation
• Investigators: Principal Investigator: K. Scott Baker, Fred Hutch/University of Washington Cancer Consortium

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2015
• Primary Completion (Actual): October 7, 2017
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Nervous System Diseases; Skin Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Neurologic Manifestations; Gastrointestinal Diseases; Breast Diseases; Musculoskeletal Diseases; Bone Diseases; Neoplasms; Sarcoma; Breast Neoplasms; Sleep Wake Disorders; Bone Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Genital Neoplasms, Female; Genital Neoplasms, Male
• Other Study ID Numbers: 9161 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); NCI-2014-01325 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); RG1001123 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)