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Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02192333
First Posted: July 16, 2014
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Livestrong Foundation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Young Adult Cancer Survivor Network Study of the Essential Elements of Care (YA-EEC-14)

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 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 [ Time Frame: At 6 months ]
    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.


Secondary Outcome Measures:
  • Barriers to health care assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Change in depression assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Baseline to up to 12 months ]
    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.

  • Change in distress assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Baseline to up to 12 months ]
    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.

  • Change in fatigue assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Baseline to up to 12 months ]
    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.

  • Change in pain assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Baseline to up to 12 months ]
    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.

  • Change in sleep assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Baseline to up to 12 months ]
    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.

  • Confidence in survivorship information assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • General health assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Health behaviors assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Health care utilization assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Medications assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Mood and worries assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Musculoskeletal symptoms assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Neuropathy assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Post-traumatic stress assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Quality of life assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Reclassification of subject from high need to low need [ Time Frame: At 6 months ]
    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.

  • Reproductive health assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Sexual function assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.

  • Social support assessed using the patient-reported outcomes (PRO) survey [ Time Frame: Up to 12 months ]
    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.


Estimated Enrollment: 455
Actual Study Start Date: August 3, 2015
Estimated Study Completion Date: October 7, 2018
Primary Completion Date: October 7, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Management of Therapy Complications
Receive survivorship care
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Behavioral: Telephone-Based Intervention
Receive phone-based booster 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192333


Locations
United States, California
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Livestrong Foundation
National Cancer Institute (NCI)
Investigators
Principal Investigator: K. Scott Baker Fred Hutch/University of Washington Cancer Consortium
  More Information

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT02192333     History of Changes
Other Study ID Numbers: 9161
NCI-2014-01325 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9161 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: July 15, 2014
First Posted: July 16, 2014
Last Update Posted: October 17, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Neoplasms
Fatigue
Sarcoma
Breast Neoplasms
Sleep Wake Disorders
Parasomnias
Digestive System Neoplasms
Gastrointestinal Neoplasms
Bone Neoplasms
Genital Neoplasms, Female
Genital Neoplasms, Male
Signs and Symptoms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Digestive System Diseases
Gastrointestinal Diseases
Bone Diseases
Musculoskeletal Diseases
Urogenital Neoplasms
Genital Diseases, Male