Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT02192333
First received: July 15, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  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
Bone Cancer
Breast Cancer
Cancer Survivor
Depression
Fatigue
Female Reproductive Cancer
Gastrointestinal Cancer
Leukemia
Lymphoma
Male Reproductive Cancer
Pain
Sleep Disorders
Soft Tissue Sarcoma
Procedure: management of therapy complications
Behavioral: telephone-based intervention
Other: questionnaire administration
Other: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: LIVESTRONG 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 PRO survey [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    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:
  • Reclassification of subject from high need to low need, 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 [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    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.

  • Confidence in survivorship information assessed using the PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Barriers to health care assessed using the PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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.

  • Reproductive health assessed using the PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 pain assessed using the PRO survey [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
    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 PRO survey [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
    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 depression assessed using the PRO survey [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 455
Study Start Date: July 2014
Estimated Primary Completion Date: December 2015 (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 4-6 weeks and 12-14 weeks after the initial clinic visit.
Procedure: management of therapy complications
Receive survivorship care
Other Name: complications of therapy, management of
Behavioral: telephone-based intervention
Receive phone-based booster intervention
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

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 4-6 weeks and 12-14 weeks after the initial clinic visit.

After completion of study, participants are followed up at 6 and 12 months.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis 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 LIVESTRONG 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 2 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
  • Patients enrolled on Phase 1 of the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02192333

Locations
United States, California
Jonsson Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Patricia A. Ganz    310-825-9781      
Principal Investigator: Patricia A. Ganz         
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Linda Overholser    303-724-6348      
Principal Investigator: Linda Overholser         
United States, Massachusetts
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Ann H. Partridge    617-632-4587      
Principal Investigator: Ann H. Partridge         
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Donald L. Rosenstein    919-843-8895      
Principal Investigator: Donald L. Rosenstein         
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Linda Jacobs    215-615-3371      
Principal Investigator: Linda Jacobs         
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Not yet recruiting
Seattle, Washington, United States, 98109
Contact: K. S. Baker    206-667-5594      
Principal Investigator: K. S. Baker         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: K. Baker Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT02192333     History of Changes
Other Study ID Numbers: 9161, NCI-2014-01325, YA-EEC-14, 9161, P30CA015704
Study First Received: July 15, 2014
Last Updated: July 15, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Gastrointestinal Neoplasms
Parasomnias
Sarcoma
Sleep Disorders
Behavioral Symptoms
Breast Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Mental Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014