Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT02192333

Collaborator

Livestrong Foundation (Other), National Cancer Institute (NCI) (NIH)

390

Enrollment

Locations

Arms

52.9

Actual Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Detailed Description

PRIMARY OBJECTIVES:

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:

To improve confidence in survivorship knowledge and promote healthy lifestyle behaviors.
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 Design

Study Type:

Interventional

Actual Enrollment :

390 participants

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)

Actual Study Start Date :

Aug 3, 2015

Actual Primary Completion Date :

Oct 7, 2017

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

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.	Procedure: Management of Therapy Complications Receive survivorship care Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Behavioral: Telephone-Based Intervention Receive phone-based booster intervention

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.

Procedure: Management of Therapy Complications

Receive survivorship care

Other: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Other: Questionnaire Administration

Ancillary studies

Behavioral: Telephone-Based Intervention

Receive phone-based booster intervention

Outcome Measures

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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California	United States	90095
2	University of Colorado Cancer Center - Anschutz Cancer Pavilion	Aurora	Colorado	United States	80045
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
4	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	United States	27599
5	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania	United States	19104
6	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington	United States	98109