Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors

Depression Clinical Trial

Official title:

Young Adult Cancer Survivor Network Study of the Essential Elements of Care (YA-EEC-14)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192333
• Other study ID #: 9161
• Secondary ID: NCI-2014-0132591
• Status: Completed
• Phase: N/A
• Start date: August 3, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: December 31, 2019
• Est. primary completion date: October 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasms
• Breast Carcinoma
• Breast Neoplasms
• Cancer Survivor
• Depression
• Digestive System Neoplasms
• Fatigue
• Gastrointestinal Neoplasms
• Genital Neoplasms, Female
• Genital Neoplasms, Male
• Leukemia
• Lymphoma
• Malignant Bone Neoplasm
• Malignant Digestive System Neoplasm
• Malignant Female Reproductive System Neoplasm
• Malignant Male Reproductive System Neoplasm
• Neoplasms
• Pain
• Sarcoma
• Sleep Disorder
• Sleep Wake Disorders
• Soft Tissue Sarcoma

Intervention

Procedure:
• Management of Therapy Complications
Receive survivorship care

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive phone-based booster intervention

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center - Anschutz Cancer Pavilion	Aurora	Colorado
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California
United States	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Livestrong Foundation, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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