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Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors

Primary Purpose

Breast Carcinoma, Cancer Survivor, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Management of Therapy Complications
Quality-of-Life Assessment
Questionnaire Administration
Telephone-Based Intervention
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Carcinoma

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center
  • University of Colorado Cancer Center - Anschutz Cancer Pavilion
  • Dana-Farber Cancer Institute
  • UNC Lineberger Comprehensive Cancer Center
  • University of Pennsylvania/Abramson Cancer Center
  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm I (usual care)

Arm II (survivorship care)

Arm Description

Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in 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.

Outcomes

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
July 15, 2014
Last Updated
October 8, 2020
Sponsor
Fred Hutchinson Cancer Center
Collaborators
Livestrong Foundation, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02192333
Brief Title
Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors
Official Title
Young Adult Cancer Survivor Network Study of the Essential Elements of Care (YA-EEC-14)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 3, 2015 (Actual)
Primary Completion Date
October 7, 2017 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
Livestrong Foundation, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (usual care)
Arm Type
No Intervention
Arm Description
Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II.
Arm Title
Arm II (survivorship care)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Management of Therapy Complications
Intervention Description
Receive survivorship care
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Receive phone-based booster intervention
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Barriers to health care assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Change in depression assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Baseline to up to 12 months
Title
Change in distress assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Baseline to up to 12 months
Title
Change in fatigue assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Baseline to up to 12 months
Title
Change in pain assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Baseline to up to 12 months
Title
Change in sleep assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Baseline to up to 12 months
Title
Confidence in survivorship information assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
General health assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Health behaviors assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Health care utilization assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Medications assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Mood and worries assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Musculoskeletal symptoms assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Neuropathy assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Post-traumatic stress assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Quality of life assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Reclassification of subject from high need to low need
Description
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.
Time Frame
At 6 months
Title
Reproductive health assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Sexual function assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months
Title
Social support assessed using the patient-reported outcomes (PRO) survey
Description
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.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K. Scott Baker
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Colorado Cancer Center - Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34590205
Citation
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.
Results Reference
derived

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Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors

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