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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source | |
| RG1001123 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| Livestrong Foundation | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (usual care) | No Intervention | Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II. | |
| Arm II (survivorship care) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Management of Therapy Complications | Procedure | Receive survivorship care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in depression assessed using the patient-reported outcomes (PRO) survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| K. Scott Baker | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States | ||
| University of Colorado Cancer Center - Anschutz Cancer Pavilion |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36779982 | Derived | Hall AG, Syrjala KL, Ketterl TG, Ganz PA, Jacobs LA, Palmer SC, Partridge A, Rajotte EJ, Mueller BA, Baker KS. Socioeconomic Factors and Adherence to Health Care Recommendations in Adolescent and Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2023 Oct;12(5):701-709. doi: 10.1089/jayao.2022.0109. Epub 2023 Feb 13. | |
| 34590205 | Derived | 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. |
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| Quality-of-Life Assessment |
| Other |
Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Telephone-Based Intervention | Behavioral | Receive phone-based booster intervention |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| D005221 | Fatigue |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D001859 | Bone Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D010146 | Pain |
| D012893 | Sleep Wake Disorders |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D018204 | Neoplasms, Connective and Soft Tissue |
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