Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors

NCT02192333 | Completed

• 4 other identifiers: 9161NCI-2014-01325P30CA015704RG1001123
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Barriers to health care assessed using the patient-reported outcomes (PRO) survey

  Up to 12 months

• Change in depression assessed using the patient-reported outcomes (PRO) survey

  Baseline to up to 12 months

• Change in distress assessed using the patient-reported outcomes (PRO) survey

  Baseline to up to 12 months

• Change in fatigue assessed using the patient-reported outcomes (PRO) survey

  Baseline to up to 12 months

• Change in pain assessed using the patient-reported outcomes (PRO) survey

  Baseline to up to 12 months

Study Arms (2)

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.

Procedure: Management of Therapy Complications; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

Interventions

Management of Therapy Complications PROCEDURE

Receive survivorship care

Arm II (survivorship care)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm II (survivorship care)

Questionnaire Administration OTHER

Ancillary studies

Arm II (survivorship care)

Telephone-Based Intervention BEHAVIORAL

Receive phone-based booster intervention

Arm II (survivorship care)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Prior visit to a survivorship clinic or previously provided with a treatment summary and care plan

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Livestrong Foundation: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (6)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (2)

• 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.

  PMID: 36779982 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.

  PMID: 34590205 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Depression; Fatigue; Leukemia; Lymphoma; Bone Neoplasms; Gastrointestinal Neoplasms; Pain; Sleep Wake Disorders; Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Diseases; Musculoskeletal Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neoplasms, Connective and Soft Tissue

Study Officials

• K. Scott Baker

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 16, 2014
• Study Start: August 3, 2015
• Primary Completion: October 7, 2017
• Study Completion: December 31, 2019
• Last Updated: October 9, 2020

Record last verified: 2020-10

Locations

US (6)