Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors

Status Completed

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.

Clinical Trial 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. ;

Study Design

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

Clinical Trial Details

NCT number	NCT02192333
Study type	Interventional
Source	Fred Hutchinson Cancer Research Center
Contact
Status	Completed
Phase	N/A
Start date	August 3, 2015
Completion date	December 31, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.