NCT01360814

Structured Multidisciplinary Intervention or Standard Medical Care in Improving Quality of Life in Patients Receiving Active Cancer Treatment

A Structured Multidisciplinary Intervention to Improve Quality of Life of Patients Receiving Active Oncological Treatment: A Randomized Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 138 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial studies structured multidisciplinary intervention or standard medical care in improving quality of life (QOL) in patients receiving active cancer treatment. A structured multidisciplinary intervention may improve the QOL in patients receiving treatment for cancer. It is not yet known whether structured multidisciplinary intervention is more effective than standard medical care in improving QOL

Detailed description

PRIMARY OBJECTIVES: I. To examine the efficacy of a structured multidisciplinary intervention compared to standard medical care on improving the subject's QOL as measured by the Functional Assessment of Cancer Therapy-General global summary score (FACT-G) at 4 weeks (or at end of the intervention), at 27 weeks and at 52 weeks. SECONDARY OBJECTIVES: I. To examine the effect of a structured multidisciplinary intervention compared to standard medical care on improving the subject's psychosocial functioning as measured by the 11 Linear Analogue Self Assessment (LASA) QOL scales, Profile of Mood States (POMS), the Functional Assessment of Chronic Illness Therapy-Spiritual well-being scale (FACIT-SP), Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Control Preferences Scale, and Exercise Behaviors at 4 weeks (or at end of intervention), at 27 weeks and at 52 weeks. II. To examine the effect of a structured multidisciplinary intervention compared to standard medical care on improving the caregiver's QOL as measured by the Caregiver QOL-Cancer scale, and on their psychosocial functioning as measured by the 11 LASA QOL scales and POMS at 4, 27 and 52 weeks. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP A: Patients receive six 90-minute sessions of multidisciplinary structured intervention comprising physical therapy, education, a cognitive-behavioral intervention, discussion and support, spiritual reflection, and a relaxation exercise over 2-4 weeks. Caregivers are invited to sessions 1, 3, 4, and 6. Patients may also receive brief telephone contact during the 6 month follow-up period. GROUP B: Patients receive standard medical care only. Patients may also receive brief telephone contact during the 6 month follow-up period. After completion of study treatment, patients are followed up at 4 weeks (or at the end of intervention), at 27 weeks, and at 52 weeks.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
PROCEDURE	quality-of-life assessment	Ancillary studies
BEHAVIORAL	telephone-based intervention	Receive multidisciplinary structured intervention
OTHER	questionnaire administration	Ancillary studies
OTHER	counseling intervention	Receive multidisciplinary structured intervention
BEHAVIORAL	exercise intervention	Receive multidisciplinary structured intervention
OTHER	educational intervention	Receive multidisciplinary structured intervention
BEHAVIORAL	telephone-based intervention	Receive standard care
PROCEDURE	standard follow-up care	Receive standard care

Timeline

• Start date: 2005-01-01
• Primary completion: 2009-03-13
• Completion: 2018-07-02
• First posted: 2011-05-26
• Last updated: 2019-12-18

Locations

1 site across 1 country: United States