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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Procedure: quality-of-life assessment
* Behavioral: telephone-based intervention
* Other: questionnaire administration
* Other: counseling intervention
* Behavioral: exercise intervention
* Other: educational intervention
* Behavioral: telephone-based intervention
* Procedure: standard follow-up care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to attend all treatment sessions and follow-up Ability to provide written informed consent Ability to participate in all aspects of the study Initial diagnosis of cancer must have been =< 12 months prior to study entry Intermediate to poor prognosis, defined as an expected 5-year survival of 0-50% in the judgment of the physicians entering the patient on the study Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2 >= 1 week of planned cancer treatment at Mayo Clinic Has a caregiver also willing to participate Exclusion Criteria: Mini-mental state examination (MMSE) scores of < 20 Expected survival of < 6 months Active substance abuse (alcohol or drug) Participation in other psycho-social research trials Active thought disorder (bipolar illness, schizophrenia, etc.) Suicidal intent or plan In need of psychiatric hospitalization Recurrent disease after disease-free interval of > 6 months Previous cancer =< 5 years (except non-melanoma skin cancer and/or second cancer diagnosed at approximately the same time as this cancer)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GROUP A (multidisciplinary intervention)<br>Patients receive six 90-minute sessions of a 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. | Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Behavioral: telephone-based intervention<br>* Receive multidisciplinary structured intervention<br>Other: questionnaire administration<br>* Ancillary studies<br>Other: counseling intervention<br>* Receive multidisciplinary structured intervention<br>* Other names: counseling and communications studies;Behavioral: exercise intervention<br>* Receive multidisciplinary structured intervention<br>Other: educational intervention<br>* Receive multidisciplinary structured intervention<br>* Other names: intervention, educational;|
| GROUP B (standard medical care)<br>Patients receive standard medical care only. Patients may also receive brief telephone contact during the 6 month follow-up period. | Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>Behavioral: telephone-based intervention<br>* Receive standard care<br>Procedure: standard follow-up care<br>* Receive standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer patient's quality of life (QOL) as measured by the FACT-G global summary score | The t-test and Wilcoxon test supplemented by repeated measures analytical procedures (analysis of variance [ANOVA], Generalized Estimating Equations [GEE]) will be used to measure and analyze QOL. | At baseline and 4, 27, and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On improving the subject's psychosocial functioning as measured by the 11 LASA QOL scales, Profile of Mood States (POMS), the FACIT-SP, Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Control Preferences Scale, and Exercise Behaviors | The t-test and Wilcoxon test supplemented by repeated measures analytical procedures (analysis of variance [ANOVA], Generalized Estimating Equations [GEE]) will be used to measure and analyze. | At baseline and 4, 27, and 52 weeks | 
| On improving the caregiver's QOL as measured by the Caregiver QOLCancer scale, and on their psychosocial functioning as measured by the 11 LASA QOL scales and POMS | The t-test and Wilcoxon test supplemented by repeated measures analytical procedures (analysis of variance [ANOVA], Generalized Estimating Equations [GEE]) will be used to measure and analyze | At baseline and 4, 27 and 52 weeks |