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

Mayo Clinic

Status

Completed

Conditions

Malignant Neoplasm

Treatments

Procedure: standard follow-up care

Other: questionnaire administration

Behavioral: telephone-based intervention

Other: educational intervention

Procedure: quality-of-life assessment

Behavioral: exercise intervention

Other: counseling intervention

Study type

Observational

Funder types

Other

Identifiers

NCT01360814

2314-04 (Other Identifier)

MC0491 (Other Identifier)

NCI-2011-00670 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

138 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

138 participants in 2 patient groups

GROUP A (multidisciplinary intervention)

Description:

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.

Treatment: