Clinical trial NCT01360814: Structured Multidisciplinary Intervention or Standard Medical Care in Improving Quality of Life in Patients Receiving Active Cancer Treatment
Official title: A Structured Multidisciplinary Intervention to Improve Quality of Life of Patients Receiving Active Oncological Treatment: A Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cancer patient's quality of life (QOL) as measured by the FACT-G global summary score
timeFrame: At baseline and 4, 27, and 52 weeks
Secondary outcomes:
measure: 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
timeFrame: At baseline and 4, 27, and 52 weeks
measure: 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
timeFrame: At baseline and 4, 27 and 52 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Clark, Ph.D.
role: STUDY_CHAIR
References:
citation: Chock MM, Lapid MI, Atherton PJ, Kung S, Sloan JA, Richardson JW, Clark MM, Rummans TA. Impact of a structured multidisciplinary intervention on quality of life of older adults with advanced cancer. Int Psychogeriatr. 2013 Dec;25(12):2077-86. doi: 10.1017/S1041610213001452. Epub 2013 Sep 4.