Clinical trial NCT02070250: Stress Management for Cancer Patients: How Well Does it Work? (C2H-D)
Official title: Examination of a Stress Management Intervention for Cancer Patients as Delivered by Community Mental Health Professionals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood
Stress, Psychological
Keywords: Stress management
Coping skills
Recently diagnosed cancer patients
Intervention, Psychological
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-25
Enrollment: 158
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Psychological interventions for cancer patients have been tested and found to reduce stress and improve quality of life. These interventions have been tested at academic medical centers but have not been available for use by community mental health professionals. One such intervention is the Biobehavioral Intervention (BBI), developed by Professor Barbara L. Andersen and colleagues at Ohio State (OSU). Current funding has enabled the investigators to train mental health professionals from across the country to deliver the BBI at their institution. Recently diagnosed cancer patients who are participating in the BBI group at these institutions may participate in a research study completing self report measures asking about psychological and behavioral outcomes (for example, mood, stress, diet and physical activity). The investigators hypothesize that individuals participating in the intervention will report improvements in outcomes, such as reduced stress and improved mood, reduced symptoms of the disease and treatment, etc., after completing the intervention and continue to report these improvements up to 6 months after the group ends. OSU will coordinate this data collection project but information about participating sites is listed in http://clinicaltrials.gov.


Eligibility criteria: Inclusion Criteria:

* Recent initial diagnosis of cancer without metastatic disease
* Able to speak/read English

Exclusion Criteria: Those with concurrent diagnoses of

* Organic brain syndrome
* Dementia
* Mental retardation
* non-English speaking
* Significant sensory deficit
* Severe mental illness (e.g., schizophrenia, psychotic disorder)

Primary outcomes:
measure: Change from baseline to post-intensive intervention assessment in mood on the 65-item Profile of Mood States (POMS)
timeFrame: Baseline, up to 18 weeks
measure: Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES)
timeFrame: Baseline, up to 18 weeks
Secondary outcomes:
measure: Change from baseline to post-intensive intervention assessment in social support using the 20 item Perceived Social Support from Your Family Scale (PSS-Fa)
timeFrame: Baseline, up to 18 weeks
measure: Change from baseline to post-intensive intervention assessment in physical activity on the 3-item Physical Activity Rating Scale (PAR)
timeFrame: Baseline, up to 18 weeks
measure: Change from baseline to post-intensive intervention assessment in diet on the 23-item Food Habits Questionnaire (FHQ)
timeFrame: Baseline, up to 18 weeks
measure: Change from baseline to post-intensive intervention assessment in sexual health on the 4-item Your Sexual Life questionnaire
timeFrame: Baseline, up to 18 weeks
Other outcomes:
measure: Change from baseline to post-intensive intervention assessment in pain using the 13-item Brief Pain Questionnaire (BPQ)
timeFrame: Baseline, up to 18 weeks
measure: Change from baseline to post-intensive intervention assessment in fatigue using the 7-item Fatigue Severity Index (FSI)
timeFrame: Baseline, up to 18 weeks
measure: Change from baseline to post-intensive intervention assessment in sleep using the 24-item Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, up to 18 weeks
Locations:
city: Auburn
country: United States
facility: Cancer Center of East Alabama Medical Center
state: Alabama
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Santa Monica
country: United States
facility: Providence Saint John's Health Center
state: California
city: Truckee
country: United States
facility: Tahoe Forest Cancer Center
state: California
city: Hinsdale
country: United States
facility: Wellness House
state: Illinois
city: Northbrook
country: United States
facility: Cancer Wellness Center
state: Illinois
city: Muncie
country: United States
facility: IU Health Ball Memorial Hospital
state: Indiana
city: Davenport
country: United States
facility: Genesis Health Center
state: Iowa
city: Davenport
country: United States
facility: Unity Point Health/Gilda's Club Quad Cities
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Columbus
country: United States
facility: OSU Stephanie Spielman Comprehensive Breast Center
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Seton UT Southwestern
state: Texas
city: Plano
country: United States
facility: Baylor Regional Medical Center at Plano, Texas
state: Texas
Study officials:
affiliation: Ohio State University
name: Barbara L Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashmore JA, Ditterich KW, Conley CC, Wright MR, Howland PS, Huggins KL, Cooreman J, Andrews PS, Nicholas DR, Roberts L, Hewitt L, Scales JN, Delap JK, Gray CA, Tyler LA, Collins C, Whiting CM, Brothers BM, Ryba MM, Andersen BL. Evaluating the effectiveness and implementation of evidence-based treatment: A multisite hybrid design. Am Psychol. 2019 May-Jun;74(4):459-473. doi: 10.1037/amp0000309. Epub 2018 Jul 19.