Mood, Stress, Psychological
Conditions
Keywords
Stress management, Coping skills, Recently diagnosed cancer patients, Intervention, Psychological
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.
Interventions
BEHAVIORALFrom Cancer to Health (C2H-D)
From Cancer to Health gives people with cancer the information and tools they need to manage their stress to improve their health throughout the cancer journey. Each institution involved in this study will implement the core techniques of the C2H-D Intervention but may alter the format somewhat to meet their patient population needs (e.g., shorten hourly 18 week intervention into 2-hour 9 week intervention).
Sponsors
National Cancer Institute (NCI)
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to post-intensive intervention assessment in mood on the 65-item Profile of Mood States (POMS) | Baseline, up to 18 weeks | The intensive intervention length can vary by location from 4 to 18 weeks. |
| Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES) | Baseline, up to 18 weeks | The intensive intervention length can vary by location from 4 to 18 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to post-intensive intervention assessment in sexual health on the 4-item Your Sexual Life questionnaire | Baseline, up to 18 weeks | The intensive intervention length can vary by location from 4 to 18 weeks. |
| Change from baseline to post-intensive intervention assessment in diet on the 23-item Food Habits Questionnaire (FHQ) | Baseline, up to 18 weeks | The intensive intervention length can vary by location from 4 to 18 weeks. |
| Change from baseline to post-intensive intervention assessment in social support using the 20 item Perceived Social Support from Your Family Scale (PSS-Fa) | Baseline, up to 18 weeks | The intensive intervention length can vary by location from 4 to 18 weeks. |
| Change from baseline to post-intensive intervention assessment in physical activity on the 3-item Physical Activity Rating Scale (PAR) | Baseline, up to 18 weeks | The intensive intervention length can vary by location from 4 to 18 weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to post-intensive intervention assessment in fatigue using the 7-item Fatigue Severity Index (FSI) | Baseline, up to 18 weeks | The intensive intervention length can vary by location from 4 to 18 weeks. |
| Change from baseline to post-intensive intervention assessment in pain using the 13-item Brief Pain Questionnaire (BPQ) | Baseline, up to 18 weeks | The intensive intervention length can vary by location from 4 to 18 weeks. |
| Change from baseline to post-intensive intervention assessment in sleep using the 24-item Pittsburgh Sleep Quality Index (PSQI) | Baseline, up to 18 weeks | The intensive intervention length can vary by location from 4 to 18 weeks. |
Countries
United States
Outcome results
None listed