Stress Management for Cancer Patients: How Well Does it Work? (C2H-D)

Study Overview
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Brief Summary
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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.

Official Title
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Examination of a Stress Management Intervention for Cancer Patients as Delivered by Community Mental Health Professionals

Conditions
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Mood, Stress, Psychological

Intervention / Treatment
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* Behavioral: From Cancer to Health (C2H-D)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: From Cancer to Health (C2H-D)<br>Individuals participating in the From Cancer to Health (C2H-D) Stress Management Psychological Intervention | Behavioral: From Cancer to Health (C2H-D)<br>* 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).<br>* Other names: Stress management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to post-intensive intervention assessment in mood on the 65-item Profile of Mood States (POMS) | The intensive intervention length can vary by location from 4 to 18 weeks. | Baseline, up to 18 weeks | 
| Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES) | The intensive intervention length can vary by location from 4 to 18 weeks. | Baseline, up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to post-intensive intervention assessment in social support using the 20 item Perceived Social Support from Your Family Scale (PSS-Fa) | The intensive intervention length can vary by location from 4 to 18 weeks. | Baseline, up to 18 weeks | 
| Change from baseline to post-intensive intervention assessment in physical activity on the 3-item Physical Activity Rating Scale (PAR) | The intensive intervention length can vary by location from 4 to 18 weeks. | Baseline, up to 18 weeks | 
| Change from baseline to post-intensive intervention assessment in diet on the 23-item Food Habits Questionnaire (FHQ) | The intensive intervention length can vary by location from 4 to 18 weeks. | Baseline, up to 18 weeks | 
| Change from baseline to post-intensive intervention assessment in sexual health on the 4-item Your Sexual Life questionnaire | The intensive intervention length can vary by location from 4 to 18 weeks. | Baseline, up to 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress management, Coping skills, Recently diagnosed cancer patients, Intervention, Psychological