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Patients and caregivers are taught problem solving skills

Michael Carducci, M.D.

Betty Ferrell, Ph.D

Anthony Back, M.D.

Heinz Josef Lenz, M.D.

Joanne Mortimer, M.D.

Frederick J Meyers, MD

This is a multi-site randomized control trial taking place at six cancer centers. UC Davis is the lead site. Additional performance sites include the City of Hope Medical Center, Fred Hutchinson Cancer Center at the Univ. of Washington, USC Norris Cancer Center, UCSD Cancer Center, and Johns Hopkins Cancer Center. Clinical trial patients and their caregivers who are randomized to the intervention arm of the study are scheduled for three educational sessions. The sessions focus on teaching problem solving skills based on the COPE problem solving model.

The project introduces and evaluates the effects of a Simultaneous Care Education Intervention, using the COPE model (Creativity, Optimism, Planning and Expert Information) developed by D'Zurilla and Nezu, as one of its key components for cancer patients in Phase I, II and III clinical trials. The SCEI team will use the COPE problem solving educational model to instruct patients on how to problem solve and manage challenges associated not only with the investigational therapy, but also the psychosocial issues that arise from cancer diagnosis, disease progression, treatment, and disease or treatment related symptoms. The educational intervention also sets up a system for regularly contacting the patient and caregiver in order to reinforce what is taught. Patients and caregivers randomized to the intervention arm will receive three education sessions. Patients and designated caregiver will be asked to complete the set of measurement tools approximately every 30 days while enrolled in the study.

Simultaneous Care: Linking Palliation to Clinical Trials

A Randomized Control Trial That Teaches Oncology Clinical Trial Patients and Their Caregivers Problem Solving Skills.

University of California, Davis

Behaviors and Mental Disorders

Anxiety Disorders

Problem-Solving Skills Training

Olle Jane Z. Sahler, MD

Robert W Butler, PhD

Martha A Askins, PhD

Robert B Noll, PhD

Ernest R Katz, PhD

Donna R Copeland, PhD

Lewis W Johnson, PhD

The purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills.

The purpose of this study is:

1. to develop a time-and-attention control condition to better assess the direct and mediational effect of PSST independent of social support (placebo);
2. to develop a personal digital assistant hand-held supplement to standard PSST to provide real-time training, reinforcement, and on-the-spot documentation of PSST usage;
3. to develop independent measures of the application of problem-solving strategies in everyday life; and
4. to measure utilization of and satisfaction with other resources accessed by mothers as independent indicators of the usefulness and cost-effectiveness of PSST.

Maternal Problem-Solving in Childhood Cancer

National Institutes of Health (NIH)

University of Rochester

Professor

An online version of Problem-Solving Skills Training (PSST) will be compared to standard (face-to-face) PSST

This is an 8-session face-to-face Problem-Solving Skills Training intervention

8-session manualized intervention to provide problem-solving skills training in the context of childhood cancer.

Olle Jane Z Sahler, MD

Parents of children newly diagnosed with cancer experience depression and anxiety, especially in the first several months of treatment. Bright IDEAS, an 8-session problem-solving skills training (PSST) program has been used in studies with more than 900 mothers including more than 125 monolingual Spanish-speaking mothers. It has been shown to significantly decrease mothers' distress and to particularly benefit Latina immigrants. This past spring, the NCI/NIH designated Bright IDEAS as a Research-Tested Intervention Program and has included it in the National Registry of Evidence-based Programs and Practices. To date, Bright IDEAS has been available to mothers at only a few cancer centers with specially trained personnel. This proposal is designed to bring Bright IDEAS on-line to make it available to mothers and fathers 24/7 anywhere with Internet access. The investigators will carefully analyze acceptability and use to gain insight into the most promising ways of disseminating interventions like Bright IDEAS using Internet, Internet II, and other emerging technologies.

Research and experience document that caregivers of children with cancer encounter extraordinary stresses during the child's illness. These stresses are particularly severe during diagnosis and early therapy and can interfere significantly with a caregiver's ability to make reasoned and timely decisions on their child's behalf. With increasing survivor rates, it has become evident that decisions made in the early stages of cancer management can have profound long-term effects, adding to the distress caregivers feel trying to make the "right" decisions. Too help mothers of newly diagnosed children cope more effectively with these challenges, the investigators conducted randomized controlled trials (R25CA65520, R01CA098954) to develop, field test, and evaluate the efficacy of the Bright IDEAS paradigm of problem-solving skills training (PSST), a cognitive-behavioral therapy shown to decrease anxiety and depression - two symptoms of post-traumatic stress commonly experienced among this group of mothers. Our findings clearly show that PSST significantly increases problem-solving skills (primary effect) and decreases negative affectivity (secondary effect) in mothers from a variety of racial, ethnic, and socioeconomic backgrounds. Particularly powerful and long-lasting effects were noted in Spanish-speaking mothers, an especially underserved population. In March 2010, the NCI designated Bright IDEAS as a Research-based Therapy/Intervention Program (RTIP) and entered it into the National Registry of Evidence-based Programs and Practices (NREPP). As an 8-session, in-person intervention, Bright IDEAS is labor intensive and, to date, has only been available at a few institutions with trained personnel. However, as a part of the RTIPs evaluation process, the Dissemination Capability of Bright IDEAS was rated 5/5. This proposal is designed to meet the challenge inherent in this perfect score. The investigators will also immediately broaden the scope of users by including fathers as eligible participants in this study of a new delivery paradigm the investigators believe they will find appealing. Aim 1 is implementation of an engaging, easy-to-use on-line version of Bright IDEAS that would be available 24/7 to any person anywhere who has access to the Internet. Aim 2 is the use of "Diffusion of Innovations" theory to craft a framework for disseminating not only Bright IDEAS but other similar interventions with the greatest effectiveness and efficiency. In past studies, the investigators have shown that the human element (time and attention) inherent in in-person interventions is effective in bringing immediate relief of distress but not sufficient to maintain its benefits over time. In contrast, mothers receiving PSST increase their skills and continue to improve their sense of well-being 3 months after the intervention. What the investigators have not investigated is whether a computer-based intervention is as effective as (not inferior to) an in-person intervention. The results will have significant implications for future dissemination strategies, especially the use of Internet II and other emerging technologies.

Online Problem Solving Skills Training

Online Implementation of Problem Solving Skills Training for Mothers of Newly Diagnosed Childhood Cancer Patients

This is a well-validated assessment of the impact of a specified event (in this case, the diagnosis of cancer in a child)

This is a well-validated measure of the degree to which an individual born in another country has adopted the customs of their new country

This is a well validated assessment of the social, financial, and emotional ramifications associated with being a minority individual (in this case, Hispanic).

The Current Problems Inventory was developed by the investigators to provide examples of the kinds of problems commonly encountered in families with a child with cancer. This form has been completed by participants at T1 in all studies of Bright IDEAS PSST to date. During this project, the CPI will be given at T1, T2, and T3 to monitor change over time.

Includes information about the child with cancer (age, diagnosis, date of diagnosis), parental age, marital status, educational level, occupational prestige of the family, and previous experience with the Internet.

A 22-item self-report measuring perceived post-traumatic stress, includes three subscales (intrusion, avoidance, and hyperarousal) that assess PTS symptoms (PTSSx) during the past week experienced in response to a specific event. Widely used to measure PTSSx associated with events such as diagnosis with cancer. Internal consistency reliabilities of the intrusion, avoidance, and hyperarousal subscales are .91, .84, and .90, respectively.

Credibility is measured along four dimensions and expectancy is rated on a scale of 0 to 100. These rating scales were developed by the investigators specifically for this purpose and used in our most recent previous study.

Will be assessed using a 21-item questionnaire developed by the investigators to address intervention-specific and website-specific issues. Only the first five questions and the open-ended questions modified for the face-to-face group (specific to Bright IDEAS itself) will be completed by participants receiving the standard intervention. The questionnaire will be administered at T2.

This is a well validated assessment of problem-solving strategies and positive or negative orientation to problem solving.

This is a well validated measure of depression and anxiety

A 9-item self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ9 is the depression module which rates each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day). It will be used in place of the Beck Depression Inventory.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Simultaneous Care: Linking Palliation to Clinical Trials	NCT00283257	Solid Tumor Lymphoma	Patients and ca...	18 Years -	University of California, Davis
Maternal Problem-Solving in Childhood Cancer	NCT00234793	Stress Cancer	Problem-Solving...	-	University of Rochester
Online Problem Solving Skills Training	NCT01711944	Childhood Cance...	Problem-Solving...	18 Years -	University of Rochester
Simultaneous Care: Linking Palliation to Clinical Trials	NCT00283257	Solid Tumor Lymphoma	Patients and ca...	18 Years -	University of California, Davis
Online Problem Solving Skills Training	NCT01711944	Childhood Cance...	Problem-Solving...	18 Years -	University of Rochester

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