Clinical trial NCT01711944: Online Problem Solving Skills Training
Official title: Online Implementation of Problem Solving Skills Training for Mothers of Newly Diagnosed Childhood Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Keywords: childhood cancer
Internet communication
parents
caregivers
problem solving
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: University of Texas, El Paso
name: University of Colorado, Denver
name: University of Pittsburgh
name: Rutgers Cancer Institute of New Jersey
name: Children's Hospital Los Angeles
name: St. Jude Children's Research Hospital
name: National Institutes of Health (NIH)
First posted: 2012-10-22
Enrollment: 629
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: Subjects will be drawn from the pool of all parents who are primary caregivers of children diagnosed with any form of cancer 4-16 weeks prior to contact about the Problem Solving Skills Training intervention and cared for at one of the 4 data collection sites. No attempt will be made to stratify the sample by any particular demographic variables (e.g., age, ethnic background, or type of cancer diagnosed in their child), except that monolingual Spanish-speaking parents will be specifically recruited to provide adequate representation for statistical analysis at Childrens Hospital Los Angeles and UT/MD Anderson Cancer Center. Goal: 20% total enrollment.

Exclusion Criteria: Parents of children with cancer will be excluded if (1) they do not read or speak English or Spanish; (2) their child is in severe a medical crisis, as determined by the oncologist, or (3) they live a prohibitive distance to complete the intervention (typically, \>50 miles from the Center) and do not have access to a telephone for phone intervention sessions. Internet access will be facilitated as part of the e-PSST intervention arm. These exclusionary criteria are identical to our previous work; \<10% of eligible mothers have been excluded.

Primary outcomes:
measure: Social Problem Solving Skills Inventory
timeFrame: Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)
Secondary outcomes:
measure: Profile of Mood States
timeFrame: Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)
measure: Patient Health Questionnaire (PHQ9)
timeFrame: Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)
Other outcomes:
measure: Impact of Event Scale-Revised
timeFrame: Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)
measure: Bidimensional Acculturation Scale for Hispanics
timeFrame: Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)
measure: Hispanic Stress Inventory
timeFrame: Baseline (T1); post intervention (3 months; T2); 3 months post intervention (6 months; T3)
measure: Current Problems Inventory
timeFrame: Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)
measure: Demographic Information
timeFrame: Baseline (T1)
measure: Impact of Event Scale-Revised (IES-R)
timeFrame: Baseline (T1), post intervention (3 months; T2), 3 months post intervention (6 months; T3)
measure: Credibility/Expectancy
timeFrame: After the first face-to-face PSST or ePSST session and after the fourth face-to-face PSST session or four weeks after the first ePSST session
measure: User Satisfaction
timeFrame: Post intervention (3 months; T2)
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of Rochester
name: Olle Jane Z Sahler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phipps S, Fairclough DL, Noll RB, Devine KA, Dolgin MJ, Schepers SA, Askins MA, Schneider NM, Ingman K, Voll M, Katz ER, McLaughlin J, Sahler OJZ. In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial. EClinicalMedicine. 2020 Jun 27;24:100428. doi: 10.1016/j.eclinm.2020.100428. eCollection 2020 Jul.