Online Implementation of Problem Solving Skills Training for Mothers of Newly Diagnosed Childhood Cancer Patients
18 Years
N/A
Both
Childhood Cancer
Trial Information
Online Implementation of Problem Solving Skills Training for Mothers of Newly Diagnosed Childhood Cancer Patients
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.
Inclusion Criteria:
Subjects will be drawn from the pool of all parents who are primarycaregivers 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Social Problem Solving Skills Inventory
Outcome Description:
This is a well validated assessment of problem-solving strategies and positive or negative orientation to problem solving.
Outcome Time Frame:
baseline (T1), post intervention (3 months; T2), 3 months pist intervention (6 months; T3)
Safety Issue:
No
Principal Investigator
Olle Jane Z Sahler, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Rochester
Authority:
United States: Institutional Review Board
Study ID:
1 R01 CA159013-01A1
NCT ID:
NCT01711944
Start Date:
July 2012
Completion Date:
April 2017
Related Keywords:
- Childhood Cancer
- childhood cancer
- Internet communication
- parents
- caregivers
- problem solving
Name | Location |
|---|---|
| University of Rochester Medical Center | Rochester, New York 14642 |
