NCT03567850

Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC

Completed NA Results posted Last updated 28 September 2022

What this trial tests

NA trial testing Problem solving Skills Training in Colo-rectal Cancer in 50 participants. Completed in 9 March 2021.

Timeline

19 October 2018

Primary endpoint
9 March 2021

9 March 2021

Quick facts

Lead sponsor	Roswell Park Cancer Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	50
Start date	19 October 2018
Primary completion	9 March 2021
Estimated completion	9 March 2021
Sites	1 location across United States

Drugs / interventions tested

• Problem solving Skills Training

Conditions studied

• Colo-rectal Cancer — all drugs for Colo-rectal Cancer →

Sponsor

Roswell Park Cancer Institute

Who can join

21 and older, any sex, with Colo-rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Physical Health of Patient at Enrollment Primary · At enrollment

From all patients in the intervention and control arms, we will collect patient on physical health using the Functional Assessment of Cancer Therapy - disease specific. FACT-G is a 27-item questionnaire designed to measure four domains of health-related quality of life in cancer patients based on the past 7 days: physical, social, emotional, and functional well-being (score range is 1-108; higher scores indicate better quality of life). The scale's ability to discriminate patients on the basis of performance status and hospitalization status supports its sensitivity. It has also demonstrated

Group	Value	95% CI
Intervention	77.2	± 21.3
Control Arm	82.7	± 16.7

Behavioral Health of Patient Primary · At time of enrollment

From all patients in the intervention and control arms, we will collect patient self-report data on problem solving skills,using the Social Problem-Solving Inventory-Revised (SPSI-R) SPSI-R is a 25-item self-report tool linked to a multidimensional model of problem-solving skills. SPSI-R:S has been demonstrated to have strong reliability and validity estimates. The scale includes 5 sub-scales grouped into two decision-making styles: constructive (Positive Problem Orientation and Rational Problem Solving) and dysfunctional (Negative Problem Orientation, Impulsivity/ Carelessness, and Avoidance

Group	Value	95% CI
Intervention	12.2	± 3.7
Control Arm	11.7	± 3.7

Mean Change in Physical Health From Baseline to 3-months Primary · At 3 months

From all patients in the intervention and control arms, we will collect patient on physical health using the Functional Assessment of Cancer Therapy - Disease Specific (FACT) FACT-G is a 27-item questionnaire designed to measure four domains of health-related quality of life in cancer patients based on the past 7 days: physical, social, emotional, and functional well-being (score range is 1-108; higher scores indicate better quality of life). The scale's ability to discriminate patients on the basis of performance status and hospitalization status supports its sensitivity. It has also demonst

baseline

Group	Value	95% CI
Intervention	77.2	± 21.3
Control Arm	82.7	± 16.7

3-months

Group	Value	95% CI
Intervention	82.4	± 19.6
Control Arm	82.4	± 20.2

Mean Change Physical Health of Patient at 12 Months Primary · At 12 months

From all patients in the intervention and control arms, we will collect patient on physical health using the Functional Assessment of Cancer Therapy (FACT) FACT-G is a 27-item questionnaire designed to measure four domains of health-related quality of life in cancer patients based on the past 7 days: physical, social, emotional, and functional well-being (score range is 1-108; higher scores indicate better quality of life). The scale's ability to discriminate patients on the basis of performance status and hospitalization status supports its sensitivity. It has also demonstrated sensitivity t

baseline

Group	Value	95% CI
Intervention	77.2	± 21.3
Control Arm	82.7	± 16.7

12-months

Group	Value	95% CI
Intervention	87.1	± 21.5
Control Arm	82.3	± 18.9

Mean Change in Behavioral Health of Patient at 3 Months Primary · At 3 months

From all patients in the intervention and control arms, we will collect patient self-report data on problem solving skills,using the Social Problem-Solving Inventory-Revised (SPSI-R) SPSI-R is a 25-item self-report tool linked to a multidimensional model of problem-solving skills. SPSI-R:S has been demonstrated to have strong reliability and validity estimates. The scale includes 5 sub-scales grouped into two decision-making styles: constructive (Positive Problem Orientation and Rational Problem Solving) and dysfunctional (Negative Problem Orientation, Impulsivity/ Carelessness, and Avoidance

baseline

Group	Value	95% CI
Intervention	12.2	± 3.7
Control Arm	11.7	± 3.7

3-months

Group	Value	95% CI
Intervention	13.4	± 3.8
Control Arm	11.6	± 4.2

Mean Change in Behavioral Health of Patient at 12 Months Primary · At 12 months

From all patients in the intervention and control arms, we will collect patient self-report data on problem solving skills,using the Social Problem-Solving Inventory-Revised (SPSI-R) SPSI-R is a 25-item self-report tool linked to a multidimensional model of problem-solving skills. SPSI-R:S has been demonstrated to have strong reliability and validity estimates. The scale includes 5 sub-scales grouped into two decision-making styles: constructive (Positive Problem Orientation and Rational Problem Solving) and dysfunctional (Negative Problem Orientation, Impulsivity/ Carelessness, and Avoidance

baseline

Group	Value	95% CI
Intervention	12.2	± 3.7
Control Arm	11.7	± 3.7

12-months

Group	Value	95% CI
Intervention	13.8	± 3.1
Control Arm	11.7	± 4.5

Healthcare Utilization of Patients Primary · At 12 months

From all patients in the intervention and control arms, we will collect patient self-report data by asking the patients about their healthcare utilization since the last study assessment including primary care, specialist and ED visits, use of supportive services and any hospital stays.

Number of Hospital Visits

Group	Value	95% CI
Intervention	0.0	± 0.0
Control Arm	0.4	± 0.9

Number of Emergency Room Visits

Group	Value	95% CI
Intervention	0.0	± 0.0
Control Arm	0.3	± 0.9

Number of Ambulatory Services Used

Group	Value	95% CI
Intervention	6.5	± 4.7
Control Arm	5.7	± 3.9

Sponsor's own description

The aim of this 2-year study will assess the acceptability and feasibility of offering Problem Solving Skills Therapy (PSST) to cancer survivors and their caregivers focusing on the highest risk patients with distress.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Problem-solving skills training in adult cancer survivors: Bright IDEAS-AC pilot study.
   Noyes K, Zapf AL, Depner RM, Flores T, et al · · 2022 · cited 10× · PMID 35358820 · DOI 10.1016/j.ctarc.2022.100552