CompletedNot Applicable

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

United States50 participantsStarted 2018-10-19

Plain-language summary

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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * stage I-III Colorectal Cancer, Breast, Bladder or Prostate Cancer * meet the screening criteria for psychological distress (NCCN Distress \>2) * be able to speak English * have a 5-year survival rate of 50% or greater as deemed by their oncologist, surgeon,or other relevant attending physician (suggesting a reasonable rate of cure or prolonged medical survival with state-of-the-art medical care) * be willing to provide written informed consent to participate in the study which includes several clinical evaluations, provide access to medical records/PCP, and allow all interviews and PSST therapy sessions to be audiotaped. * Among patients treated in the urban centers, we will specifically target patients who live more than 40 miles away from the clinic as they are more likely to experience problems with access to care. * Age 21 or older Exclusion Criteria: * a diagnosis of mental retardation, * and/or acute suicidal behavior

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Physical Health of Patient at Enrollment

Timeframe: At enrollment

Behavioral Health of Patient

Timeframe: At time of enrollment

Mean Change in Physical Health From Baseline to 3-months

Timeframe: At 3 months

Mean Change Physical Health of Patient at 12 Months

Timeframe: At 12 months

Mean Change in Behavioral Health of Patient at 3 Months

Timeframe: At 3 months

Mean Change in Behavioral Health of Patient at 12 Months

Timeframe: At 12 months

Healthcare Utilization of Patients

Timeframe: At 12 months

Trial details

NCT IDNCT03567850

SponsorRoswell Park Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-09

Results submitted2022-08-02

View on ClinicalTrials.gov More Colo-rectal Cancer trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Physical Health of Patient at Enrollment

Timeframe: At enrollment

Behavioral Health of Patient

Timeframe: At time of enrollment

Mean Change in Physical Health From Baseline to 3-months

Timeframe: At 3 months

Mean Change Physical Health of Patient at 12 Months

Timeframe: At 12 months

Mean Change in Behavioral Health of Patient at 3 Months

Timeframe: At 3 months

Mean Change in Behavioral Health of Patient at 12 Months

Timeframe: At 12 months

Healthcare Utilization of Patients

Timeframe: At 12 months